Rapid HTA COVID-19 Tests

Rapid HTA of alternative diagnostic technologies for the detection of SARS -CoV-2
Health Information and Quality Authority
Rapid health technology

assessment of alternative
diagnostic testing approaches for
the detection of severe acute
respiratory syndrome coronavirus 2
(SARS-CoV-2)
5 May 2020
Safer Better Care

Rapid HTA of alternative diagnostic technologies for the detection of SARS -CoV-2
Rapid HTA of Alternative Diagnostic Technologies for the Detection of SARS -CoV-2
About the Health Information and Quality Authority

(HIQA)
The Health Information and Quality Authority (HIQA) is an independent statutory
authority established to promote safety and quality in the provision of health and
social care services for the benefit of the health and welfare of the public.
HIQA’s mandate to date extends across a wide range of public, private and voluntary
sector services. Reporting to the Minister for Health and engaging with the Minister
for Children and Youth Affairs, HIQA has responsibility for the following:
 Setting standards for health and social care services — Developing

person-centred standards and guidance, based on evidence and international
best practice, for health and social care services in Ireland.
 Regulating social care services — The Chief Inspector within HIQA is

responsible for registering and inspecting residential services for older people
and people with a disability, and children’s special care units.
 Regulating health services — Regulating medical exposure to ionising

radiation.
 Monitoring services — Monitoring the safety and quality of health services

and children’s social services, and investigating as necessary serious concerns
about the health and welfare of people who use these services.
 Health technology assessment — Evaluating the clinical and cost-

effectiveness of health programmes, policies, medicines, medical equipment,
diagnostic and surgical techniques, health promotion and protection activities,
and providing advice to enable the best use of resources and the best
outcomes for people who use our health service.
 Health information — Advising on the efficient and secure collection and

sharing of health information, setting standards, evaluating information
resources and publishing information on the delivery and performance of
Ireland’s health and social care services.
 National Care Experience Programme — Carrying out national service-

user experience surveys across a range of health services, in conjunction with
the Department of Health and the HSE.
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Contents
Acknowledgements .............................................................................................. 4
Members of the Evaluation Team: ......................................................................... 4
Conflicts of interest .............................................................................................. 4
List of abbreviations used in this report ................................................................. 5
Executive summary .............................................................................................. 7
1. Background ................................................................................................. 18
2. Description of the technology ....................................................................... 20
Key points ...................................................................................................... 20
2.1. Coronaviruses ........................................................................................ 20
2.2. Diagnostic testing .................................................................................. 21
2.3. Pathogen detection tests ........................................................................ 22
2.3.1. Molecular methods .......................................................................... 22
2.3.2. Antigen detection tests .................................................................... 25
2.3.3. Viral culture..................................................................................... 26
2.3.4. Microarray or microfluidic lab-on-chip technologies for the detection of
viral RNA or antigens ................................................................................... 26
2.4. Detection of immune response ............................................................... 27
2.4.1. Antibody tests ................................................................................. 27
2.4.2. Microarray or microfluidic technology for the detection of antibodies .. 27
2.5. Rapid tests ............................................................................................ 28
2.6. Selection and interpretation of tests ........................................................ 29
3. International approaches to diagnostic testing ............................................... 34
Key points ...................................................................................................... 34
3.1 International guidance ........................................................................... 34
3.2 Recent international developments in diagnostic testing ........................... 36
3.3 Discussion ............................................................................................. 38
4. Operational utility ........................................................................................ 42
Key points ...................................................................................................... 42
4.1 Introduction ............................................................................................. 42
4.1. Methods of viral detection for acute infection .......................................... 44
4.2. Methods detecting the host immune response ......................................... 48
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5. Diagnostic tests approved for use internationally ........................................... 52

Key points ...................................................................................................... 52
5.1 Introduction .......................................................................................... 52
5.2 An overview of the international regulatory processes .............................. 52
5.3 Tests approved or authorised for use internationally ................................ 53
5.4 Discussion ............................................................................................. 54
6. Performance characteristics .......................................................................... 55
Key points ...................................................................................................... 55
6.1 Introduction ............................................................................................. 56
6.2 Methods ................................................................................................... 56
6.3 Findings ................................................................................................... 58
7. Discussion ................................................................................................... 63
8. Conclusions ................................................................................................. 68
References ........................................................................................................ 70
Appendix A – List of internationally approved or authorised SARS-CoV-2 tests ....... 79
Appendix B – Manufacturer-reported characteristics of SARS-CoV-2 tests ............ 106
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Acknowledgements
HIQA would like to thank all of the individuals and organisations who provided their
time, advice, and information in support of this rapid assessment. Particular thanks
are due to Dr Cillian F De Gascun (Director, National Virus Reference Laboratory), Dr
Mary Keogan (National Clinical Lead, National Clinical Programme for Pathology,
Health Service Executive [HSE]), Judith Martin (IVD Lead, Assessment & Surveillance
– Medical Devices, Health Products Regulatory Authority [HPRA]), Philip Kelly
(HPRA), Professor Martin Cormican (National Clinical Lead, AMRIC, HSE) and Dr
Derval Igoe (Specialist in Public Health Medicine, Health Protection Surveillance
Centre [HPSC]).
Members of the Evaluation Team:
Members of HIQA’s Evaluation Team include Dr Patricia Harrington, Paul Carty, Dr

Christopher Fawsitt, Karen Jordan, Dr Kirsty O’Brien, Dr Kieran Walsh, Dr Conor
Teljeur, Dr Máirín Ryan.
Conflicts of interest
None reported.
Version history
Version Date Description of change

V1.0 22.04.2020 Date of first publication
V1.1 05.05.2020 Minor wording amendments in chapters 5
and 6
Updated Table A.1 in Appendix A
Addition of Table A.2 in Appendix A
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List of abbreviations used in this report

ARI acute respiratory infection
ARTG Australian Register of Therapeutic Goods
CE Conformité Européenne
CDC Centre for Disease Prevention and Control
cDNA complementary deoxyribonucleic acid
COVID-19 Coronavirus disease 2019
CRISPR clustered regularly interspaced short palindromic repeats
CT computed tomography
CTS common technical specifications
DNA deoxyribonucleic acid
DTA diagnostic test accuracy
EC European Commission
ECDC European Centre for Disease Prevention and Control
ELISA enzyme-linked immunosorbent assays
EUA Emergency Use Authorization
FDA Food and Drug Administration
FSCA field safety corrective actions
HIQA Health Information and Quality Authority
HIV human immunodeficiency virus
HPRA Health Products Regulatory Authority
HSE Health Service Executive
HTA health technology assessment
HZI Helmholtz Centre for Infection Research
ICU intensive care unit
IFA immunofluorescence assays
IgG immunoglobulin G
IgM immunoglobulin M
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ILI influenza-like illness
IVD in vitro diagnostics
IVDR In Vitro Diagnostic Regulation
JRC Joint Research Centre
MERS Middle East Respiratory Syndrome
MHRA Medicines and Healthcare products Regulatory Authority
NAAT nucleic acid amplification technology
NPHET National Public Health Emergency Team
RNA ribonucleic acid
RT-LAMP reverse transcription loop-mediated isothermal

amplification
RT-PCR reverse transcription polymerase chain reaction
SARI severe acute respiratory infections
SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
SHERLOCK Specific High Sensitivity Enzymatic Reporter UnLOCKing
TGA Therapeutic Goods Administration
WHO World Health Organization
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Executive summary
The Health Information and Quality Authority (HIQA) was requested to undertake a
rapid health technology assessment (HTA) of alternative diagnostic testing methods
for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
to inform the work of the National Public Health Emergency Team (NPHET) in their
response to the COVID-19 (coronavirus disease 2019) pandemic. The World Health
Organization (WHO) has identified that diagnostic testing for SARS-CoV-2 infection is
critical to tracking the viral spread, understanding epidemiology, informing case
management, and reducing transmission.
The assessment was undertaken as a rapid HTA within very restricted timelines and
in the context of an evolving global pandemic of a new pathogen in humans. It
therefore differs from a standard HTA in its scope and the approaches adopted to
synthesising the available evidence.
At the request of NPHET, HIQA investigated the potential usefulness of alternative

diagnostic tests for the detection of SARS-CoV-2, whether any of the tests that are
commercially available are being used internationally, and identified when the tests
could be deployed in the clinical pathway.
Potential alternative diagnostic approaches
Diagnostic tests for SARS-CoV-2 can broadly be grouped into two categories, those
aimed at:
 pathogen (virus) detection (acute infection)
 detection of immune response to the pathogen (past exposure).
Reverse transcription polymerase chain reaction (RT-PCR) facilitates direct detection

of SARS-CoV-2 RNA. It is characterised by high sensitivity and specificity, and is
regarded as the gold standard for clinical diagnostics. The initial identification of the
SARS-CoV-2 virus was based on non-commercial RT-PCR laboratory protocols which
were published on the World Health Organization (WHO) website. The testing
protocols include multiple steps involving manual manipulation and take six to seven
hours to complete. However, RT-PCR is not a new technology; it is widely used in
specialised diagnostic virology laboratories. Therefore, companies have developed
and commercialised RT-PCR test kits, many of which work off existing platforms
already deployed in Irish hospital and diagnostic virology laboratories.
Potential alternative or additional approaches to RT-PCR considered in this

assessment include: serological testing (for antibodies and antigens); microarray or
microfluidic lab-on-chip technologies; CRISPR to isolate gene segments; and full
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genetic sequencing. Rapid tests involving in-vitro diagnostics (IVDs) which have the
potential to be used at or near the point of care (near-patient testing) were also
considered.
Operational utility
Pathogen detection tests (such as RT-PCR) and tests to detect an immune response
to the virus (development of SARS-CoV-2-specific antibodies) should not be
considered competing alternatives. Both testing approaches are clinically relevant,
but must be deployed at different time points during the clinical course of infection
taking consideration of their relevant diagnostic windows (Figure ES1).
Figure ES1: Diagnostic windows for the detection of acute SARS-CoV-2 infection
(viral RNA) and the immune response (anti-SARS-CoV-2 IgM and IgG) indicating
past exposure to SARS-CoV-2
Note: *While the sequence of events is well understood, the exact timeline is based on early
evidence summaries and is subject to considerable uncertainty.
Case finding – detection of acute infection
RT-PCR is the ‘gold standard’ recommended for use by the WHO and ECDC for the
diagnosis of COVID-19 cases during the acute phase of infection. It is indicated for
the detection of SARS-CoV-2 RNA early in the clinical course of infection. False
negative results can occur if testing takes place in the initial incubation period
following infection. The minimum duration from infection to a positive test remains
uncertain. Using RT-PCR, SARS-CoV-2 viral RNA can be detected one-to-two days
prior to symptom onset in upper respiratory tract samples (Figure ES1). Based on
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limited early data, viral load peaks around the time of symptom onset, with viral RNA
becoming undetectable (from upper respiratory tract specimens) approximately two
weeks following symptom onset. The diagnostic window for using RT-PCR to detect
acute infection with SARS-CoV-2 therefore ranges from approximately three days
following exposure to the virus until two weeks following symptom onset (Figure
ES1).
Antigen detection tests, including rapid antigen tests, could be used to facilitate
early diagnosis of acute infection with SARS-CoV-2. In general, available antigen
detection tests, although associated with operational advantages in terms of ease-
of-use and turnaround time, are less sensitive when compared with RT-PCR. A highly
sensitive test is necessary to prevent false negative results and the risk of potential
virus transmission. In the absence of independent validation, the WHO has advised
against the use of rapid diagnostic tests based on antigen detection in any setting
(except research settings), including for decision-making, until evidence supporting
their use for specific indications is available. Consideration may, in future, be given
to the use of rapid antigen tests as triage tests to rapidly identify patients who are
considered very likely to have COVID-19 based on clinical symptoms and
epidemiological risk factors, thereby reducing the need for molecular (RT-PCR)
confirmatory testing.
Identification of prior infection
Direct viral detection methods such as RT-PCR and antigen detection tests cannot be
used to identify past exposure to SARS-CoV-2. To identify those who have been
exposed to SARS-CoV-2, tests that detect antibodies (IgM and IgG) produced by the
body in response to SARS-CoV-2 infection can be used. Antibodies are typically
detectable 7-to-14 days (a week to a fortnight) after the onset of symptoms.
Therefore, antibody detection tests are not useful for early case finding.
As SARS-CoV-2 is a new pathogen in humans, little is known regarding the adequacy

of the immune response or the duration of immunity following seroconversion
(development of SARS-CoV-2-specific antibodies). Therefore, it is not known if
reinfection can occur, although there is no reason to assume it cannot. In addition,
as with the influenza virus, there is potential for antigenic drift, and thus the
potential that any immunity following infection would be limited to the initial strain of
the virus.
A highly specific test is necessary to prevent false positive results, whereby

individuals are incorrectly classified as potentially being immune to SARS-CoV-2,
when they are still at risk of contracting the infection. Similar to the rapid antigen
tests, the WHO has advised against the use of rapid antibody tests in any setting
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(except research settings), including for decision-making, until evidence supporting

their use for specific indications is available.
The operational utility of antibody detection tests can be considered in the context of
three potential scenarios:
 Patient-level testing to inform clinical management. For example, in

addition to any existing requirements to confirm disappearance of viral RNA, a
decision to de-escalate care for patients hospitalised with COVID-19 could be
informed by additional antibody testing to detect the presence of IgG
antibody specific to SARS-CoV-2.
 Cohort testing to inform staff deployment. For example, proposed

‘immunity passports’ to enable staff with immunity to the virus to return to
work, or in the context of healthcare workers, preferential deployment of staff
with acquired immunity to high-risk areas on the basis that they would not be
considered at risk of contracting or spreading the disease.
 Population level seroepidemiological studies to inform public health

strategies. Surveillance studies based on detection of antibodies specific to
SARS-CoV-2 could be a useful public health tool to assess overall infection
and immunity rates in the population (for example, those immune due to
mild, asymptomatic or recovered infection) and so inform the relaxation of
public health measures. However, issues in relation to cross-reactivity to other
coronaviruses (that is, risk of false-positives) and persistence of immunity
require clarification. Surveillance studies are planned or underway in a
number of countries including Germany, France, and the UK.
The level(s) at which such antibody detection tests might be deployed has extremely
important implications for both the administration and reporting of tests as well as
the overall governance of any testing strategy. This is particularly the case for
testing to inform staff redeployment given the uncertainty around the effectiveness
and durability of the antibody response, and the potential for re-infection with the
same or a different antigenic strain of the SARS-CoV-2 virus.
The use of population-level antibody detection studies to inform a public health

response is well documented in the context of other viral respiratory pathogens.
Such studies are resource intensive. Interpretation of the findings is critically
dependent on a wide range of factors including the demographics of the population
tested, the specificity of the test used and issues relating to the sample type and
handling. Any decision to implement population-level testing should therefore only
be undertaken in the context of a well-designed research study with governance and
controls usual to such studies.
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Current international practice
A brief scoping review was undertaken to identify the diagnostic approaches being
recommended internationally. Included in the review were international agencies
and a limited number of European and non-European countries.
The WHO, ECDC, and the CDC in the US recommend using laboratory-based nucleic
acid amplification (molecular) tests (manual or automated), such as RT-PCR to
detect the SARS-CoV-2 RNA (as of 14 April 2020). The same molecular test has been
recommended for use to detect acute infection with SARS-CoV-2 in Ireland and the
UK, among other countries.
Microfluidic lab-on-chip technologies and genetic sequencing do not appear to be

used at a national level in any country for the detection of COVID-19. Although not
yet CE-marked, a microarray respiratory panel incorporating SARS-CoV-2 is reported
to be in use in the UK. Genomic surveillance will be important to monitor the virus
for the appearance of mutations and to identify stable targets for nucleic acid based
detection methods. Viral genome sequences could also inform the development of
treatments and vaccines. In the UK, the COVID-19 Genomics UK Consortium,
comprising the National Health Service (NHS), Public Health England, UK Research
and Innovation (UKRI), and Wellcome has been launched to track viral spread and
evolution via genome sequencing of COVID-19 samples.
The WHO and ECDC recommend that a serum sample for serology (that is, antibody
testing) should be collected and stored during the acute phase of illness (that is,
after symptom onset), with a second serum sample collected two-to-four weeks
later, during the convalescent phase. Having a baseline sample allows confirmation
that seroconversion has occurred. It can also facilitate retrospective case definition
in individuals who did not have timely access to RT-PCR to confirm acute infection.
While not implemented at a national level, there is anecdotal evidence that rapid
antibody tests have been deployed in a number of healthcare settings (Veneto and
Emilia-Romagna regions in Italy; Mount Sinai Hospital and Mayo Clinic in the US).
Availability of diagnostic tests approved for use internationally
In Europe, tests for COVID-19 (SARS-CoV-2) which are CE marked in accordance

with the In Vitro Diagnostic Medical Devices Directive (IVDD; 98/79/EC) may be
placed on the market. Under this Directive, manufacturers of tests for COVID-19
(SARS-CoV-2) are required to specify device performance characteristics and self-
declare conformity with the safety and performance characteristics outlined in the
Directive. Self-tests for COVID-19 (SARS-CoV-2) require independent assessment by
a Notified Body to ensure the requirements of the IVD Directive are met. New
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technologies for the diagnosis of COVID-19 are rapidly emerging and regulatory
agencies are responding quickly to this emerging pathogen. This has included the
creation of pathways to accelerated regulatory approval to meet worldwide demand
for diagnostic testing (for example FDA‘s Emergency Use Authorization). In Europe,
due to the scale of the pandemic, some regulatory authorities are facilitating the
placement on the market of non-CE marked IVDs deemed critical for COVID-19
diagnosis through national derogations.
In Ireland, the Health Products Regulatory Authority (HPRA) is the Competent

Authority (CA) for medical devices and IVDs, and monitors the safety of medical
devices and IVDs after they have been placed on the market. The HPRA has
developed a regulatory derogation process for the urgent assessment of applications
to facilitate the use of critical non-CE marked medical devices and IVDs in the
context of the COVID-19 emergency in Ireland.
A list of test devices for detection of SARS-CoV-2 was compiled through a review of
data from a variety of government organisations and grey literature sources
including online repositories (such as the non-governmental organisation, FIND).
Performance of commercialised diagnostic tests
While a systematic review of the literature is routinely used in HTAs to assess

diagnostic test accuracy, this approach was not adopted in this rapid assessment as
such a review was considered premature at this point. SARS-CoV-2 is a novel
pathogen in humans first detected in December 2019. Literature published in the
first four months of this year are primarily in the form of case reports and case
series. These would require confirmation using larger more robust study designs. It
is also noted that at the time this assessment was being undertaken, the majority of
the publications had not undergone peer-review, therefore the study findings should
be interpreted with caution.
In the absence of a centralised list of verified CE-marked tests, a review of grey

literature sources including online repositories (such as the non-governmental
organisation, FIND) was undertaken to identify IVD tests for COVID-19 claiming CE-
marking. Due to time constraints, the claimed CE-marking was not verified with
relevant authorities. The characteristics and performance of a convenience sample of
these tests was reviewed to illustrate the range of IVDs commercialised for COVID-
19. The performance data are limited to manufacturer-reported characteristics, so
may be subject to bias.
A large number of RT-PCR test kits were identified. The initial RT-PCR testing
protocols approved and validated for SARS-Co-V2 detection include multiple steps
involving manual manipulation and take six to seven hours to complete. Newly-
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developed kits incorporate existing technological advances and can be used in

platforms with a higher degree of automation, requiring less manual manipulation,
less reagent and that are amenable to batch testing, thereby facilitating quicker
turnaround time and a higher throughput of tests.
Advantages of test kits suitable for use on existing platforms include the fact that
the platforms are already deployed in a number of the hospital laboratories, so there
is a level of multidisciplinary experience and confidence in their use.
A large number of laboratory-based RT-PCR tests were identified, including a range

of tests identified as being CE-marked by the manufacturer. A review of a
convenience sample of these tests showed inconsistent reporting of diagnostic test
accuracy results. Where reported, manufacturer-reported clinical sensitivity ranged
from 89% to 100%, and clinical specificity ranged from 98% to 100%.
Given the need for specialised equipment and reagents, technically skilled staff and
potential long turnaround times with RT-PCR, alternative diagnostic methods with
comparable accuracy and reduced operational requirements are needed. There is
evidence to suggest that nucleic acid detection-based methods such as CRISPR and
RT-LAMP may have comparable diagnostic test accuracy to RT-PCR, and may have
operational advantages in terms of ease-of-use and turnaround time. Many of these
devices are still in the development stage. In our initial review, commercially
available CE-marked tests using these methodologies were not identified.
Rapid antigen and antibody tests
Although an increasing number of alternative diagnostic tests are being developed

and commercialised, there is considerable uncertainty regarding the clinical
performance of these tests, in particular rapid SARS-CoV-2 antigen detection tests
and rapid antibody tests.
Using publicly available information from the non-governmental organisation, FIND,

the ECDC reported that ten rapid antigen IVDs conform with the relevant EU
legislation, Directive 98/79/EC on in-vitro diagnostic medical devices (IVDs), and
may be available for use internationally. However, they noted that they may be
targeted to third-country markets and may not be available for purchase in the EU.
According to authorities in 18 European countries, three rapid antigen tests have
been reported as CE-marked, as of 26 March. However, no manufacturer data on
the accuracy of these tests were identified. No data to support their independent
validation has been published.
The ECDC reported that over 60 rapid SARS-CoV-2 antibody tests have been CE
marked to date, and many more continue to be placed on the market. As noted, CE-
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marking of tests for COVID-19 (SARS-CoV-2), with the exception of self-tests, is

based on self-declaration. In a review of a convenience sample of these tests
claiming CE-marking, diagnostic accuracy results were inconsistently reported.
Manufacturer estimates of clinical sensitivity ranged from 85% to 100%, and clinical
specificity from 96% to 100%. However, these ranges should be interpreted with
caution given that the reference standard used for comparison was not always
reported by manufacturers. As yet, none of the rapid antibody tests have been
independently validated, and, to date, there are no CE-marked antibody tests for
self-testing available.
Pre-analytical vulnerabilities, independent clinical validation and quality

assurance
The pre-analytical phase can be a major source of errors in diagnostic testing. To

mitigate such risks, training and quality assurance procedures are required to ensure
that test samples are appropriately identified and reported (right result, right
patient), and to ensure adequate procedures for correct specimen (for example,
swab) collection, handling, transport, and storage.
Performance of both laboratory-based tests and rapid tests performed outside the
laboratory (near-patient tests) may differ to that reported by manufacturers for the
purposes of CE-marking. Prior to their introduction as standalone diagnostic tests,
independent clinical validation of the diagnostic performance compared with a
reference standard is considered best practice.
On the 16 April 2020, the European Commission published a working document that
provides additional guidance to the legally obligatory requirements defined in the
IVDR. The guidelines highlight the distinction between analytical performance
(usually evaluated based on a number of well-defined laboratory samples and
extreme patient samples) and diagnostic test accuracy which should be performed in
clinical studies using head-to-comparison between the test under assessment and
the reference test in the target population intended to be tested. Based on the
principles of good analytical (testing) practice, these guidelines include performance
criteria for RT-PCR, antigen-based and antibody-based tests. The current absence of
control samples and reference materials are noted as a particular challenge to
establishing the diagnostic test accuracy of antigen and antibody tests.
Commercialised, CE-marked, rapid tests are being assessed by WHO referral

laboratories and in clinical validation studies funded by the European Commission
and EU member states. The results of the validation studies will be published as
soon as they are available to inform decision-making regarding their potential use.
At that point, the WHO and ECDC have noted that they will update their guidance on
testing using these validated diagnostic testing approaches, which may be used in
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laboratories or near the point of care. Until these studies have been validated, the
WHO strongly advises against the use of rapid tests, in particular antigen detection
and host antibody detection tests, in any setting other than research.
In addition to independent external validation studies, additional verification studies

are considered best practice prior to test deployment. This is to ensure adequate
performance of the tests in the context in which they are being used. For RT-PCR
test kits, clinical validation of the diagnostic performance of the test kit should be
compared with an existing validated protocol for the gold-standard, but may be
conducted on the basis of a truncated validation run involving fewer samples, with
risk mitigated by enhanced surveillance of test performance, given the current
requirements for rapid deployment.
While adequate test accuracy and precision may be achieved under idealised
circumstances in the laboratory, these may be negatively impacted when used at the
point of care. Appropriate staff training and use of robust standardised operating
procedures may be required to moderate these sources of error.
In accordance with existing Irish guidelines for the safe and effective management
and use of near-patient (point-of-care) diagnostic tests, such testing should be
performed in the context of an ongoing quality assurance programme to ensure
adequate performance of the tests in the context in which they are being used and
provide confidence in the test results for both the diagnosing physician and the
patient. Consideration should also be given to a requirement that all testing should
be ISO-accreditable, including meeting requirements in relation to internal quality
control, quality assurance and the recording of training and test results.
Conclusions
This assessment was undertaken as a rapid HTA within very restricted timelines and
synthesising the available evidence. Evidence to support the analytical performance
of diagnostic tests for SARS-CoV-2 will continue to emerge. Evidence will also
emerge to support the clinical effectiveness and safety of different testing strategies
to inform patient care and the public health response to COVID-19. Revisions to any
national testing strategy may be required as the evidence evolves. In time, a full
HTA that takes consideration of the cost-effectiveness, resource considerations and
budget impact of alternative testing strategies may be required to ensure the best
outcomes for the resources available.
Bearing in mind the caveats of the approach adopted, and arising from the findings
of this report, the following conclusions can be drawn:
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 Diagnostic tests for SARS-CoV-2 can be broadly grouped into two categories:
those aimed at detecting the virus and those that detect the body’s immune
response to the infection (past exposure to the virus). These should not be
considered competing alternatives; both testing approaches are clinically
relevant at different time points during the clinical course of infection.
 The ability of any diagnostic test to achieve an acceptable clinical performance

is contingent on it being performed within the appropriate timeframe for the
condition in question (right test, right time, right person), with due
consideration of the principles of good pre-analytical and analytical testing
practice.
 Real-time PCR is the preferred method to detect SARS-CoV-2 RNA and to

confirm acute infection early in the clinical course of COVID-19 disease. To
increase diagnostic testing capacity, efforts are underway to develop enhanced
molecular methods with reduced turnaround times and instrumentation
requirements and higher throughput.
 Antigen detection tests could be used to supplement current laboratory-based

real-time RT-PCR case detection. However, analytical and clinical validation of
these tests is needed to inform their safe and effective use in clinical decision-
making.
 Contingent on the availability of accurate, validated tests, antibody tests could

be used later in the clinical course of infection or following recovery to identify
those who have been exposed to SARS-CoV-2. While the use of antibody tests
to provide ‘immunity passports’ has been proposed in the literature, little is
known about the adequacy of the immune response or the duration of
immunity, and so it is not known if reinfection can occur. The primary role of
antibody tests is likely to be as part of well-constructed seroprevalence studies
to model the course of the pandemic and inform the public health response.
 Work is currently underway to validate the analytical performance of the

different diagnostic tests. Prior to their introduction as standalone tests, clinical
validation studies are also required to confirm that test performance can be
replicated in the context in which the test is being used. All testing should be
undertaken in the context of an ongoing quality assurance programme to
provide confidence in the test results for both the physician and the patient.
 A cohesive national strategy is needed to ensure the right tests are undertaken
in the right people at the right time for the right purpose. This is necessary to
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ensure appropriate governance of SARS-CoV-2 testing and should include clear

criteria for the administration and reporting of tests. Planning now to support
delivery of the strategy will facilitate rapid deployment of tests that meet the
requisite standards once available and validated for use.
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1. Background
The Health Information and Quality Authority (HIQA) has been asked to summarise
the best available evidence regarding the diagnostic testing methods for the
detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to
inform the work of the National Public Health Emergency Team (NPHET) in their
response to COVID-19 (Coronavirus Disease 2019). The World Health Organization
(WHO) has identified that diagnostic testing for SARS-CoV-2 infection is critical to
tracking spread of the virus, understanding epidemiology, informing case
management, and reducing transmission.
The assessment was undertaken as a rapid assessment within very restricted

timelines and in the context of a global pandemic involving a new pathogen. It
therefore differs from a standard health technology assessment (HTA) in its scope
and the approaches adopted to synthesising the available evidence.
The request noted that most of the available diagnostics have focused on packaging
the appropriate reagents, genetic primers and probes for using reverse transcription
polymerase chain reaction (RT-PCR) to amplify genetic material for detection of
SARS-CoV-2 RNA. In this context, the following questions were posed which inform
the scope of the report:
1. What are the potential alternative approaches to RT-PCR, including:

 serological testing
 microarray or microfluidic lab-on-chip technologies
 CRISPR to isolate gene segments for diagnostics
 full genetic sequencing
 rapid tests (suitable for near-patient testing)?
2. What alternative diagnostic testing approaches are currently being used
internationally?
3. What is the rationale for, and operational utility of, serological tests (or other
approaches) in the ‘pre-symptomatic-symptomatic-full resolution’ clinical
pathway (for example, rapid diagnostics, seroprevalence studies)?
4. What alternative diagnostic tests have been CE-marked for use in Europe and
or approved or authorised for use by the US Food and Drug Administration,
among other international regulatory authorities?
5. What are the performance characteristics of alternative diagnostic testing
approaches, including:
 sensitivity and specificity
 turnaround time
 deployment approaches
 organisational and or infrastructural requirements?
Page 18 of 121
These questions are addressed in sequence in Section 2 to Section 6. A general

discussion of key issues likely to be of relevance to decision making by the NPHET in
relation to deployment of the alternative testing approaches is provided in Section 7.
Work on this assessment was informed by detailed discussions and feedback from
expert stakeholders in this area, specifically:
 National Clinical Lead for the HSE’s National Clinical Programme for
Pathology
 National Clinical Lead for the HSE’s Antimicrobial Resistance and Infection
Control Team
 Director of the National Virus Reference Laboratory
 Health Products Regulatory Authority (HPRA) which is designated as the
Competent Authority (CA) for medical devices and in vitro diagnostic
medical devices (IVDs) in Ireland.
Page 19 of 121
2. Description of the technology
Key points
 Real-time RT-PCR is the current gold standard for the detection of SARS-CoV-
2 RNA during the acute stage of COVID-19 disease.
 RT-PCR has many limitations including the need for specialised equipment
and reagents, technically skilled staff and long turnaround times.
 Alternative isothermal nucleic acid amplification methods (for example, RT-

LAMP) may have advantages over real-time RT-PCR in terms of ease-of-use
and turnaround time.
 Antigen detection tests detect the presence of viral proteins in clinical

samples. While generally less accurate than real-time RT-PCR, they have a
faster turnaround time, and are easier to operate.
 Antibody tests detect antibodies (IgM and IgG) produced by the immune
system in response to infection with SARS-CoV-2.
 Rapid tests have been developed for use in near-patient or resource-

constrained settings to accelerate clinical decision-making and expand testing
capacity.
 Surveillance using genetic sequencing will be important to identify any

mutations in the virus that may reduce the sensitivity of diagnostic tests.
2.1. Coronaviruses
Coronaviruses are a large family of viruses that circulate among animals including
camels, cats and bats. They can be spread from animals to humans. Coronaviruses
cause illness in humans ranging from the common cold to more severe respiratory
(lung) diseases.(1) Symptoms can include cough, shortness of breath, difficulty
breathing and fever. In more severe cases, pneumonia, severe acute respiratory
syndrome, kidney failure and death can occur.(2)
To date, seven coronaviruses have been shown to infect humans. Common human
coronaviruses including Alphacoronavirus HCoV-229E, Betacoronavirus HCoV-OC43,
and HCoV-HKU1 and Alphacoronavirus HCoV-NL63 are generally associated with
mild clinical symptoms. Additional zoonotic coronaviruses (SARS-CoV and Middle
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East respiratory syndrome coronavirus [MERS-CoV]) have emerged and have been
associated with more severe complications.(2)
In December 2019, a virus that had not previously been seen in humans was
identified in Wuhan, China. SARS-CoV-2 (previously known as 2019 Novel
coronavirus [2019-nCov]) shares a high degree of sequence similarity with SARS-
CoV.(3) Therefore, diagnostic testing approaches must be aimed at target gene
sequences or their resultant proteins that are specific to SARS-CoV-2.
2.2. Diagnostic testing
The World Health Organization (WHO) recognises that there is no universal best
practice approach to the management of COVID-19, and that good laboratory
practices that produce consistently accurate results are key to assuring that
laboratory testing supports the public health response.(4) There is a need to provide
guidance on the best available testing methodologies under different public health
scenarios for identification of current or resolved cases to inform public health
measures. Diagnostic testing for SARS-CoV-2 infection is critical to tracking the viral
spread, understanding epidemiology, informing case management, and reducing
transmission.(4)
Testing methods available for the detection of SARS-CoV-2 infection include those
aimed at pathogen detection and those aimed at detecting the immune response to
the pathogen.
Pathogen detection tests (discussed in section 2.3) include
 Molecular methods (discussed in section 2.3.1) to detect viral RNA including

RT-PCR, isothermal RNA amplification methods and genetic sequencing.
 Antigen detection tests (discussed in section 2.3.2).
 Viral culture (section 2.3.3).
 Microarrays and microfluidic technologies (discussed in section 2.3.4) can be

designed to detect a range of targets including viral RNA, antigens
Detection of the host immune response (discussed in section 2.4):
 Antibody tests.
 Microarrays and microfluidic technologies which can also be developed to

detect antibodies.
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Rapid tests (discussed in section 2.5) are in vitro diagnostic (IVD) medical devices
which involve non-automated procedures and have been designed to give a fast
result for near-patient (point-of-care) testing. These include pathogen detection
tests and tests to detect the immune response.
A summary of the testing methods available is provided in Table 2.1 at end of this
section along with a brief description of the suggested advantages, limitations and
potential applications of these technologies.
2.3. Pathogen detection tests

2.3.1. Molecular methods
Reverse-transcription polymerase chain reaction (RT-PCR)
Reverse transcription polymerase chain reaction (RT-PCR) is a genetic amplification

technique that measures RNA expression levels. In RT-PCR, complementary DNA
(cDNA) is made by reverse transcription of RNA templates with the enzyme reverse
transcriptase. This technique can be used to:
 qualitatively study gene expression
 relatively or absolutely quantitate RNA levels (real-time RT-PCR).(5)
RT-PCR facilitates direct detection of SARS-CoV-2 genetic material in various patient

specimens such as blood, stool, respiratory secretions or body tissues and can be
used for early diagnosis. Real-time RT-PCR (that is, the amplification of target RNA is
monitored as it occurs) is characterised by high sensitivity and specificity, and is
regarded as the gold standard for clinical diagnostics.(6, 7)
The first RT-PCR tests for detecting SARS-CoV-2 were designed and distributed in
January 2020 by the World Health Organization (WHO). Protocols for RT-PCR testing
have been developed by other countries (including Germany, Hong Kong, China,
Thailand, Japan and France), some of which have been made available on the WHO
website.(4) The protocol for testing in the US is available on the Centre for Disease
Control and Prevention’s (CDC) site.(8)
These RT-PCR assays target one or more of the following genes of SARS-CoV-2:
 open reading frame1a/b (ORF1a/b)
 ORF1b-nuclear shuttle protein14 (ORF1b – nsp14)
 RNA-dependent RNA polymerase (RdRp)
 spike (S)
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 envelope (E)
 nucleocapsid (N) genes.(9)
Despite its widespread use, RT-PCR has many limitations including the requirement
for highly skilled staff and specialised laboratory instrumentation for sample
processing, as well as long reaction times. These disadvantages limit its practical
application, and thus can delay the rapid identification and isolation of individuals
with COVID-19, thereby potentially contributing to onward disease transmission.
Technological advances and variations of RT-PCR
The initial testing protocols include multiple steps involving manual manipulation and
take six to seven hours to complete. However, RT-PCR is not a new technology; it is
widely used in specialised laboratories for viral testing. Companies have developed
and commercialised RT-PCR test kits, many of which work off existing platforms
already deployed in hospital and testing laboratories. These kits incorporate existing
technological advances that increase the convenience of testing and reduce test
processing times (see Figure 2.1). Use of rapid RT-PCR kits should leverage existing
laboratory resources to optimise the expansion of testing.
Figure 2.1: Technological advances leading to improved efficiency of nucleic acid
amplification-based testing procedures
Key: A – Amplification; D – Detection; E – Extraction; NPT – near-patient test; RT-PCR – reverse transcription
polymerase chain reaction. Figure adapted from Loeffelholz et al.(10)
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Real-time RT-PCR combines amplification and detection into a single step thereby
monitoring the generation of PCR products as it occurs (Figure 1, B and D). Real-
time RT-PCR is favoured for viral diagnostics due to the reduced turnaround time.
In the one-step real-time RT-PCR method, reverse-transcription and PCR are carried
out in the same tube.(11) One-step protocols are in development as another potential
strategy to increase the convenience of RT-PCR. Two-step methods involve the
creation of cDNA in a separate reverse-transcription reaction, followed by the
addition of this cDNA to the PCR reaction. While one-step methods increase ease of
use, they are usually less sensitive as it is impossible to optimise the two reactions
separately. One-step protocols are best suited to laboratories carrying out screening
of multiple samples for repetitive tests, or high-throughput screening.(12)
Multiplex RT-PCR is a variation of RT-PCR in which multiple targets are amplified

simultaneously, facilitating the detection of numerous targets in a single reaction.(13)
This can translate to increased efficiency, yielding more data from each reaction and
using fewer reagents. However, efficient multiplex reactions are difficult to design as
assay conditions must be optimised to detect all targets equally.(13) A number of
multiplex RT-PCR tests have been CE-marked for use in the EU.
Newer, real-time RT-PCR-based near-patient IVD tests that incorporate nucleic

acid extraction, amplification and detection together into an integrated and sealed
cartridge processing have been developed (Figure 1, C and D).(10) These rapid PCR
devices increase the speed and convenience of PCR to support timely and accurate
diagnosis. However, these near-patient tests are not currently available in Ireland,
nor are they suitable for high-throughput testing.
Other molecular methods – isothermal amplification
By obviating the need for thermal cycling, isothermal amplification methods are
simpler and faster to perform than RT-PCR, making them more suitable for resource-
limited or near-patient testing applications. The RNA-targeting clustered regularly
interspaced short palindromic repeats (CRISPR) associated enzyme Cas13 has
recently been adapted for the isolation of gene segments for diagnostics using gene
editing techniques.(7, 14, 15) Zhang et al. first reported a CRISPR-based nucleic acid
detection technique called SHERLOCK (Specific High Sensitivity Enzymatic Reporter
UnLOCKing) for the detection of SARS-Cov-2 nucleic acids.(7) A recently developed
assay, SARS-CoV-2 DETECTR, is reported to have comparable accuracy to real-time
RT-PCR. Methods using CRISPR Cas12 systems are in development, but are not
currently used in a clinical setting.(14, 16)
Loop-mediated isothermal amplification (LAMP) detects viral nucleic acid through

RNA amplification using four-to-six specially designed primers and a DNA polymerase
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with chain displacement activity under a constant temperature (60-65°C).(17) LAMP

can be combined with reverse transcription (i.e., RT-LAMP), where both reverse
transcription and amplification occur simultaneously allowing the direct detection of
RNA.(17) This system, can be coupled with a colorimetric indicator present in the
reaction mix allowing readout of the amplification reaction and diagnosis based on
an observed colour change. The diagnostic test accuracy of RT-LAMP based methods
are reported to be similar to RT-PCR.(18) The technique is said to be highly specific as
recognition of multiple conserved regions is required. RT-LAMP is a faster and more
convenient method for SARS-CoV-2 RNA detection requiring fewer laboratory
resources and has the potential to extend the capacity of laboratories to process 2.5
more clinical samples relative to qRT-PCR.(19) No CE-marked RT-LAMP technologies
have been identified, although a number are reported to be in development.
Genetic sequencing
Genome sequencing was used primarily in the early days of the outbreak for initial
identification of the novel virus and is largely a tool of viral discovery.(6) Now that the
complete genome sequence of SARS-CoV-2 has been obtained, most sequencing is
being undertaken to characterise the virus and monitor for viral mutation, not for
clinical diagnosis.(6) Characterising the virus and genomic surveillance can be used
by public health authorities to understand the genetic determinants of viral
transmission, infectivity and virulence.
As SARS-CoV-2 has not previously been identified in humans, there is no acquired

immunity to the virus within the population. Genomic surveillance will be useful in
determining the genomic stability of SARS-CoV-2 and the likelihood that antibodies
generated against the virus through exposure will provide protection against re-
infection in the future. In response to the host immune response, selective pressure
on the virus may result in antigenic drift over extended periods of time. Ongoing
genomic surveillance will be important in monitoring for the appearance of
selectively advantageous mutations. Viral genome sequences could also inform the
development of treatments and vaccines.
2.3.2. Antigen detection tests
Immunoassays can be used to detect the presence of proteins in clinical samples.

Detection of viral protein (termed antigen assays) indicates the presence of viral
infections.(20) Immunoassays are available in a wide range of different formats, but
essentially consist of an antigen or antibody, immobilised on a surface, which binds
virus-specific antigens or antibodies from a patient sample (for example, sputum or
blood sera). By adding a further reporter protein, it is then possible to detect a virus-
specific immune signal to confirm the presence of the antigen or antibody.(20, 21)
Binding assays such as immunofluorescence assays (IFAs) and enzyme-linked
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immunosorbent assays (ELISAs) could be used for the diagnosis of SARS-CoV-2.(22,

23)
Antigen detection is well established in the investigation of some infections where

diagnostic methods have evolved over decades (for example, hepatitis B virus),
notably where it allows active infection to be differentiated from a vaccine-induced
antibody response.(24) Assays which combine detection of antigen and or antibody
allow earlier diagnosis of infection than assays detecting antibody alone, reducing
the diagnostic window. This approach is in routine use for the diagnosis of viral
infections such as HIV, where diagnostic approaches have evolved over decades.(25)
Antigen detection tests detect virus-specific antigens by using antibodies developed

in the laboratory (the antibody does not come from the patient). The tests can
detect the presence of infection during the acute stage of infection and could
potentially be used in addition to current RT-PCR-based testing. They have a faster
turnaround time, and are easier to operate relative to RT-PCR; however, they
generally are less accurate.(26)
Antigen detection assays, if proven to have high sensitivity and specificity may be of
value in the diagnosis of COVID-19 infection.
2.3.3. Viral culture
SARS-CoV-2 can be isolated from clinical samples through viral culture, but is not
recommended as a routine diagnostic procedure.(4)
2.3.4. Microarray or microfluidic lab-on-chip technologies for the
detection of viral RNA or antigens
New techniques such as high-density nucleic acid arrays, also known as microarrays
or chips, are miniaturised devices, which comprise small flat surfaces, onto which
ordered arrangements of individual samples are positioned, allowing simultaneous
detection and identification of multiple viruses in a single clinical sample.(27, 28)
Microarray-based methods allow the use of smaller sample volumes, more efficient
analyses and higher throughput.(7) In clinical diagnostics, microarray technology can
be used to differentiate between COVID-19 and other respiratory infections that
have similar symptoms. Microarray technology for the detection of SARS-CoV-2 in
addition to other common human respiratory pathogens are in development.
Microfluidics devices perform chemical analyses of extremely small volumes of fluids
such as blood. The main advantage of microfluidic technologies is less sample and
reagent consumption, in addition to their potential use as near-patient devices.
Microfluidic systems have been used for the detection of other coronaviruses and are
currently in development for the detection of SARS-CoV-2.(29)
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2.4. Detection of immune response

2.4.1. Antibody tests
Humoral immunity refers to the production of antibodies in response to the presence

of antigens in the blood or extracellular fluid. Antibody tests can therefore be used
to detect past exposure to SARS-CoV-2. However, it typically takes the body a
number of days to mount a response to the infection, so the utility of antibody tests
for diagnosing acute infections in the early stages of the disease is limited. A positive
test can indicate current or resolved infection; however, as noted, negative results
do not exclude SARS-CoV-2 infection, particularly among those with recent exposure
to the virus.
Antibodies against common human coronaviruses are prevalent in the population.

Whole genome sequencing has shown that SARS-CoV-2 shares a high degree of
nucleotide identity with SARS-CoV–2.(9) Thus, any antibody tests to detect SARS-
CoV-2 needs to identify and rule out cross-reactivity with these common human
coronavirus strains.(22)
Antibody-based methods detect the presence of IgG and IgM antibodies specific to
SARS-CoV-2 in clinical samples. During the primary response to a virus, IgM
antibodies are the first to appear, but are relatively short-lived and disappear after a
number of weeks. The detection of IgM antibodies might imply recent or potentially
active infection. IgG is the major antibody of the immune response and may provide
long-lasting immunity against re-infection with the same virus.(30) While some
studies have reported detection of antibodies three days after the onset of
symptoms using antibody assays,(31) such tests may not be reliable in the early
phase of infection and should not be used for case detection in patients with
clinically suspected COVID-19 according to WHO guidance.(4) For the diagnosis of
acute infections, there is considerable lag period as antibodies specifically targeting
the virus typically appear seven to 14 days after illness onset.(32) Antibody
production may be delayed, weak or ineffective in the elderly and in those who are
immunocompromised as a result of disease, immunosuppression or other treatments
which weaken the immune response, such as chemotherapy.
Immunoassays are typically easier to operate and have faster turnaround times
compared with RT-PCR; however, in general, this is at the expense of diagnostic test
accuracy.
2.4.2. Microarray or microfluidic technology for the detection of
antibodies
The development of protein chip or microarray technology could provide a sensitive,

high-throughput method for diagnosis of COVID-19 by facilitating detection of SARS-
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CoV-2 antibodies in patient samples. The patient sample (for example, serum) is
incubated on the chip. If SARS-CoV-2 antibodies are present in the sample, the
interaction between the antibody and its target antigen is detected.(33)
Proteome microarrays for the detection of SARS-CoV-2 are currently in development

and could be used to identify, profile, and compare specific antibody responses in
patient sera to inform vaccine development, or screen viral antigens to find and
characterise immunodominant epitopes for in-vitro diagnostics research.(34, 35)
2.5. Rapid tests
Rapid tests are defined under the common technical specifications for IVDs as
qualitative or semi-quantitative in vitro diagnostic medical devices, used singly or in
a small series, which involve non-automated procedures and have been designed to
give a fast result.(36) Rapid tests are intended for use in resource-constrained or
near-patient settings, with their use restricted to the setting for which CE marking
was received. While other commercial CE-marked tests automated for use on
analyser machines are available in portable equipment form and provide fast results,
they do not fall under the above definition of rapid tests.
In February 2020, a WHO expert group identified accelerated research into rapid
tests as one of eight key actions necessary to the control the COVID-19
emergency.(37) Many of the rapid tests available and in development for the
detection of SARS-CoV-2 are based on antigen and antibody immunoassays. The
majority of rapid tests are based on lateral flow assays, cellulose-based devices
intended to detect the presence of a target analyte in a liquid sample.(38) As
highlighted previously, with antibody and antigen-based tests there is a potential for
cross-reactivity to proteins common to other types of coronavirus. Reliable measures
of the diagnostic test accuracy of newly developed tests will require independent
validation studies.(22)
Rapid tests based on isothermal nucleic acid amplification that can provide timely
results to clinicians have also been developed. At least one test has been approved
under an emergency use authorization (EUA) in the US and commercialised. While
not yet CE-marked, this test is undergoing independent validation testing in Ireland.
The test, which can provide results within 45 minutes, leverages off an existing
cartridge technology in which multiple regions of the viral genome are targeted. It is
designed for use on a platform that has already been deployed in a number of
hospitals.(39)
Technological advancements in immunoassays are not necessarily in the

methodology of the assay, but rather the instrumentation used to interpret the
results. Results obtained through visual inspection are less sensitive and subject to
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inter-operator variability. The use of digital readers allows a lower limit of detection
than can be achieved with manual interpretation of the assay and increases the
reproducibility of results. However, digital immunoassays require increased operator
handling, and the availability of the assay reader wherever the test is carried out.(40)
2.6. Selection and interpretation of tests
Selection of the most appropriate testing strategy will depend on the local
epidemiological situation and the availability of resources. The ASSURED (Affordable,
Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable
to end-users) criteria proposed by the WHO can be used as an indicator of the most
appropriate diagnostic test(s) among available testing alternatives in resource-
constrained settings.(41) While efforts are underway increase diagnostic testing
capacity for SARS-CoV-2, selection of the most appropriate test is challenging for
policy-makers, laboratories and other end users given the current global shortage of
laboratory consumables and reagents, and limited independent test validation data
for. The selection and interpretation of tests is discussed further in Section 3
(international approaches) and Section 4 (operational utility) of this assessment.
Real-time RT-PCR is the gold standard for diagnosing suspected cases of COVID-19.
Notwithstanding this, it is noted that negative test results do not preclude SARS-
CoV-2 infection and cannot be used as the sole basis for patient management
decisions. There may be a number of explanations for apparent discordance
between test results and clinical findings, some of which are unrelated to the test
itself. Firstly, there is a potential for pre-analytical errors including issues such as
insufficient sampling, contamination of specimens, and inappropriate storage and
transport conditions. Secondly, the analytical process can effect results due to
operator error or the use of different sample preparations. Thirdly, the viral
dynamics of SARS-CoV-2 across the time course of the infection are still not fully
understood. Hence, false negative test results may occur if samples are tested
during the early incubation period or else during the late convalescent phase, when
virus levels may be undetectable. Differences in viral dynamics over the course of an
infection may also contribute to discordance between test results based on different
specimens (upper versus lower respiratory tract).
Testing in accordance with the principles of good laboratory practices and quality
assurance programmes for clinical laboratory testing will minimise the risk of false
negative or false positive results. This includes application of appropriate assay
controls that identify poor-quality samples can help to avoid many false-negative
results as a result of improper collection, storage and handling procedures.
In relation to the RT-PCR test, there may be differences in primers and probes used
in the protocols underpinning the RT-PCR methods that impact analytical sensitivity
Page 29 of 121
and specificity, while different laboratories and devices may use different threshold
values to determine positive, negative and indeterminate test results, which may
lead to false-negative results as samples may be interpreted slightly differently.(42, 43)
Improvements in RT-PCR tests are ongoing to enable better detection at lower levels
of RNA.
Page 30 of 121
Table 2.1 Characteristics of alternative diagnostic tests for SARS-CoV-2
Method Use Suggested advantages Suggested Estimated Potential use(s)

limitations/challenges time*
CE-marked and commercially available
RT-PCR Detection of viral RNA  Accurate  Requires specialised Reaction time:  Detection of active infection
 Widely available laboratory equipment and 4-6 hours  Multiplex RT-PCR can be used
 Gold standard technique facilities minimum for differential diagnosis
 Well established technology  Requires skilled analysts
 Multiple clinical applications  Cannot identify those who Turnaround
(e.g. diagnostics, screening, have cleared the infection time: 24
treatment decisions,  May not recognise viral hours(44)
monitoring of response to mutations
treatment).  Requires high purity
 Validated protocols available samples
 Misclassification errors can
occur due to the timing or
site of sampling
Microfluidic Perform chemical  Less sample and reagents  Newer technology Reaction time:  May be suitable for near-patient
assays analyses on small consumption than RT-PCR  Not independently 40 minutes testing or resource-constrained
volumes of fluids e.g.  Potential to analyse more validated settings
blood pathogens within a single test
(e.g., respiratory panels)
Antibody tests Detection of IgG or IgM  Identify those who have  Antibody response may Reaction time:  Seroepidemiological studies
antibodies. previously been infected not be seen for 8-10 days, 2-30 minutes  Inform public health measures
 Rapid tests (turnaround < 30 so not suitable for to limit virus spread
minutes) available identifying active infection  De-escalation of care for
 Potential for cross hospitalised patients
reactivity with other  Redeployment of healthcare or
viruses other essential workers
 Can be used for near-patient
testing
Antigen Identification of viral  Faster turnaround time  Less accurate and reliable Reaction time:  Identification of active infection
detection tests proteins compared with RT-PCR compared with RT-PCR 10 minutes.  Triaging of patients
 Relieve pressure on  Variation in performance  Can be used for near-patient
laboratories between devices testing
 Antigens are more stable than
RNA
Page 31 of 121
Method Use Suggested advantages Suggested Estimated Potential use(s)

limitations/challenges time*
Available for research use only
Whole genome Characterisation of the  Understand the spread of the  Costly Turnaround  Virus characterisation
sequencing viral genome virus  Time-consuming time: 7  Research and genomic
hours(45) surveillance
 Understanding viral transmission
and pathogenicity
 Identification of viral mutations
 Inform treatment development
In development
CRISPR Gene editing  Accurate  Newer technology - not Reaction time:  Detection of active infection
technology  Fast yet independently 30 - 60  Near-patient and lab-based
validated. minutes(14-16) applications
Isothermal Detection of viral RNA  Faster than RT-PCR  Requires heat block/water Reaction time:  Detection of active infection
nucleic acid  Accurate bath/incubator for 40 minutes(17-  Suitable for resource-
amplification  Simpler and cheaper isothermal amplification of 19, 46-49) constrained settings
technologies instrumentation RNA.
e.g. RT-LAMP  More robust to inhibitors  Newer method - not yet
present in some sample independently validated.
preparations than RT-PCR
(i.e. less stringent sample
processing is necessary)
Microarray Detection of multiple  Test for the presence of  Reaction time means it Turnaround  National centres for infectious
assays viral components (e.g. multiple common human cannot be used to inform time: 2-5 disease control
RNA or protein) respiratory viruses and rapid clinical decision- hours(50, 51)  Differential diagnosis
simultaneously bacteria simultaneously making  Rule-out bacterial infection or
 Medium to high throughput  Target viral sequences co-infection with other viruses
 Less sample and reagent must be specific to each  Confirmation of results from
consumption than RT-PCR viral strain to prevent rapid tests
 Fewer operational cross-hybridization to
requirements than RT-PCR multiple related genome
 Reduced cost per reaction sequences
Page 32 of 121
Key: CRISPR - targeting clustered regularly interspaced short palindromic repeats; IgG – immunoglobulin G; IgM - immunoglobulin M; RNA - ribonucleic
acid; RT-LAMP – reverse transcription loop-mediated isothermal amplification; RT-PCR - reverse transcription polymerase chain reaction.
Notes: *Estimated reaction times (i.e. the length of time required to carry out a test excluding sample preparation) and turnaround times (i.e. the length of time between
receipt of the sample in the laboratory to reporting of the result) are based on manufacturer data from CE-marked tests, where available. For newer technologies, estimates
are based on tests in development or results from pre-print studies.
Page 33 of 121
3. International approaches to diagnostic testing
Key points
 The WHO, ECDC, and the CDC in the US recommend using laboratory-based
nucleic acid amplification (molecular) tests (manual or automated) to detect
SARS-CoV-2 RNA in clinical specimens (as of 14 April 2020). The same
molecular approach has been recommended for use to detect acute infection
with SARS-CoV-2 in Ireland and the UK, among other countries.
 The ECDC recommends that a serum sample should be collected and stored
during the acute phase of illness (that is, after symptom onset), and again
two to four weeks later, during the convalescent phase, to gain a better
understanding of disease course; for example, time to seroconversion and
subsequent viral clearance.
 The WHO has advised against the use of rapid diagnostic tests based on
antigen detection and host antibody detection in any setting (except research
settings), including for decision-making, until evidence supporting their use
for specific indications is available.
 Microfluidic lab-on-chip technologies and full genetic sequencing do not

appear to be used in any country for the detection of COVID-19. Although not
yet CE-marked, a microarray respiratory panel incorporating SARS-CoV-2 is
reported to be in use in the UK. While CRISPR is a gene-editing technology,
because of technical similarities in the process, a number of CRISPR
laboratories are reported to have repurposed their resources to provide
additional COVID-19 testing capacity during this pandemic.
A brief scoping review was undertaken to identify the diagnostic approaches being
recommended internationally. Included in the review were international agencies
and a limited number of European and non-European countries. This section
presents the findings from the review.
3.1 International guidance
A summary of the international guidance on testing is provided in Table 3.1. As of

April 1 2020, the WHO,(52) ECDC,(53) and the CDC in the US(54) recommend using
laboratory-based nucleic acid amplification (molecular) tests (manual or automated)
to detect SARS-CoV-2 RNA in clinical specimens. In each case, the recommended
approach to testing is broadly consistent. A sample from the upper and or lower
Page 34 of 121
respiratory tract is taken using a nasopharyngeal or oropharyngeal specimen (upper

respiratory tract), often using the same swab, and or endotracheal, bronchoalveolar
or sputum specimen (lower respiratory tract). A nucleic acid amplification test, or
RT-PCR, is then used to identify the RNA specific to SARS-CoV-2 that cause COVID-
19. In Ireland(55) and the UK,(56) among other countries,(57-59) the same molecular
approach has been recommended for use to detect COVID-19. As of 11 April 2020,
Spain has also issued guidance on which samples (that is, upper or lower respiratory
tract) should be used for the diagnosis of COVID-19 by rapid antigen testing,
although it is unclear whether the test is routinely used in practice.
Although an increasing number of alternative diagnostic tests are being developed

and commercialised, there remains considerable uncertainty regarding the clinical
performance of these tests, in particular rapid tests such as direct SARS-CoV-2
antigen detection and indirect antibody detection tests. The limitations of rapid
diagnostic tests are being assessed by WHO referral laboratories and in clinical
studies funded by the European Commission and EU member states.(36) The WHO
has advised against the use of rapid diagnostic tests based on antigen detection and
host antibody detection in any setting (except research settings), including for
decision-making, until evidence supporting their use for specific indications is
available.(60) The WHO and ECDC have noted that they will update their guidance on
testing once there are sufficient data to validate the accuracy of the tests, including
guidance on when they should be deployed in the clinical pathway.(36)
While the use of alternative diagnostic testing to RT-PCR approaches remains to be

endorsed by the WHO and ECDC, or to the best of our knowledge at a national level
by any country, there has been a shift in guidance towards additional testing
pending the availability of validated tests. The ECDC,(53) along with many countries,
including Australia,(58) Germany,(59) Spain,(57) and the UK,(56) recommend collecting
serum samples for later detection of antibodies to SARS-CoV-2, once validated
serological assays are available (Table 3.1). The ECDC recommends that a serum
sample should be collected and stored during the acute phase of illness (that is,
after symptom onset), and again two to four weeks later, during the convalescent
phase. In order to gain a better understanding of the disease course, these data will
be particularly helpful in determining the time to seroconversion.(61)
Seroprevalence data could help to identify the level of population immunity, and
inform the allocation of scarce resources to prevent or manage transmission. On a
larger scale, serological testing plays an important role in determining the extent of
viral spread in the community. A proportion of the population may already be
immune due to mild or asymptomatic infections. In this way, serological testing
could inform practical issues, such as whether it is appropriate to re-open schools
and non-essential services closed to limit community transmission of the virus, or
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allow healthcare workers, along with non-healthcare workers, to return to work.

However, such an approach would be resource-intensive. Section 4 elaborates on
the issues associated with serological testing in practice.
Microfluidic lab-on-chip technologies and genetic sequencing do not appear to be
used at a national level in any country for the detection of COVID-19. Although not
yet CE-marked, a microarray respiratory panel incorporating SARS-CoV-2 is reported
to be in use in the UK. CRISPR is a gene-editing technology, which in recent years
has also been used for the in vitro detection of nucleic acids. However, diagnostic
tests employing CRISPR are as yet still only in the development phase. Because of
technical similarities in the process, a number of CRISPR laboratories are reported to
have repurposed their resources to provide additional COVID-19 testing capacity
during this pandemic. However, as indicated in Section 2.4.1, genome sequencing is
only useful during the early days of an outbreak. In the UK, the COVID-19 Genomics
UK Consortium, comprising the NHS, Public Health England, UKRI, and Wellcome
has been launched to track viral spread and evolution via genome sequencing of
SARS-CoV-2 samples.(62) Samples from patients with confirmed cases of COVID-19
will be sent to a network of sequencing centres in order to monitor changes in the
virus at a national scale to understand how the virus is spreading and whether
different strains are emerging.(17)
While RT-PCR remains the primary test for the detection of SARS-CoV-2
internationally, there has been a number of recent developments in relation to the
development and use of alternative diagnostic testing approaches to detect the
virus, as discussed below.
3.2 Recent international developments in diagnostic testing
A substantial number of RT-PCR detection kits have been authorised for use and
commercialised internationally. An advantage of using these test kits, in particular
rapid PCR detection kits, is that they can increase the speed and convenience of PCR
to support timely and accurate diagnosis of COVID-19. Use of these tests also
provides an opportunity to optimise and expand testing if deployed in laboratory
settings where they can leverage off existing laboratory resources such as reagents,
primer sequences, and automated systems. Some rapid PCR-based test kits have
also been developed and can be deployed near the point-of care with minimal
training required; however, these kits do not have the same capacity, or throughput,
as laboratory-based test kits. They are also not yet currently available in Ireland, to
the best of our knowledge.
Given the large number of rapid tests (and in particular rapid antibody tests) that
have been commercialised for use, it is likely that there has been some uptake and
use of these alternate tests. The settings and context in which they are being used
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is, however, uncertain. In the UK, it has been reported that rapid antibody tests will
be rolled out, alongside rapid antigen tests, to address the next phase of the COVID-
19 pandemic.(63) On April 9 2020, the Medicines and Healthcare products Regulatory
Authority (MHRA) in the UK published specification criteria for serology near-patient
tests and self-tests.(64) These criteria outline the minimally (and sometimes
preferred) clinically acceptable specifications for SARS-CoV-2 tests to be used in the
UK during the COVID-19 pandemic, highlighting that use of lower specification test
kits would likely provide no clinical benefit and could lead to increased harm. Public
Health England currently advises against the use of these tests in community
settings, such as pharmacies, or at home due to the lack of evidence on the
suitability of the tests to detect COVID-19 in these settings.(65) The Health Products
Regulatory Authority (HPRA) in Ireland has also advised the public against the
purchase of diagnostic test kits online or from any retailer after it became aware of
falsified test kits being sold in Europe.(66)
On 15 April 2020, the European Commission issued guidelines on COVID-19 IVD

tests and their performance.(67) The Commission subsequently published a working
document that provides additional guidance to the legally obligatory requirements
defined in the IVDR.(68) Based on the principles of good analytical (testing) practice,
and making the distinction between a tests analytical performance (that is, the
ability of the test to detect a marker of interest) and its clinical performance (that is,
the ability of a test to determine a patient’s clinical status). These guidelines include
performance criteria for RT-PCR, antigen-based and antibody-based tests. The
current absence of control samples and reference materials are noted as a particular
challenge to establishing the diagnostic test accuracy of antigen and antibody
tests.(68) The Commission has also established a European taskforce comprising
representatives of the European Commission’s Joint Research Centre (JRC), ECDC,
HTA experts and IVD experts. This taskforce is aimed at supporting the JRC in
completing a rapid review of the performance of IVD test methods and devices for
the assessment of COVID-19 and to make recommendations regarding same.(67)
While common technical specifications (CTS) exist for a number of blood tests (blood
grouping tests, HIV tests), as yet no such CTS exist for COVID-19.(69)
While antibody testing is unsuited to the detection of acute infection, it has been
suggested that targeted antibody testing could provide key data for efforts to model
the course of the pandemic and the necessary public health response. If validated
antibody tests were available, there is speculation that they could be used to enable
rollout of so-called immunity passports that would enable social restrictions to be
lifted and inform staff redeployment. There are anecdotal reports that a number of
healthcare organisations in the US have commenced, or plan to roll out, antibody
testing to inform deployment of healthcare staff. A number of these institutions have
internally developed tests that have undergone rigorous internal verification to
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ensure their accuracy.(70) There are also anecdotal reports that antibody testing to
inform deployment of healthcare staff has commenced in two regions in Italy. In
Germany, the Helmholtz Centre for Infection Research (HZI) is coordinating a study
to determine if there is unidentified COVID-19 immunity in the population using
antibody tests. Over 100,000 subjects are to participate in the population study
which will provide greater insights into the extent of viral spread and potential
immunity in the population.(71) Of note, immunity passports are not used for any
other respiratory virus, so their role in SARS-CoV-2 remains theoretical for now.
A number of clinical trials are underway internationally to address potential immunity

in the population,(72) along with time to seroconversion,(73) which could also provide
key data for efforts to model the course of the pandemic in the future. However, the
majority of these trials are collecting serum samples for the later detection of
COVID-19, once serological testing has been validated.
3.3 Discussion
Internationally, real-time RT-PCR remains the primary recommended test for the
detection of the SARS-CoV-2 virus. A range of alternative diagnostic testing
approaches have been developed to detect either the virus or the body’s immune
response to the virus. These include a range of laboratory-based and rapid tests
designed for near-patient testing; however, the majority of these are yet to be
validated for use in clinical settings. As of 8 April 2020, the WHO has strongly
advised against the use of rapid diagnostic tests based on antigen detection and
host antibody detection in any setting, except research settings, until the evidence
base is sufficient to justify their use.
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Table 3.1 Testing approaches for SARS-CoV-2 by organisation and country

Organisation Primary SARS- Sample(s) Specimen(s) Additional tests for SARS-CoV-2
/ country CoV-2 test
WHO(52) Nucleic acid  Upper respiratory tract sample  Upper (ambulatory patients): Suggests the use of nucleic acid
19/03/2020 amplification test and/or lower respiratory tract - nasopharyngeal and oropharyngeal swabs sequencing for confirmation of cases
sample - nasopharyngeal wash/aspirate of COVID-19 when necessary
 Lower (patients with more severe respiratory
disease):
- sputum
- aspirate
- lavage
CDC(54) Nucleic acid  Upper respiratory tract sample Nasopharyngeal swab (recommended) Also recommends using lower
14/04/2020 amplification test If this is not possible: respiratory tract specimens, if
 Nasal mid-turbinate (NMT) swab (using a flocked available, including sputum. When it
tapered swab); is clinically indicated (e.g., those
 Anterior nares specimen (using a flocked or spun receiving invasive mechanical
polyester swab) ventilation) a lower respiratory tract
using aspirate or bronchoalveolar
lavage sample is recommended
ECDC(53) Nucleic acid  Upper respiratory tract sample;  Upper: If resources allow, a single positive
08/02/2020 amplification test  Lower respiratory tract sample - Nasopharyngeal swab test should be confirmed by a second
if the patient is hospitalised or - Oropharyngeal swab RT-PCR assay targeting a different
in intensive care - Nasopharyngeal wash/aspirate. SARS-CoV-2 gene. If the result of the
 Lower (if patient is hospitalised or in intensive first virus gene test is inconclusive or
care): weakly positive and there is a strong
- Bronchoalveolar suspicion for SARS-CoV-2 infection,
- Sputum another specimen should be tested
- Aspirate with the primary and secondary RT-
PCR assays.
Serum (to be stored pending

serology availability), acute and
convalescent (possibly 2 to 4 weeks
after acute phase), along with faeces
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Ireland(55) Nucleic acid  Upper respiratory tract sample;  Upper: None specified
20/03/2020 amplification test  Lower respiratory tract sample - Combined swab for oropharyngeal or
nasopharyngeal samples (one swab to test both
is sufficient) in ambulatory patients.
 Lower:
- Bronchoalveolar lavage OR Endotracheal
aspirate OR Sputum (if produced) is preferred in
cases of severe illness
UK(56) Nucleic acid  Upper respiratory tract;  Upper: A serum test should be collected if a
06/04/2020 amplification test  Lower respiratory tract - A viral nose swab AND a viral throat swab in patient is admitted to hospital. The
one collection tube OR sample should be collected at the
- single swab used for throat then nose in one same time as other samples collected
collection tube OR for primary diagnostic testing for
- A nasopharyngeal aspirate in a universal COVID-19
transport pot. Bacterial or charcoal swabs are not
suitable
 Lower:
- Sputum, if available
Australia(58) Nucleic acid  Upper respiratory tract sample;  Upper: Serum should be collected during the
01/04/2020 amplification test  Lower respiratory tract sample, - Deep nasal and oropharyngeal combined swab acute phase of the illness (preferably
where possible - Nasal wash/aspirate within the first 7 days of symptom
 Serum (to be stored pending  Lower (recommended where possible): onset), stored, and when serology
serology availability) - Bronchoalveolar lavage testing becomes available tested in
- Sputum parallel with convalescent sera
collected 3 or more weeks after
acute infection. If no acute sample
was collected, sera collected 14 or
more days after symptom onset may
be tested
Germany(59) Nucleic acid  Upper respiratory tract sample;  Upper respiratory tract: Serum samples should be collected
30/03/2020 amplification test  Lower respiratory tract sample, - Nasopharynx smear or lavage and preserved as early as possible in
where possible - Oropharynx smear the acute phase in order to check
 Lower: seroconversion for SARS-CoV-2 by
- Bronchoalveolar lavage pairing with convalescent serum
- Sputum (produced or induced according to
instructions ; observe occupational safety)
- Tracheal secretion
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Spain(57) Nucleic acid  Upper respiratory tract sample;  Upper: If possible, serum samples should be
11/04/2020 amplification test  Lower respiratory tract sample, - Nasopharyngeal swab (preferred) and/or taken at least 14-30 days apart, with
or rapid antigen where possible oropharyngeal swab the first serum collected in the first
test  Lower (if patient is hospitalised or in intensive week of illness(acute phase). If only
care): a single serum sample is collected, it
- Bronchoalveolar (preferred) and/or should be taken at least 14 days
- Aspirate after the onset of symptoms in order
to confirm the presence of specific
antibodies
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4. Operational utility
Key points
 Pathogen detection tests and tests aimed at detecting an immune response to

the virus should not be considered competing alternatives. Both testing
approaches are clinically relevant at different time points during the clinical
course of infection.
 Nucleic acid amplification-based (molecular) approaches for the detection of the

SARS-CoV-2 RNA are important for confirmation of acute viral infection early in
the clinical course of infection.
 Once validated rapid antigen tests, with sufficient sensitivity and specificity, are
available, they could be used alongside real-time RT-PCR in the acute phase of
infection, in circumstances where access to or turnaround times for laboratory-
based testing is inadequate and an early diagnosis if required to inform patient
care.
 The use of antibody tests is limited to later in the clinical course of infection or
following recovery to identify those who have been exposed to SARS-CoV-2.
Their use is contingent on the availability of validated tests with sufficient
sensitivity and specificity. As SARS-CoV-2 has not been previously identified in
humans, little is known regarding the adequacy of the immune response or the
duration of immunity following seroconversion, so it is not known if reinfection
can occur. The role of antibody testing is therefore limited outside of well-
constructed seroprevalence studies to model the course of the pandemic and
inform the public health response.
 The level(s) at which rapid antigen or antibody tests might be deployed has
important implications for both administration and reporting of tests as well as
the overall governance of any testing strategy.
 The currently agreed national testing strategy is outlined in the HSE pathway of
care for the assessment and management of COVID-19. This document is
routinely updated as the strategy evolves based on emerging evidence.
4.1 Introduction
This section summarises where available tests, and particularly:
 pathogen detection tests (to detect active infection with the SARS-CoV-2
virus)
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 tests to detect an immune response to the virus (that is, anti-SARS-CoV-2 IgG
and IgM antibodies that indicate past exposure to the virus),
could be deployed in the clinical pathway in the management of COVID-19.
Viral antigens and antibodies become detectable at different times during the clinical
course of infection (that is, from the presymptomatic/asymptomatic phase through
to full resolution of symptoms or death). While the exact time at which SARS-CoV-2
RNA, specific antigens, and IgG and IgM antibodies can be detected depends on
several factors, including the specific test used, individual patient variability and viral
characteristics. In general, the stages at which these markers of infection become
detectable can be estimated to inform the use of diagnostic tests. Information
regarding the optimal timing of tests measuring viral antigens or components of the
host immune response is vital to inform the optimal timing of requests for tests and
interpretation of test results.
In general, methods detecting the presence of the virus, and methods based on the
detection of the host immune response, are appropriate at different points in the
clinical course of infection for different clinical and public health applications. For the
purposes of this report, operational utility is used to describe the extent to which
application of a diagnostic test can produce clinical benefit by preventing or
improving adverse health outcomes through the detection of current or past SARS-
CoV-2 infection.
The diagnostic windows for the detection of acute SARS-CoV-2 infection (viral RNA)
and the immune response (anti-SARS-CoV-2 IgM and IgG) indicating past exposure
to SARS-CoV-2 are summarised in Figure 4.1. Where appropriate, evidence
generated as part of ‘evidence summaries’ compiled by HIQA to assist the Clinical
Expert Advisory Group supporting the NPHET in their response to COVID-19 has
been used to determine the operational utility of identified diagnostic testing
methods during the clinical course of disease (that is, from the pre-symptomatic
phase or early infection through to full resolution of symptoms).(74)
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Figure 4.1 Diagnostic windows for the detection of acute SARS-C0V-2 infection
(viral RNA) and the immune response (anti-SARS-CoV-2 IgM and IgG) indicating
past exposure to SARS-CoV-2
Note: *While the sequence of events is well understood, the exact timeline is based on early
evidence summaries and is subject to considerable uncertainty.
4.1. Methods of viral detection for acute infection
Early detection of cases is a priority to minimise COVID-19-associated morbidity and

mortality, initiate rapid and effective contact tracing and prevent further
transmission of the virus.
Using RT-PCR, SARS-CoV-2 viral RNA can be detected one-to-two days prior to
symptom onset in upper respiratory tract samples.(75) The evidence to date appears
to suggest that viral load throughout the duration of COVID-19 peaks around
symptom onset and decreases within one-to-three weeks.(74) Although the duration
of detection and the magnitude of the viral load, appears to vary from patient to
patient, there is evidence to suggest that the viral RNA becomes undetectable (from
upper respiratory tract specimens) approximately two weeks following symptom
onset.(76-90) Therefore, based on current data it is estimated that the infectious
period lasts for seven-12 days in moderate cases and up to two weeks on average in
severe cases.(91)
Other nucleic acid based approaches for the detection of SARS-CoV-2 nucleic acids
such as CRISPR/Cas12 and RT-LAMP-based methods have been reported to demonstrate
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comparable sensitivity and specificity in proof-of-principle studies to RT-PCR suggesting

that these assays may be most appropriately used early after symptom onset when viral
load is highest. However, further independent validation studies using clinical samples are
needed. (Figure 4.1). Antigen detection tests are also suitable for use at an earlier
stage in the clinical course of infection.(26)
Early case detection
Molecular methods (for example RT-PCR, isothermal amplification-based methods)

should be used for early detection of SARS-CoV-2 cases, where possible. In
circumstances where molecular-based testing methods are not immediately
available, validated antigen detection tests, if available, could be used in particular to
facilitate early diagnosis in patients at the highest risk of adverse clinical outcomes,
such as patients in intensive care units. However, negative results from antigen
detection tests should be followed up with RT-PCR testing to confirm the absence of
infection.
Patient discharge
There is some evidence to suggest that high serum viral loads may be associated
with more severe disease.(92, 93) In the early days of infection, serial monitoring of
the plasma viral load in COVID-19 patients with highly sensitive tests could be
considered to provide prognostic insights and facilitate treatment decisions, although
it is recognised that there are currently no specific medications to treat COVID-19. In
the context of limited reagents and personal protective equipment needed for
sample collection, in addition to an unmet demand for initial diagnostic tests, clinical
monitoring of patients based on viral RNA or antigen levels may not be feasible.
Where testing capacity permits, patients may be discharged based on clinical
resolution of symptoms, and evidence for viral RNA clearance from the upper
respiratory tract. However, the frequency of specimen collection may depend on
local epidemic characteristics and resources. Current guidance from the WHO
recommends that two consecutive negative results collected more than 24 hours
apart from a clinically recovered patient are needed prior to hospital discharge.(94)
Differential diagnosis
Multiplex PCR testing is of particular importance in immunocompromised patients in

whom co-infections are common and are associated with greater morbidity and
mortality compared with immunocompetent individuals.(95) The use of multiplex PCR
that test for the presence of multiple common human respiratory pathogens in
parallel can facilitate differential diagnosis and enable timely, appropriate treatments
to be initiated in selected patients.(96) While the current national emergency relates
to the COVID-19 pandemic, and early evidence indicates that CT findings in COVID-
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19 lung disease are highly suggestive of infection with SARS-CoV-2, it must be noted
that acute respiratory signs and symptoms are seldom specific for a single pathogen.
Ultimately, detection strategies that allow for multiple respiratory pathogens to be
simultaneously detected, may have a significant impact on infectious disease
management both from a patient and a public health perspective. The ability to
accurately rule in or out a respiratory pathogen particularly in cases of severe
infection leading to patient hospitalisation in the ICU supports optimised care and
therapy selection for the individual patient.
Syndromic respiratory infection testing is used for seasonal and sporadic outbreak
surveillance and preparedness and is routinely deployed as part of epidemiological
surveillance by national centres for infectious diseases control. While still in
development, multiplex PCR testing kits and microarray technology that also
incorporate SARS-CoV-2 in the test panel of common respiratory pathogens will be
required for the next influenza season to replace existing multiplex kits deployed in
the healthcare system.
Patient triage
In the context of reagent shortages and inadequate access to laboratory testing,

consideration could be given to the use of rapid antigen tests or rapid molecular
tests to accelerate clinical decision-making and to reduce the workload of centralised
testing laboratories. If accurate and validated tests become available, rapid tests, in
particular antigen detection tests, could be used to triage or screen patients in
healthcare settings.(97)
Prioritisation of case detection to reduce transmission
The agreed national testing strategy is outlined in the HSE pathway of care for the
assessment and management of COVID-19.(98) This document is routinely updated
as the strategy evolves based on emerging evidence. During the scaling-up of the
testing capacity, a gradual approach based on clearly established priorities is
necessary. Testing is prioritised for those most in need in order to minimise COVID-
19-associated morbidity and mortality. High priorities for testing include healthcare
workers, people with comorbidities, people in long-term care facilities and elderly
individuals. If there is sufficient capacity within the healthcare system, prioritisation
of testing may be expanded to holders of ‘essential jobs’ (such as social workers,
public transport, transportation and distribution of essential goods, first responders
etc.), and those for whom working-from-home is not an option.
Decentralised rapid antigen or rapid molecular testing could be performed in near-

patient or community settings without the need for specialised equipment. However,
the impact of near-patient testing on workflow processes in a particular setting
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requires careful consideration. Given the lower sensitivity of rapid antigen tests
relative to RT-PCR (that is higher risk of false negatives), it is assumed that such
tests should only be used to rule-in cases. That is, follow-up testing with RT-PCR or
comparable molecular methods would be required to confirm a negative test result
as it does not preclude SARS-CoV-2 infection and could not be used as the sole basis
for patient management decisions. The availability and diagnostic test accuracy of
CE-marked rapid antigen tests is discussed further in Sections 5 and 6. However, it is
of note that although a number of rapid antigen tests have been reported as CE-
marked, no data to support their independent validation has been identified.
Surveillance
Strategies for the surveillance of viral transmission are important to inform safe and
effective infection control measures. An Irish Epidemiological Modelling Advisory
Group has been established to inform public health measures in relation to COVID-
19. National level surveillance data could be used to support the group in modelling
the course of the pandemic. National level surveillance efforts are important for
ongoing monitoring of:
 the number of new cases, geographic spread, and severity of COVID-19 in

the population in order to estimate the burden of disease and assess the
direction of recent time trends
 the risk groups that are most affected
 the impact of the pandemic the healthcare system to predict the trajectory of
the pandemic curve and inform resource allocation
 the impact of any mitigation measures (for example, contact tracing, social
distancing) to inform adjustments to the timing and intensity of infection
control measures
 outbreaks in hospitals or long-term care facilities to protect healthcare

workers and patients.
Data on those diagnosed with SARS-CoV-2 infection in Ireland is captured by current
surveillance systems in Ireland. As testing capacity expands, more comprehensive
estimates of viral transmission will become available.
Sentinel syndromic surveillance refers to monitoring of rate of occurrence of specific

conditions in selected, targeted groups or networks (that is, sentinels) to estimate
population-level incidence rates and trends. The ECDC has recommended that
COVID-19 surveillance should be integrated with existing sentinel surveillance of
influenza-like illness (ILI) or acute respiratory infection (ARI).(99) Where feasible, it
has been suggested that these sentinel surveillance systems should be expanded to
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include more physicians and thus improve population coverage to obtain more
comprehensive estimates.(99) It is not yet known if SARS-CoV-2 will follow the
traditional respiratory season with a decrease in the late spring and summer.
Therefore it has been suggested that sentinel surveillance should be extended
beyond the end of the influenza season in order to generate data in relation to
COVID-19.(99)
Virological sentinel surveillance of COVID-19 should be based on the clinical

specimens obtained through national sentinel surveillance of influenza-like illness /
severe acute respiratory infections (ILI /SARI). Representative stains with associated
geographic, demographic (for example, age, sex, comorbidities), clinical (such as
disease severity) and temporal data should be selected for sequencing in order to
monitor genetic changes in the virus that could alter the virulence of the virus or
sensitivity to diagnostic tests.(99)
4.2. Methods detecting the host immune response
Antibody testing is dependent on the host’s immune response to infection. The

length of time this takes will depend on factors such as the severity of infection and
the ability of the host’s immune system to respond to infection. Therefore, antibody
tests cannot be used to identify cases during the acute phase of infection. The
timing of seroconversion for SARS-CoV-2 is said to be similar to or slightly earlier
than in SARS-CoV infection.(80, 100) SARS-COV-2 IgG or IgM antibodies have been
reported to become detectable at approximately 10 days after the onset of illness.(86,
101) However, seroconversion has been reported to occur at day six or seven after
symptom onset in some cases.(85, 87) Larger studies have also indicated that for the
majority of patients, seroconversion more typically occurs after day 10 (Figure
4.1).(102, 103)
As noted in Section 3, following rigorous internal verification to ensure their

accuracy, a number of countries and providers are using laboratory-based antibody
tests to inform decision-making. In the context of inadequate access to laboratory
testing, rapid antibody tests may be used to reduce workload on centralised testing
laboratories. In contrast to rapid antigen tests to detect active infection where the
risk of a false negative test is of greater importance, the specificity of rapid antibody
tests is critical, as a false-positive result could provide incorrect assurance that an
individual is immune to SARS-CoV-2. The availability and diagnostic test accuracy of
rapid antibody tests is discussed further in Sections 5 and 6. However, it is noted
here that, while a large number of rapid antibody tests have been reported as CE-
marked, no data to support their independent validation has been identified. None of
the available CE-marked antibody tests are approved for self-testing.
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Targeted antibody testing could provide key data for efforts to model the course of
the pandemic and the necessary public health response. The operational utility of
antibody testing can be considered in the context of three potential scenarios:
 Patient level testing to inform clinical management
 Cohort studies to inform staff deployment
 Population level seroepidemiological studies to inform public health strategies.
The level(s) at which such testing might be deployed has important implications for
both administration and reporting of tests as well as well as the overall governance
of any testing strategy.
Patient-level testing
It has been suggested that antibody testing could be used to inform the
management of patients diagnosed with COVID-19. Current guidelines from the
WHO recommend collection of both acute and convalescent serum samples from
patients for serological testing, which can support the identification of the immune
response to a specific viral antigen.(4) Decisions to de-escalate care for patients
hospitalised with COVID-19 patients could be informed by antibody testing to
document IgG antibody specific to SARS-CoV-2 in addition to evidence of viral
clearance and clinical improvement.
The use of testing to inform the care and management of an individual patient,
should be conducted in accordance with routine administration and governance
arrangements. That is, the testing, reporting and follow up remain the responsibility
of the patient’s healthcare provider.
Cohort studies to inform staff deployment
Given the current international emergency in terms of the COIVD-19 pandemic, it

has been suggested that testing of individuals with suspected past exposure to
SARS-CoV-2 could be used to inform staff redeployment and or allocation of staff
resources.(61) As noted in Section 3, it has been suggested that immunity passports
could be issued to those with evidence of a sufficient acquired immune response to
inform the eligibility of staff to return to work. It has also been suggested that, in
the context of healthcare workers, these staff could be preferentially employed in
high-risk areas as they would not be considered at risk of contracting or spreading
the disease.(61) While neither of these approaches have previously been adopted, the
approach is in line with routine occupational health requirements that healthcare
workers have evidence of immunity to specified infectious diseases for which
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vaccines are available (for example, MMR, Hepatitis B virus) before they can engage
in direct patient care.(104)
There are a number of issues to consider with the use of antibody test results to
inform allocation of staff resources. As indicated in Figure 4.1, there is a window
during which an individual could have a positive RT-PCR test indicating ongoing
acute infection and a positive antibody test indicating an immune response has been
mounted. To mitigate the risk of transmission to others, laboratory confirmation of
viral clearance (for example, two negative RT-PCR tests at least 24 hours apart) or
an adequate time period since RT-PCR confirmation of an acute infection (current
guidelines suggest a minimum of 14 days, including five days with no symptoms if
applicable) would be required.(94)
For individuals without laboratory-confirmation of acute infection, but for whom

SARS-CoV-2 infection was suspected (for example, individuals who did not meet
criteria for priority testing or who did not present for testing), again consideration
must be given to ensure that sufficient time has elapsed since the presumed
exposure and or a requirement for RT-PCR confirmation to exclude acute infection
prior to returning to work. False positive test results may incorrectly classify
healthcare workers as immune to infection with SARS-CoV-2 placing them at risk of
contracting the infection. The specificity of antibody tests for SARS-CoV-2 is an
important consideration in circumstances where the test is used to inform staff
redeployment. As SARS-CoV-2 has not been previously identified in humans, little is
known regarding the adequacy of the immune response or the duration of immunity
following seroconversion. Therefore, it is not known if reinfection can occur. As with
the influenza virus, there is potential for antigenic drift and thus the potential that
immunity is limited to the initial strain of the virus.
From an operational perspective, consideration for the deployment and governance

of such an approach should include details of who is responsible for:
 providing the antibody test and in what setting it will be provided
 decision-making in relation to staff redeployment
 follow-up of the individual to ensure immunity in the context of an ongoing

pandemic or evidence of the emergence of new strains of the virus.
How, where and by whom any testing to inform staff redeployment is implemented
could also have important implications for how the veracity of an individual’s test
result is ensured given the financial imperative for many individuals to return to
work.
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Population-level seroepidemiological studies to inform public health

strategies
Well-constructed seroepidemiological studies could provide important information

on:
 age-specific and cumulative incidence rates of infection
 prevalence of cross-reactive antibodies to SARS-CoV-2
 the clinical spectrum of the infection including the correlation between

infection, disease and the detection of antibodies
 evidence of human-to-human transmission to identify, for example, evidence

of household and occupational risk of transmission and acquisition.
Seroprevalence studies could be used to determine the level of immunity in the

population and may provide a useful indicator of the risk of a second surge in cases
after social distancing measures are lifted.(97) Studies to estimate the level of
immunity to the virus may be carried out after a consistent decline in the number of
cases identified has been observed in order to inform the safe and timely lifting of
social distancing restrictions. Such studies can also facilitate evaluation of the
effectiveness of any measures introduced to prevent viral transmission (for example,
social distancing, school closures) and the requirement to continue such measures.
The use of population-level seroprevalence studies to inform a public health

response is well documented in the context of other respiratory pathogens including
the Middle East respiratory syndrome (MERS) coronavirus and the 2009 influenza
pandemic.(105, 106)
Population level seroepidemiological studies are resource intensive. Interpretation of

the findings is critically dependent on a wide range of factors including the
demographics of the population tested, the specificity of the test used and issues
relating to the sample type and handling. Any decision to implement population-level
testing should therefore only be undertaken in the context of a well-designed
research study with appropriate governance and controls.
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5. Diagnostic tests approved for use internationally
Key points
 An increasing number of diagnostic tests have been approved or authorised

for use internationally to address the growing spread of COVID-19.
 To facilitate increased access to diagnostic tests, many international

regulatory authorities have established accelerated regulatory pathways in
relation to the development of in-vitro diagnostics.
 The Food and Drug Administration (FDA) issued ‘immediately in effect

guidance’ that permits the development and distribution by commercial
manufacturers, or development and use by laboratories, of serology tests to
identify antibodies to SARS-CoV-2, provided the test has been validated and
notification has been provided to the FDA.
 The Health Products Regulatory Authority (HPRA) in Ireland has developed a

regulatory derogation process for the urgent assessment of applications to
use critical non-CE marked medical devices to address the COVID-19
emergency nationally.
 To date, the tests that have been approved or authorised for use
internationally largely include molecular tests and immunoassays.
5.1 Introduction
An increasing number of diagnostic tests have been approved or authorised for use
internationally to address the growing spread of COVID-19. The scale of the
pandemic has resulted in regulatory authorities in many countries establishing
accelerated regulatory pathways in relation to the development of in-vitro
diagnostics to facilitate access to critical tests. This section presents a brief overview
of the regulatory processes that have been introduced for the development and use
of diagnostic tests in a number of different countries, including the US, South Korea,
Singapore, Australia, Canada, and Ireland, and provides a list of the tests that have
been approved or authorised for use in these settings.
5.2 An overview of the international regulatory processes
On 4 February 2020, the FDA in the US moved from approving diagnostic tests to
authorising their use through emergency use authorizations (EUAs).(107) On 29
February 2020, it subsequently issued an ‘immediately in effect guidance’ that
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permitted the development and distribution by commercial manufacturers, or

development and use by laboratories, of serology tests to identify antibodies to
SARS-CoV-2, provided the test had been validated and notification was provided to
the FDA of its commercial use.(107)
In South Korea, a number of diagnostic tests have been made available for
commercial use through the same EUA as in the US(108) since 4 February 2020.(109)
In Singapore, on 29 January 2020, the Health Sciences Authority (HAS) granted
provisional authorisation for a number of diagnostic tests to be used commercially to
ensure the timely availability of good quality tests.(110) In Australia, the Therapeutic
Goods Administration (TGA) is undertaking an expedited assessment of all medical
devices associated with the detection of COVID-19 and has already approved a
number of tests for use under the Australian Register of Therapeutic Goods
(ARTG).(111) The Minister for Health in Canada approved an interim order on 18
March 2020 to expedite the review of medical devices, including test kits, for the
detection of COVID-19.(112) Priority is being given to diagnostic tests that use nucleic
acid technology (molecular tests) in Canada.
In Europe, diagnostic tests are considered in vitro diagnostic devices which must be
CE-marked in accordance with the In Vitro Diagnostic Medical Devices Directive (IVDD;
98/79/EC) before being placed on the market. Laboratory-based tests for COVID-19
and near-patient tests (professional use tests) are classified as general category IVDs.
Under this directive, manufacturers are required to specify device performance
characteristics and for general category IVDs self-declare conformity with the safety
and performance characteristics listed in the Directive. Devices intended for self-
testing, that is, for use directly by patients, must be assessed by a Notified Body for
the self-testing aspects.
A number of test for COVID-19 are now CE-marked. In Ireland, the HPRA is the
Competent Authority for medical devices and IVDs, and monitors the safety of
medical devices and IVDs after they are placed on the market. The HPRA has also
developed a national regulatory derogation process for the urgent assessment of
applications to facilitate the use of critical non-CE marked medical devices and IVDs
in the context of the COVID-19 emergency in Ireland.(113)
5.3 Tests approved or authorised for use internationally
Lists of the diagnostic tests reported to have been approved or authorised for use in
different regions is provided in Appendix A. To date, these largely comprise
molecular tests and immunoassays. The molecular tests are aimed at pathogen
detection and are typically PCR-based tests intended for use in laboratory settings by
skilled technologists, although some are designed as near-patient testing devices
that can be used in non-laboratory settings and require minimal training. Several
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antigen tests for which CE-marking is claimed are also listed in Appendix A, Table
A.2. Antigen tests are aimed at pathogen detection and are therefore intended to
identify active infection. The immunoassays predominantly comprise rapid antibody
tests. These detect the body’s immune response to an infection and are helpful in
determining a history of infection rather than active infection.
A list of tests approved or authorised for use in Australia, Canada, Singapore, South
Korea, and the US detailed in Appendix A, Table A.1. This list was compiled through
a review of the relevant government websites for the five jurisdictions.(108-112) There is
no centralised list of verified CE-marked tests. A list of tests for which CE-marking is
claimed was compiled from a review of a number of grey literature sources,
specifically a report by the Saw Swee Hock School of Public Health (Singapore) and
the online repositories FIND, 360Dx, and Rapid microbiology (Appendix A, Table
A.2).(114-117) Although some of the diagnostic tests may conform to the relevant EU
legislation for CE markings, they may not be available to purchase in Europe as they
may be intended for third-country markets, for example.(36)
5.4 Discussion
Many international regulatory authorities have established accelerated regulatory

pathways in relation to the development and use of diagnostic tests to facilitate
increased access to diagnostic tests during the COVID-19 pandemic. The majority of
the tests that have been approved or authorised for use largely include molecular
tests and immunoassay tests, which predominantly comprise rapid antibody tests. As
yet, none of the rapid antibody tests have been independently validated meaning
the clinical performance of these tests remains uncertain. The next section presents
an overview of the performance characteristics of alternative diagnostic testing
approaches, in particular rapid diagnostic testing approaches.
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6. Performance characteristics
Key points
 This section comprises a review of the characteristics of a selection of IVD
tests for COVID-19 claiming CE-marking. Due to time constraints, the claimed
CE-marking was not verified with relevant authorities. Its purpose is to
illustrate the number and range of IVDs commercialised for COVID-19.
 Prior to their introduction as standalone diagnostic tests, it is considered best

practice to perform clinical validation of the performance of test kits compared
with an existing validated protocol for the gold-standard test. The evidence
presented in this section is primarily from manufacturer sites and therefore
independent validation of the data reported is still required.
 Preliminary evidence of independent validation of diagnostic assays for

detection of SARS-CoV-2 is beginning to emerge in the published literature,
but none of these studies have yet been peer-reviewed. In addition to
independent validation, local verification of test performance should be
undertaken in the setting in which use of the test is intended. All diagnostic
testing should be undertaken in the context of an ongoing quality assurance
programme to ensure confidence in the test results for both the physician and
the patient.
 Of the included laboratory-based RT-PCR tests, all used nucleic acid

amplification technology (NAAT). Performance data were not consistently
reported with manufacturer-reported clinical sensitivity and specificity
identified for less than one third of devices. Values ranged from 96%-100%
and 94%-100%, respectively.
 Of the included tests for detection of antibodies to SARS-CoV-2 (including

laboratory-based and rapid assays) all used immunoassay technology.
Performance data were not consistently reported. Manufacturer-reported
clinical sensitivity and specificity were identified for approximately 60% of
devices, with values ranging from 85-100% and 91-100%, respectively. Of
note however, the reference standard used for comparison of diagnostic
performance was reported by less than half of the manufacturers. Analytical
sensitivity (limit of detection) and specificity (cross-reactivity) were
infrequently reported.
 Other tests (an antigen rapid assay and microfluidic chip) for diagnosis of
COVID-19 were included, but sensitivity and specificity were not reported by
the manufacturers.
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 Prior to their introduction as standalone diagnostic tests, it is considered best

practice to perform clinical validation of the diagnostic performance of test
kits compared with an existing validated protocol for the gold-standard test.
 Manufacturer innovation has led to the development of near-patient tests for

SARS-CoV-2 antibody detection. However, the implementation of these tests
in non-laboratory healthcare settings would need to be accompanied by a
quality assurance programme to mitigate against any potential health and
safety risks, in accordance with criteria set out by the HSE’s National Clinical
Programme for Pathology.
6.1 Introduction
This section provides an overview of the performance characteristics of alternative
diagnostic testing approaches. These include:
 sensitivity and specificity

 test turnaround time
 organisational and infrastructural requirements.
6.2 Methods
Diagnostic test accuracy

Diagnostic test accuracy (DTA) of tests designed to detect SARS-CoV-2 reflects how
well the test discriminates between those who do, and do not have COVID-19. To
determine the DTA of an index test, its performance must be compared with that of
a ‘gold standard’ diagnostic test (that is, the best available method for determining
the presence of disease) in terms of sensitivity and specificity.
Sensitivity is the ability of an index test to accurately identify those who have the
condition: the proportion of people with the condition who receive a positive test
result. The specificity of a screening test is its ability to correctly identify those who
do not have the condition: the proportion of people without the condition who
receive a negative test result. In order to calculate sensitivity and specificity,
individuals are classified according to whether the screening test is positive or
negative, and whether the ‘gold standard’ is positive (disease present) or negative
(disease absent) – see Table 6.1.
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Table 6.1. Relationship between a screening test result and the occurrence
of the condition
Test result Condition present* Condition absent*
Positive True positive (a) False positive (b)
Negative False negative (c) True negative (d)
* As determined by the gold standard diagnostic test

Sensitivity is calculated as a/(a+c). Specificity is calculated as d/(b+d).
Information sources
There is no centralised list of verified tests that have a Conformité Européenne (CE)
marking. For illustrative purposes only, a convenience sample was compiled from
devices for which CE-marking was claimed by the manufacturer. Data on the
characteristics and performance of the devices were obtained from manufacturer
websites and technical documentation. Where an accompanying manuscript
submitted for publication was identified, these data were included. Given the time
constraints for this review, it was not possibly to contact all relevant authorities to
confirm registration of the tests by the manufacturer or their authorised
representative, so it is possible that the list includes IVDs that do not meet the
requirements for CE-marking.
A systematic search was conducted up to 27 March 2020 in accordance with the

HIQA protocol for evidence synthesis to support SARS-CoV-2 public health response
in Ireland to supplement the manufacturer-specific data.
While a systematic review of the literature is routinely used in HTA to assess

diagnostic test accuracy, this approach was not adopted in this rapid assessment as
such a review was considered premature at the time this assessment was
undertaken. SARS-CoV-2 is a novel pathogen in humans first detected in December
2019. A full systematic review would require the definition of clear review questions
(for example, using the population, intervention, comparator, outcomes, study
design (PICOS) framework) and quality appraisal. Literature published in the first
four months of the year (January to April 2020) are primarily in the form of case
reports and case series. The majority of the publications have not as yet been peer-
reviewed. The findings of the studies should therefore be interpreted with caution
and will require confirmation using larger more robust study designs. As evidence of
a non-peer-reviewed variety is rapidly emerging, the data presented in this section
focuses on that identified from grey literature sources and that reported by
manufacturers as an illustration of the number and range of devices being brought
to the market.
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Data quality
The tests included in this section are considered as in-vitro diagnostic medical
devices and are identified by the respective manufacturers as CE-marked in
accordance with the IVD Directive (98/79/EC) under which they are classified as
general category IVDs. Under this directive, manufacturers are required to specify
device performance characteristics and self-declare conformity with the safety and
performance characteristics listed in the Directive. It is noted that the performance
of both laboratory-based tests and near-patient testing devices may differ to that
reported by manufacturers for the purposes of CE-marking. Prior to their
introduction as standalone diagnostic tests, clinical validation of the diagnostic
performance compared with a gold-standard would be considered best practice.
The performance data collated in this section of the report may be subject to bias as
they are limited to the manufacturer-reported characteristics. Prior to their
introduction as standalone diagnostic tests, test kits require independent validation
and verification for use at a local level. Clinical validation of the diagnostic
performance of the test kit should be compared with an existing validated protocol
for the gold-standard, but may be conducted on the basis of a truncated validation
run involving fewer samples, with risk mitigated by enhanced surveillance of test
performance, given the current requirement for rapid deployment.
None of the included manuscripts was peer-reviewed (as of 2 April 2020) and quality
appraisal was beyond the scope of the current rapid HTA. In general, clinical data
were presented either in a summary table (as per Table 4.1) without adequate
description of methods undertaken in the clinical study or as standalone point
estimates of DTA without any description at all. All of the extracted data were
checked by a second reviewer.
Data analysis
Where manufacturers reported sufficient data to compile two-by-two tables (to
determine the number of true positives, false negatives, true negatives and false
positives), mean values and imprecision (that is, 95% confidence intervals) were
estimated for sensitivity and specificity using the metaprop command in the meta
package of RStudio version 3.6.3. Subgroup analysis, where appropriate, was
performed on these data only (that is, devices were excluded from subgroup
analysis where insufficient data were reported) and presented in forest plots. A
summary pooled estimate of DTA was not undertaken.
6.3 Findings
The findings are presented according to the following headings:
 RT-PCR tests
 Antibody tests
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 Other tests (antigen and microfluidic chip).
As described in Section 4, these test types have clinical utility during different
periods within the clinical pathway. Therefore, they should not be viewed as
competing alternatives.
RT-PCR
The initial identification of SARS-CoV-2 was based on non-commercial laboratory

protocols which were published on the WHO website. The initial testing protocols,
include multiple steps involving manual manipulation and take six to seven hours to
complete. However, RT-PCR is not a new technology; it is widely used in specialised
laboratories testing for viral testing. Therefore companies have developed and
commercialised RT-PCR test kits, many of which work off existing platforms already
deployed in Irish hospital and testing laboratories.
As noted, prior to their introduction as standalone diagnostic tests, best practice is

for independent clinical validation of the diagnostic performance of the test kit
compared with an existing validated protocol for the gold-standard as well as local
level verification in the setting in which the test will be used. Given the current
requirement for rapid deployment, this may be on the basis of a truncated validation
run involving fewer samples, with risk mitigated by enhanced surveillance of test
performance.
Some of the test kits can be used in platforms with a higher degree of automation,
requiring less manual manipulation, less reagent and that are amenable to batch
testing, thereby facilitating shorter turnaround times and a higher throughput of
tests. Advantages of test kits suitable for use on existing platforms include that the
platforms are already deployed in a number of the hospital laboratories, and there is
a level of multidisciplinary experience and confidence in their use
As described in Section 4, the performance of RT-PCR is instrument-dependent, and

influenced by the reaction components and conditions. Rapid PCR test kits with
optimised target regions and primer sequences increase the speed and convenience
of PCR to support timely and accurate diagnosis, but upscaling of testing with the
use of rapid PCR kits must leverage from existing laboratory resources to optimise
the expansion of testing. Optimised throughput and diagnostic performance of the
PCR test kits presented in this section rely on the availability of reagents, primer
sequences and automated systems.
A convenience sample of 17 laboratory-based RT-PCR tests was identified for

inclusion, all of which use nucleic-acid amplification technology (NAAT).(118-134)
Overall, 12 manufacturers reported the technology’s sample type on their website.
These mainly comprised samples of the lower and upper respiratory tract such as
bronchoalveolar lavage fluid, nasopharyngeal and oropharyngeal swabs, and
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sputum. Test capacity, run time and additional laboratory materials (beyond that of
the test kit) required were reported by six, 11 and six of the manufacturers,
respectively. Throughput was reported by two manufacturers according to their
manufacturer-specific automated systems.(128, 132) Primerdesign Ltd reported that
their Cobas® SARS-CoV-2 (Real-Time PCR assay) could deliver 384 and 1,056 results
in eight hours using the Cobas® 6800 System and Cobas® 8800 System,
respectively.
Device performance was reported both analytically and clinically. Clinical sensitivity
and specificity was reported by five of the device manufacturers.(121, 123, 124, 128, 132) Of
these, four manufacturers reported the underlying clinical data.(120, 121, 128, 132) One
manufacturer reported clinical diagnostic data for lower and upper respiratory tract
samples (compared with the CDC’s FDA-EUA 2019-Novel Coronavirus (2019-nCoV)
Real-time RT-PCR Panel).(132) The comparator was not reported by the other
manufacturers. Across all of these data (n=5), clinical sensitivity ranged from 89%
to 100%, and clinical specificity ranged from 94% to 100%. For some tests,(121, 128)
measures of diagnostic test accuracy were based on non-clinical performance
evaluation whereby samples from healthy individuals were spiked with viral targets
prior to RNA extraction and subsequent performance evaluation.
Analytical sensitivity (limit of detection) was reported by nine manufacturers

(Appendix B, Table B1). Six manufacturers reported that there was no cross-
reactivity with other viral infections, such as influenza (but the assessment of cross-
reactivity varied by manufacturer).(120, 121, 127, 131, 132, 134) The others did not comment
on the potential for cross-reactivity. Estimates of cross-reactivity are dependent on
the pathogens included in the assessment. Not all manufacturers investigated cross-
reactivity with other coronaviruses known to demonstrate a high degree of sequence
similarity. Manufacturer-specific data are presented in (Appendix B, Tables B1 and
B2).
Given that these data have been self-reported by the manufacturers, they should be
interpreted with caution, and require validation and verification prior to
establishment of standardised local use. A study evaluating the performance of four
manufacturer-claimed CE-marked NAATs widely used in China during the pandemic
found that the analytical sensitivity of the four assays was significantly lower than
that claimed by the NAAT manufacturers.(135) The clinical sensitivity of one of the
assays was also significantly reduced compared with that reported by the
manufacturer. Clinical sensitivity may also vary according to primer-probe sets used
during RNA extraction.(136)
Antibody tests
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As described in Section 4, it has been suggested that antibody tests may present
operational utility in particular circumstances later in the disease course (following
seroconversion), such as in decision-making regarding return to work for healthcare
workers. There has been considerable focus in manufacturer innovation on the
development of near-patient testing devices for SARS-CoV-2 antibody detection. As
testing is currently laboratory-based, the implementation of near-patient testing in
other healthcare settings would need to be accompanied by a quality assurance
programme to mitigate against any potential health and safety risks, in accordance
with criteria set out by the HSE’s National Clinical Programme for Pathology.
Therefore, the findings reported below should be interpreted in the context of an
accompanying quality assurance programme.
A convenience sample of 13 antibody (including laboratory-based and rapid assays)

tests for detection of the SARS-CoV-2 antibody were identified for inclusion, all of
which use immunoassay technology.(137-149) All of the manufacturers reported the
technology’s sample type on their website comprising whole blood, serum and
plasma. Sample capacity was reported by eight manufacturers (one unit in each
case). Runtime was reported by 11 manufacturers ranging from 2-30 minutes.
Additional testing materials (beyond that of the test kit) required was reported by
three manufacturers – one manufacturer stated that no additional materials or
equipment were required.(147)
The comparator for estimation of clinical sensitivity and specificity was reported by
three manufacturers, being one of or a combination of RT-PCR, clinical diagnosis or
single IgG/IgM detection (for comparison with dual detection).(138, 140, 146) Clinical
sensitivity and specificity was reported by eight manufacturers.(137, 138, 140, 141, 144-146,
149) Of these, five manufacturers reported the underlying clinical data.(137, 138, 140, 146,
149) Across all of these data (n=8), clinical sensitivity ranged from 85% to 100%, and
clinical specificity ranged from 96% to 100%. However, these ranges should be
interpreted with caution given that the reference standard used for comparison was
not reported by 10 of the manufacturers. The data from one manufacturer has been
included as part of a manuscript submitted for peer-review publication.(140, 150) A
manuscript reporting the evaluation of nine commercial antibody tests undertaken
by the Danish national state laboratory was also identified. The performance data for
three immunoassays evaluated in the study were included in this section.(141-143, 151)
Sufficient data were provided by four manufacturers to enable subgroup analysis

according to single IgG or single IgM detection.(137, 138, 146, 149) In antibody tests for
single IgG detection, clinical sensitivity ranged from 97% to 100% and clinical
specificity ranged from 98% to 100%. In antibody tests for single IgM detection,
clinical sensitivity ranged from 88% to 94% and clinical specificity ranged from 96%
to 100%.
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Analytical sensitivity (limit of detection) was reported by only one manufacturer at

3.4 ng/mL and 210 ng/mL for IgG and IgM, respectively.(146) Only one manufacturer
reported no cross-reactivity with human influenza A and B viruses, anti-respiratory
syncytial virus, anti-adenovirus, hepatitis B virus antigen, anti-Treponema pallidum,
anti-helicobactor pylori, anti-human immunodeficiency virus, and anti-hepatitis C
virus.(149) The others did not comment on the potential for cross-reactivity.
Manufacturer-specific data are presented in (Appendix B, Tables B3 and B4) and in
forest plots in Appendix B (Figures B1-B3).
Other tests (antigen and microfluidic chips)
Two other manufacturer-claimed CE-marked tests for diagnosis of COVID-19 were

identified – an antigen rapid assay and a microfluidic chip.(152, 153) Turnaround for
these tests was 10 minutes for the antigen test and 40 minutes for the microfluidic
chip. Sensitivity and specificity were not reported by the manufacturers. Further
details of these tests are presented in Appendix B, Table B5.
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Rapid HTA of Alternative Diagnostic Technologies for the Detection of SARS-CoV-2
7. Discussion
The assessment was undertaken as a rapid assessment within very restricted
timelines and in the context of a global pandemic of a new pathogen in humans. It
therefore differs from a standard health technology assessment in its scope and the
approaches adopted to synthesising the available evidence.
In particular, while a systematic review of the literature is routinely used in HTA to

assess diagnostic test accuracy, this approach was not adopted in this rapid
assessment as such a review was considered premature. SARS-CoV-2 is a novel
pathogen in humans first detected in December 2019. Literature published in the
first four months of this year are primarily in the form of case reports and case
series; the majority of the publications have not as yet undergone peer-review. The
findings of the studies should therefore be interpreted with caution and will require
confirmation using larger more robust study designs.
This preliminary review is therefore limited to manufacturer-reported evidence for

the performance characteristics of tests they claim are CE-marked. It therefore may
be subject to bias. As noted in Section 6, prior to their introduction as standalone
diagnostic tests, test kits require independent validation and verification for use at a
local level.
Pre-analytical vulnerabilities, independent clinical validation and quality

assurance
While there has been substantial discussion of the steps necessary to ensure to
validate the test accuracy of the individual tests deployed, it must also be
highlighted that the pre-analytical phase can be a major source of errors in
diagnostic testing. To mitigate such risks, training and quality assurance procedures
are required to ensure that test samples are appropriately identified and reported
(that is, right result, right patient), and to ensure adequate procedures for correct
specimen (for example, swab) collection, handling, transport, and storage.
The results of formal clinical validation studies for commercialised, CE-marked, rapid
diagnostic tests funded by the European Commission and EU member states and by
WHO referral laboratories are awaited. Until the clinical performance of these tests,
in particular rapid diagnostic tests based on antigen detection and host antibody
detection, has been validated, the WHO has strongly advised against their use in any
setting other than a research setting. Making the distinction between the analytical
performance and the clinical performance of diagnostic tests, performance criteria
for RT-PCR, antigen-based and antibody-based tests have been published in a
working document of the European Commission to provide additional guidance to
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the legally obligatory requirements defined in the IVDR to inform research in this
area.(68) These criteria are based on the principles of good analytical (testing)
practice. The working document notes the current absence of control samples and
reference materials as a particular challenge to establishing the diagnostic test
accuracy of antigen and antibody tests.(68) The WHO and ECDC have noted that they
will update their guidance on the use of diagnostic testing approaches used in
laboratories or as near-patient tests in line with the findings from these validation
studies. However, the requirement for additional validation studies to confirm that
this test performance can be replicated in the context in which they are being used
must be emphasised. Given the current requirements for rapid deployment of CE-
marked devices, this validation may be conducted on the basis of a truncated
validation run involving fewer samples, with risk mitigated by enhanced surveillance
of test performance.
While adequate test accuracy and precision may be achieved under idealised
circumstances in the laboratory, these may be negatively impacted when used as
near-patient tests. Appropriate staff training and use of robust standardised
operating procedures may be required to moderate these sources of error. In
accordance with existing Irish guidelines for the safe and effective management and
use of near-patient (point-of-care) testing, such testing should be performed in the
context of an ongoing quality assurance programme to ensure adequate
performance of the tests in the context in which they are being used and provide
confidence in the test results for both the diagnosing physician and the patient.
Consideration should also be given to a requirement that all testing should be ISO-
accreditable, including meeting requirements in relation to internal quality control,
quality assurance and the recording of training and test results.
Operational utility and potential deployment of different diagnostic testing

approaches
The potential operational utility of different molecular and immunological testing

approaches was described in detail in Section 4. A clear distinction was drawn
between tests that can be used to diagnose acute infection and those that indicate
past exposure to the virus.
RT-PCR remains the most sensitive and specific validated method for detection of
cases. However, as noted in Section 2.6, negative test results do not preclude SARS-
COV-2 infection and cannot be used as the sole basis for patient management
decisions. Discrepancies between the analytical performance and the clinical
performance of an assay may arise due to pre-analytical issues as highlighted above
and due to the impact of differences in viral dynamics over the course of an
infection. Specifically, false negative test results may occur if samples are tested
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during the early incubation period or during the late convalescent phase, when virus
levels may be undetectable. Differences in viral dynamics over the course of an
infection may also contribute to discordance between test results based on different
specimens (upper versus lower respiratory tract). High test sensitivity is clinically and
epidemiologically relevant because asymptomatic and mild cases of COVID-19 have
been increasingly recognised. While clinical severity is not always correlated with
viral load, asymptomatic and mild cases may have viral loads below the limit of
detection of certain tests. The true prevalence of SARS-CoV-2 infection might be
underestimated by less sensitive assays. Patients with false negative results may
serve as a potential source for propagating the pandemic.
The use of rapid antigen tests to facilitate early diagnosis of acute infection with
SARS-CoV-2 to facilitate patient triage and cohorting and or to alleviate pressure on
laboratory testing is consistent with approaches adopted in international clinical
guidelines for the diagnosis of seasonal influenza. Such guidelines note that where
there is access to RT-PCR assays, these are considered the preferred test on the
basis of diagnostic test accuracy with the recommendation that antigen detection
tests should only be used to rule-in suspected cases. All negative test results should
be confirmed by RT-PCR or molecular methods with comparable accuracy.
The role of antibody testing to identify those previously exposed to SARS-CoV-2 was
discussed in detail in Section 4. As noted, its operational utility of antibody testing
can be considered in the context of three potential scenarios: patient level testing
(to inform clinical management); cohort testing to inform staff deployment (for
example, immunity passports); and population-level seroepidemiological studies to
inform public health strategies.
The use of patient-level testing and population-level seroepidemiological testing are

well documented in healthcare. However, the use of antibody testing to inform staff
deployment is an unprecedented, but potentially necessary step given the extreme
pressures on the healthcare system and the economic ramifications of the current
COVID-19 global pandemic. Notwithstanding this, deployment of antibody testing in
this context has extremely important implications for both the administration and
reporting of tests as well as well as the overall governance of any testing strategy.
This is particularly the case given the uncertainty around the potential for re-
infection with the same or a different antigenic strain of the SARS-CoV-2 virus. As
highlighted in Section 4, prior to deployment, consideration should be given to who
will be responsible for:
 providing the antibody test and in what setting will it be provided
 decision-making in relation to the staff redeployment
Page 65 of 121
 follow up of the individual to ensure community immunity in the context of an

ongoing pandemic or evidence of the emergence of new strains of the virus.
Furthermore, it is noted that how, where, and by whom any testing to inform staff
redeployment is implemented could also have important implications for how the
veracity of an individual’s test result is ensured given the financial imperative for
many individuals to return to work.
Implications of the IVD Regulation (IVDR 2017/746/EU) for IVDs
including near-patient testing devices
All IVDs including those for near-patient testing are subject to EU Regulation
2017/746 on In Vitro Diagnostic Devices (the IVDR) which came into force at the
end of May 2017. The Regulation has a staggered transitional period, with full
application after five years (May 2022). The regulation will replace the existing IVD
directive (98/79/EC) and is intended to strengthen the current regulatory system by
providing:
 clearer requirements regarding clinical data for IVDs, and their assessment;
 more specific product requirements, such as unique identifiers for IVDs;
 improved pre-market assessment and post-market surveillance of all high-risk

devices;
 increased control and monitoring of Notified Bodies by the National

Competent Authorities and the Commission;
 more stringent requirements for near-patient tests;
 enhanced traceability for IVDs.
One of the key changes under the IVDR relates to the conformity assessment
procedures required of manufacturers prior to an IVD being placed on the market.
Requirements vary based on the risk classification of the device, that is, for low risk
(Class A) up to high risk (Class D). Assessment and certification by a notified body
will be required for those IVDs in Classes B, C, and D. Class A devices placed on the
market in a sterile condition shall also require notified body involvement, limited to
the sterile aspects of the product. Devices for near-patient testing are classified in
their own right under Rule 4(b) of Annex VIII of the IVDR.
Depending on the intended purpose specified by the manufacturer, SARS-CoV-2

near-patient test devices will likely be in Class D. This represents a significant
change to the existing regulatory system, where the majority of IVDs are self-
declared by the manufacturer rather than being assessed by a notified body.
Page 66 of 121
Detailed requirements for the performance evaluation of IVDs are outlined in the
IVDR. The performance evaluation will comprise data on the scientific validity,
analytical performance and clinical performance of the device. Under the IVDR, IVDs
for near-patient testing must perform appropriately for their intended purpose taking
into account the skills of the intended user and the potential variation in the user’s
technique and environment, with sufficient information provided in order for the user
to be able to correctly interpret the result provided. It is recognised that the
enhanced regulatory burden arising from implementation of the IVDR may impact
the number and range of IVDs on the market.
The Health Products Regulatory Authority (HPRA) is designated as the Competent

Authority for medical devices and IVDs in Ireland. Its role is to ensure that all
medical devices sold into the Irish market comply with the relevant legislation. This
means that a medical device must achieve the performance criteria specified by the
manufacturer and in doing so must not compromise the health and safety of
patients, service providers and any other persons. In its role as the competent
authority, the HPRA operates a vigilance system for medical devices. Vigilance issues
include adverse incidents and field safety corrective actions (FSCAs).
Page 67 of 121
8. Conclusions
This assessment was undertaken as a rapid HTA within very restricted timelines and
synthesising the available evidence. Evidence to support the analytical performance
of diagnostic tests for SARS-CoV-2 will continue to emerge. Evidence will also
emerge to support the clinical effectiveness and safety of different testing strategies
to inform patient care and the public health response to COVID-19. Revisions to any
national testing strategy may be required as the evidence evolves. In time, a full
HTA that takes consideration of the cost-effectiveness, resource considerations and
budget impact of alternative testing strategies may be required to ensure the best
outcomes for the resources available.
Bearing in mind the caveats of the approach adopted, and arising from the findings
of this report, the following conclusions can be drawn:
 Diagnostic tests for SARS-CoV-2 can be broadly grouped into two categories:
those aimed at detecting the virus and those that detect the body’s immune
response to the infection (past exposure to the virus). These should not be
considered competing alternatives; both testing approaches are clinically
relevant at different time points during the clinical course of infection.
 The ability of any diagnostic test to achieve an acceptable clinical

performance is contingent on it being performed within the appropriate
timeframe for the condition in question (right test, right time, right person),
with due consideration of the principles of good pre-analytical and analytical
testing practice.
 Real-time PCR is the preferred method to detect SARS-CoV-2 RNA and to

confirm acute infection early in the clinical course of COVID-19 disease. To
increase diagnostic testing capacity, efforts are underway to develop
enhanced molecular methods with reduced turnaround times and
instrumentation requirements and higher throughput.
 Antigen detection tests could be used to supplement current laboratory-based

real-time RT-PCR case detection. However, analytical and clinical validation of
these tests is needed to inform their safe and effective use in clinical decision-
making.
 Contingent on the availability of accurate, validated tests, antibody tests could

be used later in the clinical course of infection or following recovery to identify
those who have been exposed to SARS-CoV-2. While the use of antibody tests
Page 68 of 121
to provide ‘immunity passports’ has been proposed in the literature, little is

known about the adequacy of the immune response or the duration of
immunity, and so it is not known if reinfection can occur. The primary role of
antibody tests is likely to be as part of well-constructed seroprevalence
studies to model the course of the pandemic and inform the public health
response.
 Work is currently underway to validate the analytical performance of the

different diagnostic tests. Prior to their introduction as standalone tests,
clinical validation studies are also required to confirm that test performance
can be replicated in the context in which the test is being used. All testing
should be undertaken in the context of an ongoing quality assurance
programme to provide confidence in the test results for both the physician
and the patient.
 A cohesive national strategy is needed to ensure the right tests are

undertaken in the right people at the right time for the right purpose. This is
necessary to ensure appropriate governance of SARS-CoV-2 testing and
should include clear criteria for the administration and reporting of tests.
Planning now to support delivery of the strategy will facilitate rapid
deployment of tests that meet the requisite standards once available and
validated for use.
Page 69 of 121
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114. 360Dx. [Available from: https://www.360dx.com/.
115. FIND. [Available from: https://www.finddx.org/.
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Page 76 of 121
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%20Coronavirus%20(2019-
nCoV)%20Detection%20Kit&bas=Bosphore%20Novel%20Coronavirus%20(2019-
nCoV)%20Detection%20Kit.
119. BGI Europe. Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV(SARS-CoV-2)
[Available from: https://www.bgi.com/global/molecular-genetics/2019-ncov-
detection-kit/.
120. CerTest Biotech. VIASURE SARS-CoV-2 Real Time PCR Detection Kit [Available from:
https://www.certest.es/viasure/.
121. Co-Diagnostics. Logix Smart COVID-19 Test (RT-PCR) [Available from:
http://codiagnostics.com/products/diagnostic-solutions/logix-smart-covid19/.
122. Credo Diagnostics. VitaPCR COVID-19 assay [Available from:
https://www.credodxbiomed.com/en/news/100-credo-diagnostics-biomedical-
vitapcr-sars-cov-2-assay-garners-ce-mark.
123. Genomica. qCOVID-19 Real time Multiplex RT-PCR [Available from:
http://genomica.com/covid-19/?lang=en.
124. Genomica. CLART®COVID-19 Real time Multiplex RT-PCR [Available from:
http://genomica.com/covid-19/?lang=en.
125. Kogene Biotech. PowerChek™ 2019-nCoV Real-time PCR Kit [Available from:
http://www.kogene.co.kr/eng/about_us/news/listbody.php?h_gcode=board&h_code=7
&po_no=288.
126. Liferiver Bio-Tech. Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit
[Available from: https://www.mobitec.com/products/in-vitro-diagnostics/real-time-
pcr-diagnostic-kits/10200/novel-coronavirus-2019-ncov-real-time-multiplex-rt-pcr-
kit-detection-of-3-genes.
127. OSANGHealthcare. GeneFinderTM COVID-19 Plus RealAmp Kit [Available from:
https://www.elitechgroup.com/documents?search=GeneFinder%20COVID-
19%20Plus%20RealAmp%20Kit.
128. Primerdesign Ltd. Coronavirus (COVID-19) genesig® Real-Time PCR assay [Available
from:
https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_2.pdf?timest
amp=1583401267.
129. Roche Molecular Diagnostics. Cobas® SARS-CoV-2 (Real-Time PCR assay) [Available
from:
https://diagnostics.roche.com/global/en/search.html?q=cobas%C2%AE%20SARS-CoV-
2&autoSuggest=true.
130. Sansure. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit [Available from:
http://eng.sansure.com.cn/index.php?g=portal&m=article&a=index&id=81.
131. SD Biosensor. STANDARD M n-CoV Real-Time Detection Kit for emergency COVID-19
test [Available from: http://sdbiosensor.com/xe/product/7653.
132. Seegene. Allplex™ 2019-nCoV Assay [Available from:
http://www.seegene.com/covid19_detection.
133. Solgent. DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit [Available from:
http://www.solgent.com/english/sub03020102/view/id/45.
134. Vircell. SARS-CoV-2 RealTime PCR kit [Available from:
https://en.vircell.com/products/sars-cov-2-realtime-pcr-kit/.
135. Xiong Y, Li Z-Z, Zhuang Q-Z, Chao Y, Li F, Ge Y-Y, et al. Comparative performance of four
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137. Assay Genie. COVID-19 Rapid POC (Point-of-Care) kit [Available from:
https://www.assaygenie.com/covid-19-rapid-poc-test/.
Page 77 of 121
138. Aytu BioScience. COVID-19 IgG/IgM Rapid Test [Available from:

https://www.accesswire.com/579898/Aytu-BioScience-Secures-Exclusive-US-
Distribution-Agreement-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test.
139. Bioeasy. 2019-NOVEL CORONAVIRUS (2019-nCoV) IgG/IgM GICA RAPID TEST KIT
[Available from: http://en.bioeasy.com.tr/2019-novel-coronavirus-2019-ncov-ab-gica-
rapid-test-kit/.
140. Biomedomics. COVID-19 IgM/IgG Rapid Test [Available from:
https://www.biomedomics.com/products/infectious-disease/covid-19-rt/.
141. CTK Biotech. OnSite COVID-19 IgG/IgM Rapid Test [Available from:
https://ctkbiotech.com/covid-19/.
142. Dynamiker Biotechnology Co. Ltd. 2019 nCOV IgG/IgM Rapid Test [Available from:
http://en.dynamiker.com/index/index/pro_info/aid/606.html.
143. EUROIMMUN AG. ELISA assay for detection of Anti SARS-COV-2 [Available from:
https://www.euroimmun.com/products/indications/infektions-serologie/weitere-
parameter/sars-coronavirus.html.
144. InTec Products. Rapid SARS-CoV-2 Antibody Test [Available from:
https://www.prodiag.nl/store/intec-rapid-sars-cov-2-antibody-igm-igg-test-40-pieces-
copy/.
145. InTec Products. Rapid SARS-CoV-2 Antibody (IgM/IgG) Test [Available from:
https://www.prodiag.nl/store/rapid-sars-cov-2-antibody-igm-igg-test-25-pieces/.
146. Nal von Minden GmbH. Nadal COVID-19 IgG/IgM Test (test cassette) [Available from:
https://www.nal-vonminden.com/en/nadalr-covid-19-igg-igm-test-25-test-
cassettes.html.
147. Raybiotech. Coronavirus (COVID-19) IgM/IgG Rapid Test Kit [Available from:
https://www.raybiotech.com/covid-19-igm-igg-rapid-test-kit/.
148. Snibe Diagnostic. Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits [Available from:
http://www.snibe.com/zh_en/en_newsView.aspx?id=576.
149. Surescreen Diagnostics. Covid-19 IgM/IgG Test cassette [Available from:
https://www.surescreen.com/products/covid-19-coronavirus-rapid-test-cassette.
150. Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and Clinical Application of A
Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis. Journal of
Medical Virology. 2020;n/a(n/a).
151. Lassaunière R, Frische A, Harboe ZB, Nielsen ACY, Fomsgaard A, Krogfelt KA, et al.
Evaluation of nine commercial SARS-CoV-2 immunoassays. medRxiv.
2020:2020.04.09.20056325.
152. Bioeasy. 2019-Novel Coronavirus (2019-nCoV) Antigen Rapid test kit [Available from:
http://en.bioeasy.com.tr/2019-novel-coronavirus-2019-ncov-ag-test-kit-fluorescence-
immunochromatographic-assay/.
153. Shenzhen Shineway Technology. POCT-PCR [Available from:
https://www.bioworld.com/articles/432927-hong-kong-researchers-create-fastest-
coronavirus-diagnostic-test-to-date.
Page 78 of 121
Appendix A – List of internationally approved or authorised SARS-CoV-2 tests

Table A.1 Diagnostic tests currently approved or authorised for use internationally*
Manufacturer SARS-CoV-2 test Australia Canada Singapore South Korea US
Molecular tests
1DROP INC 1COPY COVID-19 QPCR KIT Approved

(Health
Canada)
03/03/2020
Abbott Diagnostics ID NOW COVID-19 EUA
Scarborough, Inc. 27/03/2020
Abbott Molecular Abbott RealTime SARS-CoV-2 assay TGA approved Approved Provisional EUA
17/04/2020 (Health authorization 18/03/2020
Canada) 01/04/2020
25/03/2020
Acumen Research Acu-Corona™ 2.0 Provisional
Laboratories authorization
31/03/2020
Acumen Research Acu-Corona 3.0 Provisional
Laboratories Pte Ltd authorization
13/04/2020
AITbiotech Pte Ltd abTES™ COVID-19 qPCR I Kit Provisional
authorization
05/03/2020
altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S. EUA
22/04/2020
Atila BioSystems, Inc. iAMP COVID-19 Detection Kit EUA
10/04/2020
AusDiagnostics Pty Ltd AusDiagnostics respiratory virus panel (including SARS-CoV-2) test TGA approved
(Australia) 19/03/2020
Avellino Lab USA, Inc. AvellinoCoV2 test EUA
25/03/2020
Page 79 of 121
Becton, Dickinson & BD SARS-CoV-2Reagents for BD MAX System TGA approved Approved EUA08/04/2020
Company 17/04/2020 (Health
Canada)
21/04/2020
Becton, Dickinson & BioGX SARS-CoV-2 Reagents for BD MAX System EUA
Company (BD) 02/04/2020
BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV TGA approved EUA
10/04/2020 26/03/2020
BioFire Defense, LLC BioFire COVID-19 Test EUA
23/03/2020
BioSewoom Inc. Real-Q 2019-nCoV Detection Kit EUA
13/03/2020
BioWalker Pte Ltd BioWalker SARS-CoV-2 Assay Provisional
authorisation
20/04/2020
Centers for Disease Control CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) EUA
and Prevention's (CDC) 04/02/2020
CerTest Biotec SL (Spain) VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit TGA approved
21/03/2020
CerTest Biotech (Spain) VIASURE SARS-CoV-2 Real Time PCR Detection Kit TGA approved
21/03/2020
Co-Diagnostics, a US-based Logix Smart COVID-19 Test (RT-PCR) EUA
molecular diagnostics 03/04/2020
company
Credo Diagnostics VitaPCR™ SARS-CoV-2 Assay Provisional
Biomedical Pte Ltd authorization
01/04/2020
CTK Biotech Inc (United Aridia COVID-19 Real-Time PCR Test TGA approved
States Of America) 24/04/2020
DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit EUA
08/04/2020
Diagnostic Hybrids, Inc. LYRA SARS-COV-2 ASSAY Approved
(Health
Canada)
25/03/2020
Page 80 of 121
Diagnostics Development FORTITUDE KIT 2.0 Provisional

Hub (DxD) authorization
07/02/2020
DiaSorin Molecular LLC Simplexa COVID-19 Direct assay Approved EUA
(Health 19/03/2020
Canada)
09/04/2020
DSO National Laboratories Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus Provisional
authorization
10/03/2020
Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit EUA
17/04/2020
Genetic Signatures Ltd EasyScreen™ SARS-CoV-2 Detection Kit TGA approved
(Australia) 13/04/2020
GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test EUA
19/03/2020
GenoSensor, LLC GS™ COVID-19 RT-PCR KIT EUA
26/04/2020
Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit EUA06/04/2020
Hologic, Inc. Panther Fusion SARS-CoV-2 TGA approved Approved EUA

20/03/2020 (Health 16/03/2020
Canada)
25/03/2020
InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit EUA
07/04/2020
Ipsum Diagnostics, LLC COV-19 IDx assay EUA
01/04/2020
JN Medsys Pte Ltd ProTect™ COVID-19 RT-qPCR Kit Provisional
authorization
19/03/2020
Kogene Biotech PowerChek™ 2019-nCoV Real-time PCR Kit TGA approved EUA
16/04/2020 04/03/2020
KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay EUA
16/04/2020
Laboratory Corporation of COVID-19 RT-PCR Test EUA
America (LabCorp) 16/03/2020
Page 81 of 121
Luminex Corporation ARIES SARS-CoV-2 Assay EUA

03/04/2020
Luminex Molecular NxTAG CoV Extended Panel Assay Approved EUA
Diagnostics, Inc. (Health 27/03/2020
Canada)
26/03/2020
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit EUA
(USA) LLC 15/04/2020
Mesa Biotech Inc. Accula SARS-Cov-2 Test EUA
23/03/2020
MiRXES Pte Ltd MiRXES FORTITUDE KIT 2.0 Provisional
authorization
30/03/2020
NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay EUA
30/03/2020
OSANGHealthcare Korea GeneFinderTM COVID-19 Plus RealAmp Kit Approved EUA
(Health 18/04/2020
Canada)
21/04/2020
PerkinElmer Singapore Pte PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay Provisional
Ltd authorisation
20/04/2020
PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit Approved EUA
(Health 24/03/2020
Canada)
06/04/2020
Primerdesign Ltd. COVID-19 genesig Real-Time PCR assay EUA
20/03/2020
QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel EUA
30/03/2020
Quest Diagnostics Infectious Quest SARS-CoV-2 rRT-PCR EUA
Disease, Inc. 17/03/2020
Quidel Corporation Lyra SARS-CoV-2 Assay EUA
17/03/2020
Roche Molecular Systems, Cobas SARS-CoV-2 TGA approved Approved Provisional EUA
Inc. (RMS) 20/03/2020 (Health authorization 12/03/2020
19/03/2020
Page 82 of 121
Canada)
18/03/2020
Sansure Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR- Provisional
Fluorescence Probing authorisation
23/04/2020
ScienCell Research ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) EUA
Laboratories Detection Kit 03/04/2020
SD Biosensor STANDARD M n-CoV Real-Time Detection Kit for emergency COVID- EUA EUA
19 test 27/03/2020 23/04/2020
SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit EUA
27/04/2020
Seegene Inc (Korea) / All Allplex™ 2019-nCoV Assay TGA approved Approved Provisional EUA EUA
Eights (Singapore) 27/03/2020 (Health authorization 12/02/2020 21/04/2020
Canada) 02/04/2020
09/04/2020
Solgent DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit Approved EUA
(Health 27/02/2020
Canada)
05/04/2020
Spartan Bioscience Inc. Spartan Cube CYP2C19 System Approved
(Canada) (Health
Canada)
11/04/2020
SPD Scientific Pte Ltd / Cepheid® Xpert® Xpress SARS-CoV-2 TGA approved Approved Provisional EUA
Cepheid 22/03/2020 (Health authorization 20/03/2020
Canada) 26/03/2020
24/03/2020
Thermo Fisher Scientific, TaqPath COVID-19 Combo Kit TGA approved Approved Provisional EUA
Inc. 24/03/2020 (Health authorization 13/03/2020
Canada) 20/03/2020
18/03/2020
Trax Management Services PhoenixDx 2019-CoV EUA
Inc. 20/04/2020
Ustar Biotechnologies EasyNat Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA TGA approved
(Hangzhou) Co Ltd (China) (Isothermal Amplification-Real Time Fluorescence Assay) 23/04/2020
Page 83 of 121
Vela Operations Singapore ViroKey SARS-CoV-2 RT-PCR Test Provisional

Pte Ltd authorisation
15/04/2020
Wadsworth Center, New New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR EUA
York State Department of Diagnostic Panel 29/02/2020
Public Health's (CDC)
Antibody tests
Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) SARS-CoV-2 IgG (for use FDA notified
on ARCHITECT)
Abbott Laboratories Inc. SARS-CoV-2 IgG assay FDA notified
Alfa Scientific Designs, Inc. Instant-view plus COVID-19 IgG/IgM Antibody Test FDA notified
Alfa Scientific Designs, Inc. Clarity COVID-19 IgG/IgM Antibody Test FDA notified
Anhui Deepblue Medical COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) FDA notified
Technology Co., Ltd.
Artron BioResearch Inc./ Artron COVID-19 IgM/IgG Antibody Test FDA notified
Artron Laboratories Inc.
Assure Tech (Hangzhou) COVID-19 IgG/IgM Rapid Test Device FDA notified
Co., Ltd.
Atlas Link NovaTest: One Step COVID-19 IgG/IgM rapid test FDA notified
(Beijing)Technology Co., Ltd
Autobio Diagnostics Anti-SARS-CoV-2 Rapid Test EUA
24/04/2020
Axium BioResearch, Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test FDA notified
Beijing Beier Bioengineering 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P) FDA notified
Co., Ltd
Beijing Decombio Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette FDA notified
Biotechnology Co., Ltd. (Serum/Plasma/Whole blood)
Beijing Diagreat 2019-nCoV IgG Antibody Determination Kit FDA notified
Biotechnologies Co., Ltd.
Beijing Diagreat 2019-nCoV IgM Antibody Determination Kit FDA notified
Beijing Diagreat 2019-nCoV IgG/IgM Antibody Rapid Test Kit FDA notified
Page 84 of 121
Beijing Kewei Clinical Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit FDA notified
Diagnostic Reagent Inc.
Beijing O&D BIOTECH Co., Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal FDA notified
LTD. Gold)
Beijing Wantai Wantai SARS-CoV-2 Ab Rapid Test kit TGA approved FDA notified
Biologicalpharmacy 27/03/2020
Enterprise Co Ltd (China)
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit FDA notified
Biobase Biodustry SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) FDA notified
(Shandong) Co., Ltd
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test FDA notified
(Cassette Format)
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody FDA notified
Test (Strip Format)
Biohit Healthcare (Hefei) SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) FDA notified
Co., Ltd.
Biolidics Limited Nanjing Vazyme/Biolidics 2019-nCoV IgG/IgM Detection Kit Provisional FDA notified
authorization
20/03/2020
BioMedomics, Inc. COVID-19 IgM-IgG Rapid Test FDA notified
Bioscience(Chongqing) Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG FDA notified
Diagnostic Technology Co., Antibody
Ltd.
Bioscience(Chongqing) Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM FDA notified
Ltd.
Bioscience(Tianjin) Novel Coronavirus (2019-nCoV) Antibody Rapid Test FDA notified
Diagnostic Technology Co.,
Ltd.
Bioscience(Tianjin) Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG FDA notified
Ltd.
Bioscience(Tianjin) Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM FDA notified
Ltd.
Page 85 of 121
BioSys Laboratories, Inc. BioSys Plus COVID-19 IgM/IgG Rapid Test FDA notified
Boditech Med Inc AFIAS COVID-19 Ab serological tests FDA notified
BTNX, Inc. Rapid COVID-19 IgG/IgM Test Cassette FDA notified

Response™
Calbiotech, Inc. ErbaLisa® COVID-19 IgG FDA notified
Camtech Diagnostics Pte Ltd Camtech COVID-19 IgM/IgG Provisional

authorization
09/04/2020
Cellex Inc (United States Of Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit TGA approved
America) 31/03/2020
Changchun Wancheng Bio- COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold FDA notified
Electron Co., Ltd. immunochromatography)
Chembio Diagnostic DPP COVID-19 IgM/IgG System EUA
Systems, Inc. 14/04/2020
ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test FDA notified
Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test FDA notified
Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test FDA notified
Coronacide™ COVID-19 IgM/IgG Rapid Test FDA notified
CTK Biotech CTK Biotech, Inc., OnSite COVID-19 IgG/IgM Rapid Test TGA approved FDA notified
19/03/2020
DIALAB(ZJG) Biotech Co., SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay) FDA notified
Ltd.
DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG FDA notified
Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit FDA notified
Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit FDA notified
Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test FDA notified
Dynamiker Biotechnology RapidCOV™ 2019-nCOV IgG/IgM Rapid Test FDA notified

(Tianjin) Co., Ltd.
Eachy Biopharmaceuticals AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow FDA notified
Co., Ltd. Immunoassay)
Page 86 of 121
Eachy Biopharmaceuticals SmartScreen COVID-19 IgM/IgG Test Kit FDA notified

Co., Ltd.
Enable Biosciences Inc. ADAP SARS-CoV-2 Total Antibody Assay FDA notified
EpiGentek SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit FDA notified
Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit FDA notified
Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit FDA notified
ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay FDA notified
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) FDA notified
EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) FDA notified
Everest Links Pte Ltd / VivaDiag™ COVID-19 IgM/IgG Rapid Test TGA approved Provisional FDA notified
VivaChek Biotech 26/03/2020 authorization
(Hangzhou) Co., Ltd. 20/03/2020
Fosun Pharma USA Inc. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit FDA notified
GenBody Inc. GenBody COVID-19 IgM/IgG TGA approved FDA notified

28/04/2020
GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit FDA notified
GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit FDA notified
Genlantis Diagnostics, Inc. CovidQuik™ Coronavirus (COVID-19) IgM/IgG Antibody Test FDA notified
Genobio Pharmaceutical Co., COVID-19 IgM/IgG Lateral Flow Assay FDA notified
Ltd.
Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) FDA notified
Getein Biotech Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody FDA notified
(Colloidal Gold)
Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM kit FDA notified
Grit Overseas Pte Ltd DiagnoSure COVID-19 IgG/ IgM Rapid Test Cassette Provisional
authorisation
24/04/2020
Guangdong Hecin Scientific, SARS-CoV-2 IgM Antibody Rapid Test Kit FDA notified
Inc.
Page 87 of 121
Guangzhou Fenghua SARS-CoV-2 IgG/IgM Rapid Test FDA notified

Bioengineering Co., Ltd.
Guangzhou Wondfo Biotech SARS-CoV-2 Antibody Test TGA approved Provisional FDA notified
Co., Ltd. / SkyQuest Pte Ltd. 25/03/2020 authorization
09/04/2020
Hangzhou AllTest Biotech AllTest 2019-nCoV IgG/IgM Rapid Test Cassette FDA notified
Co., Ltd.
Hangzhou AllTest Biotech AllTest COVID IgG/IgM Rapid Test Dipstick FDA notified
Co., Ltd.
Hangzhou Biotest Biotech COVID-19 IgG/IgM Rapid Test Cassette TGA approved FDA notified
23/03/2020
Hangzhou Clongene Biotech COVID-19 IgM/IgG Rapid Test Cassette TGA approved FDA notified
Co., Ltd. Clungene 26/03/2020
Hangzhou Laihe Biotech Co Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit TGA approved
Ltd (China) (Colloidal Gold) 06/04/2020
Hangzhou Realy Tech Co 2019-nCOV IgG/IgM Rapid Test TGA approved FDA notified
Ltd. 16/04/2020
Hangzhou Testsealabs One Step SARS-CoV2 (COVID-19) IgG/IgM Test FDA notified
Biotecnology Co.
Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) TGA approved FDA notified
29/04/2020
H-Guard (China) Co., Ltd. Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) FDA notified
HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test FDA notified
Hunan RunKun SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold) FDA notified
Pharmaceutical Co., Ltd
IMMY, Inc. clarus SARS-CoV-2 Total Antibody EIA FDA notified
INNOVITA (Tangshan) 2019-nCoV Ab Test (Colloidal Gold) TGA approved FDA notified
Biological Technology Co., 04/04/2020
Ltd.
Jiangsu Dablood AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test FDA notified
Pharmaceutical Co, Ltd.
Jiangsu Dablood COVID-19 IgM/IgG Rapid Test FDA notified
Pharmaceutical Co. Ltd.
Jiangsu Macro & Micro-Test SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold) FDA notified
Med-Tech Co., Ltd.
Page 88 of 121
Jiangsu Superbio Biomedical DualTec SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection FDA notified
(Nanjing) Co., Ltd. Kit (Colloidal Gold)
Jiangsu Superbio Biomedical SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit FDA notified
(Nanjing) Co., Ltd. (Colloidal Gold)
Jiangsu Superbio Biomedical ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast FDA notified
(Nanjing) Co., Ltd. Detection Kit (Colloidal Gold)
Jiangsu Well Biotech Co., COVID-19 IgM/IgG Rapid Test (Colloidal Gold) FDA notified
Ltd.
Lepu Medical Technology Lepu SARS-CoV-2 Antibody Test (colloidal gold FDA notified
(Beijing) Co., Ltd. immunochromatography)
Lifeassay Diagnostics (Pty) Test-it COVID-19 IgM/IgG Lateral Flow Assay FDA notified
Ltd
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test FDA notified
LumiQuick Diagnostics, Inc., QuickProfile™ 2019-nCoV IgG/IgM Antibody Test FDA notified
Maccura Biotechnology Co., Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) FDA notified
Ltd. IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Medical Systems Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit FDA notified
Biotechnology Co., Ltd.
MedMira Inc. REVEALCOVID-19™ Total Antibody Test FDA notified
Mokobio Biotechnology R&D SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay FDA notified
Center
Mokobio Biotechnology R&D COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay) FDA notified
Center Inc
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test FDA notified
Nanjing Liming Bio-products SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit FDA notified
Co.,Ltd
Nanjing SYNTHGENE Medical SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold FDA notified
Technology Co., Ltd. Method)
Nanjing Vazyme Medical 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) FDA notified
Technology Co., LTD.
NanoResearch, Inc. SARS-COV-2 IgM/IgG Antibody Rapid Test FDA notified
NanoMedicina™
Nantong Diagnos (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) FDA notified
Biotechnology Co., Ltd.
Page 89 of 121
Nantong Egens EGENS COVID-19 IgG/IgM Rapid Test Kit FDA notified
Biotechnology Co., Ltd
Naturitious LLC Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT FDA notified
Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit FDA notified
Ortho Clinical Diagnostics, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent FDA notified
Inc. Pack
Ortho-Clinical Diagnostics, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent FDA notified
Inc. Pack
Ortho-Clinical Diagnostics, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent FDA notified
Inc. Pack and Calibrator
PCL Inc. COVID19 IgG/IgM Rapid Gold FDA notified
PerGrande BioTech SARS-CoV-2 Antibody Detection Kit (Colloidal Gold FDA notified
Development Co., Ltd. Immunochromatographic assay)
Phamatech Inc. COVID19 IgG/IgM Rapid Test FDA notified
Promedical COVID-19 Rapid Test (Wondfo SARS-CoV-2 Antibody Test (Lateral FDA notified
Flow Method))
Promedical Equipment Pty Promedical IgM/IgG Rapid Detection Kit FDA notified
Ltd
Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal FDA notified
Gold
Qingdao Hightop Biotech Co SARS-CoV-2 IgM/lgG Antibody Rapid Test TGA approved
Ltd (China) 31/03/2020
Qingdao Hightop Biotech HIGHTOP 2019-nCoV IgM/IgG Rapid Test FDA notified
Co., Ltd.
RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit FDA notified
(Colloidal Gold Method)
RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit FDA notified
(Colloidal Gold Method)
Reszon Diagnostics RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test FDA notified
International Sdn. Bhd.
Safecare Biotech (Hangzhou) SAFECARE COVID-19 IgG/IgM Rapid Test Device FDA notified
Co., Ltd
Saladax Biomedical Inc. COVID-19 IgG/IgM Rapid Antibody Test FDA notified
Saladax
Page 90 of 121
SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo FDA notified
Shanghai Eugene Biotech SARS-CoV2 (COVID-19) IgG/IgM Rapid Test FDA notified
Co., Ltd.
Shanghai Liangrun Liangrun COVID-19 IgM/IgG Antibody Test FDA notified
Biomedicine Technology Co.,
Ltd.
Shanghai Outdo Biotech Co., Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test FDA notified
Ltd.
Shenzhen Landwind Medical COVID-19 IgG/IgM Rapid Test Device FDA notified
Co., Ltd
Shenzhen Lvshiyuan COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit FDA notified
Biotechnology Co., Ltd
Shenzhen Watmind Medical SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit FDA notified
Co.
Singuway Biotech Inc. COVID-19 IgG/IgM Detection Kit (Colloidal Gold) FDA notified
Sinocare, Inc. SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method) FDA notified
Spring Health Care AG COVID-19 IgG/IgM Rapid Test Cassette (Whole FDA notified
Blood/Serum/Plasma)
Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG FDA notified
Sure Bio-tech API Covid-Rapid IgM/IgG Antibody Test Kit FDA notified
Suzhou Kangheshun Medical SARS-CoV-2 IgG/IgM Rapid Test Cassette FDA notified
Technology Co., Ltd
Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test FDA notified
Tianjin Beroni Biotechnology SARS-CoV-2 IgG/IgM Antibody Detection Kit FDA notified
Co. Ltd
Tianjin New Bay Bioresearch Quikpac II COVID-19 IgG/IgM FDA notified
Co., Ltd.
Türklab Tibbi Malzemeler SARS-CoV-2 IgM/IgG Ab Test FDA notified
San. ve Tic. A.Ş. INFO
Türklab Tibbi Malzemeler SARS-CoV-2 IgM/IgG Ab Test FDA notified
San. ve Tic. A.Ş. TOYO
UC Berkeley Innovative [No name given] FDA notified
Genomic Institute
Page 91 of 121
United Biomedical, Inc. SARS-CoV-2 ELISA FDA notified

UBI®
VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette FDA notified
COVID-19 IgG/IgM Rapid
test Cassette
Virotech Diagnostics SARS-CoV-2 IgA ELISA Test Kit FDA notified
GmbH Gold Standard
Diagnostics
Virotech Diagnostics SARS-CoV-2 IgG ELISA Test Kit FDA notified
GmbH Gold Standard
Diagnostics
Virotech Diagnostics SARS-CoV-2 IgM ELISA Test Kit FDA notified
GmbH Gold Standard
Diagnostics
VITA Testing COVID-19 IgM / IgG Antibody Rapid Test Kit FDA notified
(Immunochromatography)
W.H.P.M. Inc., COVID-19 IgM/IgG Rapid Test FDA notified
W.H.P.M. Inc., COVISURE™ COVID-19 IgM/IgG Rapid Test FDA notified
Wuhu 3H Biotechnology Co. COVID-19 IgG/IgM Test Kit (Colloidal Gold Method) FDA notified
Ltd.
Xiamen AmonMed Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) FDA notified
Biotechnology Co. Ltd
Zhejiang GENE SCIENCE Co., Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit FDA notified
Ltd (Latex Chromatography)
Zhejiang Orient Gene COVID-19 IgG/IgM Rapid Test Cassette TGA approved FDA notified
Biotech, Co., Ltd. 01/04/2020
Zhengzhou Fortune COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold FDA notified
Bioscience Co., Ltd. Immunochromatography method)
Zhengzhou Fortune COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold FDA notified
Zhengzhou Fortune COVID-19 Antibody Rapid Test Kit (Colloidal Gold FDA notified
Zhongshan Bio-Tech Co. Ltd SARS-CoV-2 IgM/IgG (GICA) FDA notified
Zhuhai Encode Medical Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device FDA notified
Engineering Co., Ltd
Page 92 of 121
Zhuhai Keyu Biological SARS-CoV-2 IgG/IgM Rapid Test Kit FDA notified
Engineering Co., Ltd.
Zhuhai Livzon Diagnostics, Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) TGA approved FDA notified
Inc. Diagnostic Kit for (Colloidal Gold) 23/04/2020
IgM/IgG
Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method) FDA notified
Other tests – Microarray tests
Veredus Laboratories Pte Ltd VereCoV™ Detection Kit Provisional

authorization
18/02/2020
Other tests – Isothermal
Biowalker Pte Ltd Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Provisional
Amplification-Real Time Fluorescence Assay) authorization
24/03/2020
NOTE: Data were compiled through review of the government websites for the five jurisdictions.(108-112) Data are accurate as of 29 April 2020, 07.30 GMT.
Page 93 of 121
Table A.2 Diagnostic tests for which CE-marking is claimed*
Manufacturer Diagnostic Test

Molecular tests
1drop Inc. 1copy COVID-19 qPCR Multi Kit
3D Medicines 3DMed 2019-nCoV RT-qPCR Detection Kit
3D Medicines AndiS SARS-CoV-2 RT-qPCR Detection Kit
3D Medicines AndiS SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit
AB Analitica REALQUALITY RQ-2019-nCoV
Abbott Molecular Abbott RealTime SARS-CoV-2 assay
Access Bio, Inc. CareStart COVID-19 MDx RT-PCR
Accuster Technologies Pvt Ltd Accuster SARS-COV2-RT-PCR test kit
Acumen Research Laboratories Acu-Corona 2.0/3.0
ADALTIS srl MOLgen SARSCoV2 Real Time RT PCR
Advanced Molecular Diagnostics Zena Max-SARS-CoV-2 RT-PCR detection
AITbiotech abTES COVID-19 qPCR I Kit
Amoy Diagnostics Co., Ltd AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit
Amplicon Ltd AmpliTest SARS-CoV-2 (Real Time PCR)
Anatolia Geneworks Bosphore Novel Coronavirus (2019-Ncov) Detection Kit
Anhui Anlong Gene Technology Co., Ltd Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR)
AniCon Labor GmbH Kylt SARS-CoV-2 Confirmation RT-qPCR
AniCon Labor GmbH Kylt SARS-CoV-2 Screening RTU RT-qPCR
Anlong Gene 2019-nCoV nucleic acid (Fluorescence PCR)
Anlongen nConV-19 Nucleic Acid qPCR Kit
Appolon Bioteck Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)
AssayGenie COVID-19 CE IVD qPCR assay
Atlas Medical Atlas COVID-19 Real Time RT-PCR Kit
AusDiagnostics AusDiagnostics respiratory virus panel (including SARS-CoV-2) test
Bag Diagnostics Viro-Q SARS-CoV-2 kit
Bai-care (Tianjin) Biotechnology Co., Ltd Multiplex Nucleic Acid Detection Kit for Respiratory Pathogens
Beijing Applied Biological ORF1ab Gene Triple Fluor. PCR
Beijing Applied Biological Technologies Co., Ltd Multiple Real-Time PCR Kit for Detection of 2019-nCoV
Beijing Hotgen Biotech Co., Ltd Coronavirus disease(COVID-19) Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen ELISA Test Kit
Page 94 of 121

Beijing Microread Genetics Co.,Ltd COVID-19 (SARS-CoV-2) Detection Kit (LAMP) - lab-based or near-POC
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit
BGI (Pathomics Health as distributor) Real-Time Fluorescent RTPCR Kit for Detecting SARS-2019-nCoV
Bioeksen R&D Technologies Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit
BioMaxima SARS-CoV-2 Real Time PCR LAB-KIT
BioMérieux SARS-COV-2 R-GENE test
Bioneer AccuPower COVID-19 Real-Time RT-PCR Kit
Biotech & Biomedicine (Shenyang) Group Ltd Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus
Biotech & Biomedicine (Shenyang) Group Ltd Real Time PCR Detection Kit For COVID-19 Coronavirus
Cancer Rop Co., Ltd. Q-Sens 2019-nCoV Detection Kit
CerTest Biotec, S.L. VIASURE SARS-CoV-2 Real Time PCR Detection Kit
CerTest Biotec, S.L. VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit
Chaozhou Hybribio Biochemistry Ltd COVID-19 Real-Time PCR Kit
Clonit quanty-CONV-19
Co-Diagnostics Logix Smart COVID-19 Test (RT-PCR)
Credo Diagnostics Biomedica VitaPCR SARS-CoV-2 Assay
CTK Biotech, Inc. Aridia COVID-19 Real Time PCR Test
Daan Diagnostics Novel Coronavirus (2019-nCoV) Real Time Multiplex PCR
Dermoaroma Italy Srl D-Biotech: Real-time RT-PCR Detection Kit for COVID-19
DiaCarta QuantiVirus SARS-CoV-2
Diagen Biotechnologic Systems Inc. SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-gene) OneStep R
Diagnostics for the Real World Ltd SAMBA II COVID-19 Test (near-POC NAT)
DiaSorin Molecular, LLC Simplexa COVID-19 Direct RT-PCR Kit
Diatheva SRL COVID-19 PCR DIATHEVA Detection kit
Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Real-Time PCR Testing Kit
Elisabeth Pharmacon spol. s.r.o. EliGene COVID19 BASIC A RT
ELITech Group GeneFinder COVID-19 Plus RealAmp Kit
Eryigit Endustriyel Makina ve Tibbi Cihazlar Senteligo Covid-19 qRT PCR Detection Kit
Eurobio Scientiffic EurobioPlex SARS-CoV-2 Multiplex
EUROIMMUN AG/PerkinElmer EURORealTime SARS-CoV-2
Gencurix Inc. GenePro COVID-19 Detection Test
GeneMatrix Inc. NeoPlex COVID-19 Detection Kit
GeneMe Advanced One Step FAST Covi19 KIT Two Genes Set
Page 95 of 121

General Biologicals Corporation GB SARS-CoV-2 Real Time RT-PCR
GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent
Generi Biotech s.r.o. gb Sarbeco N (primary test)
Generi Biotech s.r.o. gb SARS-CoV-2 RdRP (confirmation test)
Genetic Signatures Ltd EasyScreen SARS-CoV2 Detection Kit
Genetron Health Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing)
GenomCan Inc. Fluorescent PCR Probe Detection Kit for SARS-CoV-2
Genomica CLART COVID-19
Genomica qCOVID-19
Genomictree, Inc. AccuraTect RT-qPCR SARS-CoV-2
Gerbion GmbH & Co., KG VirellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0
Getein Biotech, Inc. Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit
Hangzhou Deangel Biological Engineering Co., Ltd Novel Coronavirus S Glycoprotein Detection Kit
Hangzhou Dian Biotechnology Co., Ltd Real-time RT-PCR Detection Kit For 2019-nCoV
Instituto de Medicina Genómica Imegen SARS-CoV-2
JN Medsys Pte Ltd ProTect COVID-19 RT-qPCR Kit
Kewei Diagnostics Std M nCoV Real Time Kit
KH Medical RADI COVID-19/COVID-19 Triple Detection
Kogene Biotech PowerChek 2019-nCoV Real-time PCR Kit
KRISHGEN BioSystems SARS-CoV-2 (Covid-19) Real-Time PCR Kit
Krosgen Biotech KrosQuanT SARS-COV- 2 (2019 nCOV) Real-time PCR Kit
LabGenomics Co., Ltd LabGun COVID 19 Assay PCR Kit
LG Chem Life Sciences Company AdvanSure COVID-19 real-time RT-PCR
Liming Bio-Products Co., Ltd SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit
Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCoV) Dual-Detection Kit
Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method)
Maccura Biotechnology Co., Ltd SARS-CoV-2 Nucleic Detection Kit (Fluorescent PCR)
Medical Innovation Ventures Sdn Bhd. GenoAmp Real-Time RT-PCR SARS-CoV-2
Medical System Coronavirus PCR test
Medigen Vaccine Biologics Corp. MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit
MicroBioMed Veri-Q PCR 31 COVID-19 POC test
Mikrogen GmbH AmpliCube Coronavirus SARS-CoV-2
Mobidiag Amplidiag COVID-19
Page 96 of 121

Nanjing Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
Next Pharma Inc. DiaCarta's QuantiVirusSARS-CoV-2 Test
Novacyt/primerdesign Genesig Real-Time PCR COVID-19
Optolane Technologies Inc. Kaira 2019-nCoV Detection kit
OsangHealthcare GeneFinder COVID-19 Plus RealAmp Kit
PathoFinder RealAccurate Quadruplex Corona-plus PCR Kit
PCL Inc. PCLMD nCoV one step RT-PCR Kit
PerkinElmer Inc. PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay
PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit
Pishtaz Teb Diagnostics COVID-19 One-Step COVID-19 RT-PCR Kit
Primerdesign Ltd. COVID-19 genesig Real-Time PCR assay
Progenie Molecular S.L.U. RealCycler CORO
QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel
Qingdao Funuo Biomedical Co., Ltd COVID-19 Multiplex Fluorescent PCR Kit
Quidel Corporation Lyra SARS-CoV-2 Assay
Roche Cobas SARS-CoV-2 Test
Sacace Biotechnologies SARS-CoV-2 Real-
Saladax Biomedical Inc. Fosun COVID-19 RT-PCR Detection Kit
Sansure Biotech, Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Schweitzer Biotech Company Ltd SBC SARS-CoV-2 qPCR Kit
SD Biosensor Inc. STANDARD M nCoV Real-Time Detection Kit
SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit
Seegene, Inc. Allplex 2019-nCoV assay
Sente Biolab Senteligo Covid-19 qRT PCR Detection Kit
Sentinel CH STAT-NAT Covid-19 HK and STAT-NAT Covid-19 B
Shaanxi Lifegen Co., Ltd Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method)
Shanghai Fosun Long March Medical Science/Shanghai Novel coronavirus nucleic acid detection kit
Fosun Pharmaceutical
Shanghai ZJ Bio-Tech Co., Ltd/Liferiver Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit
Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR)
Shenzhen Puruikang Biotech Co., Ltd Detection Kit for 2019-Novel Coronavirus RNA (RT-PCR-Fluorescence Probing)
Shenzhen Tailored Medical Ltd New Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Siemens Healthineers Fast Track Diagnostics (FTD) SARS-CoV-2 Assays
Page 97 of 121

Solgent Co.Ltd DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit
Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit
Tellgen Corporation SARS-CoV-2 Nucleic acids detection kit based on Real-Time PCR platform
Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
TIB Molbiol Syntheselabor Sarbecovirus E-gene
Trivitron Healthcare Pvt. Ltd NATSure COVID-19 SinglePlex Real-time PCR Kit
Trivitron Healthcare Pvt. Ltd RNAsure RNA Extraction Kit
Vazyme Medical 2019-Novel Coronavirus Triplex RT-qPCR Kit
Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test
Veredus Laboratories Pte Ltd VereCoV Detection Kit and VerePLEX Biosystem
Viet A Technology Corporation LightPower iVASARS-CoV-2 1st RT-rPCR Kit
Vircell, S.L. SARS-CoV-2 RealTime PCR kit
Vision Medicals SARS-CoV-2 Clinical Sequencing assay
Vitassay Healthcare S.L. Vitassay qPCR SARS-CoV-2
Vitro SA SARS-CoV-2 RT-PCR
Wells Bio, Inc. careGENE COVID-19 RT-PCR kit
Wuhan Easydiagnosis Biomedicine Co., Ltd SARS-CoV-2 nucleic acid test kit
Wuhan HealthCare Biotechnology Co., Ltd Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit
Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit
Xi'an Goldmag Nanobio Tech Co., Ltd Real-Time RT-PCR assays for the detection of SARS-CoV-2
YD Diagnostics Corp. MolecuTech Real-Time COVID-19
Yeastern Biotech (GeneOne) GeneOne COVID-19 Nucleic Acid Diagnostic Kit
Zybio, Inc. SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Antibody tests
AccuBioTech Co. Ltd Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette
Accuster Technologies Pvt Ltd COVID-19 RAPID IgG/IgM test kit
Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test
AlphaBioLabs AlphaBiolabs IgM-IgG Combined Antibody Rapid Test
AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit
AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus IgM combo test kit
Anhui Deep Blue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit
Anomalous Materials Pte Ltd 2019-nCoV IgG/IgM Rapid Testing Kit
Page 98 of 121

Assay Genie (UK) ACE II Activity Assay Kit COVID-19
Assay Genie (UK) COVID-19 Rapid POC (Point-of-Care) kit
Assure Tech (Hangzhou) Co., Ltd. COVID-19 IgG/IgM Rapid Test Device
Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette
Atlas Medical Atlas COVID-19 IgM Elisa Kit
Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit
Aytu BioScience (China) COVID-19 IgG/IgM Rapid Test
Beijing Abace Biology Co., Ltd COVID-19 Antibody (IgG/IgM)Test Kit (Colloidal Gold Immunochromatography)
Beijing Abace Biology Co., Ltd COVID-19 IgG Antibody Test Kit (ELISA)
Beijing Abace Biology Co., Ltd COVID-19 IgM Antibody Test Kit (ELISA)
Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG Antibody Determination Kit
Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgM Antibody Determination Kit
Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold)
Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay)
Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG ELISA Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Fluorescence)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgM ELISA Test Kit
Beijing Lepu Medical Technology Co., Ltd SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)
Beijing Tigsun Diagnostics Co. Ltd Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method)
Beijing Wantai Biologicalpharmacy Enterprise Co Ltd Wantai SARS-CoV-2 Ab Rapid Test Kit
Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test
BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)
Biolidics Ltd 2019-nCoV IgG/IgM Antibody Detection Kit
BIOMAXIMA S.A. 2019-nCoV IgG/IgM Rapid Test Cassette
BioMedomics, Inc./Jiangsu Medomics Medical COVID-19 IgM-IgG Dual Antibody Rapid Test
Technology
Bio-Rad Laboratories Inc. Platelia SARS-CoV-2 Total Ab
Page 99 of 121

Biosino Bio-Technology and Science Inc SARS-COV-2 Antibody Test
BIOSYNEX SA BIOSYNEX COVID-19 BSS
Calbiotech, Inc. ErbaLisa COVID-19 IgG ELISA
Camtech Diagnostics Pte Ltd Camtech COVID-19 IgM/IgG Rapid Test Kit
Cellex Inc. Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test
Changsha Sinocare Inc. SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method)
Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
CTK Biotech OnSite COVID-19 IgG/IgM Rapid Test
DIA PRO Diagnostic BioProbes Srl COV19G.CE - ELISA COVID 19 IgG
DIA PRO Diagnostic BioProbes Srl COV19M.CE - ELISA COVID 19 IgM
DIA.PRO Diagnostic Bioprobes Srl COV19CONF.CE - ELISA COVID 19 IgG Confirmatory
DRG International, Inc. COVID-19 lgG, EIA-6146
DRG International, Inc. COVID-19 lgM, EIA-6147
Dynamiker Biotechnology (Tianjin) Co., Ltd. RapidCOV 2019-nCOV IgG/IgM Rapid Test
Edinburgh Genetics COVID-19 Colloidal Gold, IgG/IgM Combined
Epitope Diagnostics, Inc. EDI Novel Coronavirus COVID-19 IgG ELISA Kit
Epitope Diagnostics, Inc. EDI Novel Coronavirus COVID-19 IgM ELISA Kit
Erba Mannheim ErbaLisa COVID-19 ELISA kits
EUROIMMUN AG/PerkinElmer Anti-SARS-CoV-2 ELISA (IgA)
EUROIMMUN AG/PerkinElmer Anti-SARS-CoV-2 ELISA (IgG)
EUROIMMUN AG/PerkinElmer Anti-SARS-CoV-2 ELISAs (IgA and IgG)
GA Generic Assays GmbH GA CoV-2 IgG/IgM/IgG+
GenBody, Inc. GenBody COVID-19 IgM/IgG
Genitech NSAN Pharmaceutical Pvt. Ltd COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
GenSure Biotech Inc. GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002)
GenSure Biotech Inc. GenSure COVID-19 IgM Rapid Test (REF: P2001)
Getein Biotech Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Gold Standard Diagnostics/Eurofins Technologies NovaLisa SARS-CoV-2 (US: GSD SARS-CoV-2) IgG, IgM, IgA assays
Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM kit
Page 100 of 121


Guangzhou Wondfo Biotech Co., Ltd./SkyQuest Pte Ltd. SARS-CoV-2 Antibody Test
Hanghzhou AllTest Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette
Hangzhou Clongene Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test
Hangzhou Laihe Biotech Co., Ltd LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
Hecin Scientific, Inc. COVID-19 IgM Antibody Rapid Test Kit
Humasis Co., Ltd. Humasis COVID-19 IgG/IgM Test
Hunan Lituo Biotechnology Co., Ltd COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
Ideal Tashkhis Atieh Co. SARS-CoV-2 IgG ELISA Kit
Ideal Tashkhis Atieh Co. SARS-CoV-2 IgM ELISA Kit
INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
Innovita Biological Technology Co. Ltd 2019-nCoV Antibody Test (Colloidal Gold), IgM/IgG Combo
InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) Test
Jetta Labs LLP OZO Diamond SARS-CoV2 (COVID-19) lgG/lgM Test (Latex Method)
Jetta Labs LLP OZO India SARS-CoV2 (COVID-19) lgG/lgM Test (Colloidal Gold Method)
Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit
JinHuan Medical Instrument Co., Ltd (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test
Labnovation Technologies Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test
LOMINA AG SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit
LumiQuick Diagnostics Inc. QuickProfile 2019-nCoV IgG/IgM Combo Test Card
Medical Systems Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
MedicalSystem Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Cassette
Mobidiag (in collaboration with Autobio Diagnostics) Anti-SARS-CoV-2 Rapid Test
Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
Mologic (partnership with the Institut Pasteur de Dakar) Lateral flow immunoassay for detection of antibodies for SARS-CoV-2
MP Biomedicals MP Rapid 2019-nCoV IgG/IgM
Nal von Minden GmbH Nadal COVID-19 IgG/IgM Test (243003N-25, 243002N-20, 243001N-10)
NanoEntek Inc. FREND COVID-19 IgG/IgM Duo
Page 101 of 121


Nantong Egens Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Nantong Egens Biotechnology Co., Ltd EGENS COVID-19 IgG/IgM Rapid Test Kit
NovaTec Immundiagnostica GmbH NovaLisa COVID-19 (SARS-CoV-2) IgA
NovaTec Immundiagnostica GmbH NovaLisa COVID-19 (SARS-CoV-2) IgG
NovaTec Immundiagnostica GmbH NovaLisa COVID-19 (SARS-CoV-2) IgM
NTBio Diagnostics Inc. COVID-19 IgG/IgM Antibody Test Cassette
PCL Inc. COVID19 IgG/IgM Rapid Gold
PerGrande BioTech Development Co., Ltd SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)
PharmaAct AG COVID-19 rapid test
Pishtaz Teb Diagnostics SARS-CoV-2 IgG ELISA Kit
Pishtaz Teb Diagnostics SARS-CoV-2 IgM ELISA Kit
PRIMA Lab S.A. PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use)
Quick Energy Technologies Limited MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay)
RapiGEN Inc. BIOCREDIT COVID-19 IgG+IgM Duo
RayBiotech Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold)
RayBiotech, Inc. Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)
Ring Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Kit
RPC Diagnostic Systems Anti-SARS-CoV-2 enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19)
SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo
SensingSelf, Pte, Ltd, Singapore COVID-19 Rapid IgG/IgM Combined Antibody Assay Pre-screening Test Kit (Model ERCSS05401)
servoprax GmbH Cleartest Corona, Covid-19
Shandong ThinkLab Biotechnology Co., Ltd 2019-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay)
Shanghai Chemtron Biotech Co. Ltd 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold)
Shanghai Outdo Biotech Co., Ltd Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold)
Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ab(IgG/IgM) GICA Rapid Test Kit (Gold Colloidal Immunoassay)
Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold)
Shenzhen LeafMed Technology Ltd Coronavirus COVID-19(SARS-CoV-2) IgM/IgG Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Shenzhen Tailored Medical Ltd Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody Assay Kit (Colloidal Gold Method)
Page 102 of 121


Shenzhen Tisenc Medical Device (collaboration with 2019 Novel Coronavirus IgM kit (CLIA)
Shenzhen University and Shenzhen No.3 People’s
Hospital)
Shenzhen Tisenc Medical Device (collaboration with 2020 Novel Coronavirus IgG kit (CLIA)
Shenzhen University and Shenzhen No.3 People’s
Hospital)
Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgG
Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM
Shenzhen Zhenrui Biotech Co., Ltd COVID-19 IgGg/IgM Rapid Test Cassette (WB/S/P)
Sichuan Xincheng Biological Co., Ltd SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method
Snibe Co., Ltd (Shenzhen New Industries Biomedical MAGLUMI 2019-nCoV IgG (CLIA)
Engineering Co., Ltd)
Snibe Co., Ltd (Shenzhen New Industries Biomedical MAGLUMI 2019-nCoV IgM (CLIA)
Engineering Co., Ltd)
Snibe Diagnostic Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits
Spring Healthcare Services AG COVID-19 IgG/IgM Rapid Test (colloidal gold-based)
Sugentech, Inc. SGTi-flex COVID-19 IgG
Sugentech, Inc. SGTi-flex COVID-19 IgM
Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG
Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgG Ab Rapid Test
Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM Ab Rapid Test
Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM/IgG Ab Rapid Test
Sure Bio-tech API Covid-Rapid IgM/IgG Antibody Test Kit
Surescreen Diagnostics (UK) Covid-19 IgM/IgG Test cassette
Syrona Limited COVID-19 IgG/IgM Rapid Test Cassette
Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgG
Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgM
Tauschen Int. Ltd (Tauschen Groups) COVID - 19 RAPID TEST KIT / Antibody IgG& IgM Test Kit
Tianjin Era Biology Technology Co., Ltd COVID-19 IgG Lateral Flow Assay
Tianjin Era Biology Technology Co., Ltd COVID-19 IgM Lateral Flow Assay
Tianjin Era Biology Technology Co., Ltd COVID-19 IgM/IgG Lateral Flow Assay
Tianjin MNCHIP Technologies Co., Ltd Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay)
Page 103 of 121


U2USystems (India) Pvt. Ltd 2019-ncoV IgG/IgM Test
Vircell S.L. COVID-19 ELISA IgG
Vircell S.L. COVID-19 ELISA IgM+IgA
Vircell S.L. COVID-19 VIRCLIA IgG MONOTEST
Vircell S.L. COVID-19 VIRCLIA IgM+IgA MONOTEST
VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag COVID-19 IgM/IgG Rapid Test
Willi Fox GmbH Willi Fox Covid-19 IgM/ IgG rapid test
Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgG antibody test kit (colloidal gold method)
Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgM antibody test kit (colloidal gold method)
Wuhan UNscience Biotechnology Co., Ltd Covid-19 IgG/IgM Antibody Rapid Test Kit
Xiamen Biotime Biotechnology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit
Xiamen Boson Biotech Co. Ltd Rapid 2019-nCoV IgG/IgM Combo Test Card
Xiamen Wiz Biotech Co. Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2
Yuno Diagnostics Co., Ltd Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits
Zhejiang Gene Science Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit
Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgG ELISA test
Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgM ELISA test
Zhuhai Livzon Diagnostics Inc. Diagnostic Kit for IgM Antibody to Corona Virus(nCoV-2019) (Colloidal Gold)
Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)
IgM/IgG
Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)
Other tests – Antigen tests
AmonMed Biotechnology Co., Ltd COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography)
Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (ELISA)
Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence)
Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Beijing Savant Biotechnology Co., Ltd SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit
Coris BioConcept COVID-19 Ag Respi-Strip
Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Page 104 of 121


Liming Bio-Products Co., Ltd COVID-19 Antigen Rapid Test Device
PCL Inc. PCL COVID19 Ag Rapid FIA
RapiGEN Inc. BIOCREDIT COVID-19 Ag
SD BIOSENSOR, Inc. STANDARD Q COVID-19 Ag Test
SD BIOSENSOR, Inc. STANDARD F COVID-19 Ag FIA
Shenzen Bioeasy 2019-nCoV Colloidal Gold Ag
Shenzen Bioeasy 2019-nCoV Fluorescence Ag Rapid Antigen
Other tests – Microarray assays
PEPperPRINT GmbH PEPperCHIP SARS-CoV-2 Proteome Microarray (manual)
Veredus Laboratories Pte Ltd VereCoV Detection Kit and VerePLEX Biosystem
Other tests – Microfluidic chip
Shenzhen Shineway Technology (collaboration with POCT-PCR
HKUST)
*NOTE: In the absence of a centralised list of verified CE-marked tests, data were compiled through review of four secondary data sources: a report
published by the Saw Swee Hock School of Public Health (report dated 25 April 2020) and the online repositories FIND Dx, 360 Dx, and Rapid
Microbiology.(114-117) The search of online repositories was updated to 30 April 2020. The list comprises products for which a CE mark is claimed. It is not
exhaustive and should not be used for procurement purposes.
The use of online repositories is for illustrative purposes only and is not an endorsement of credibility. Effort has been made to reduce duplication across
information sources, but manufacturer and device names may still be subject to minor error and duplication. Registered trademarks and copyright are not
presented in the table due to contradictory reporting across information sources.
Page 105 of 121

Appendix B – Manufacturer-reported characteristics of SARS-CoV-2 tests

Table B1. Manufacturer-reported characteristics of a selection of NAAT RT-PCR tests for detection of SARS-CoV-2
for which CE marking is claimed
Manufacturer Device name Sample type Target Test Runtime Additional equipment (not provided in test
(country) gene capacity kit)
Anatolia Bosphore Novel Unclear E, ORF1ab Not Not Not specified

Geneworks Coronavirus (2019- specified specified
(Turkey) Ncov) Detection Kit
BGI Europe Real-Time Fluorescent Throat swab, BALF Not Not <3 hours Not specified
(Denmark) RT-PCR kit for detecting specified specified
2019-nCoV (SARS-CoV-
2)
CerTest Biotech VIASURE SARS-CoV-2 Respiratory swab N, ORF1ab Not Not Thermocycler, RNA extraction kit, Centrifuge for 1.5
(Spain) Real Time PCR Detection (nasopharyngeal/ specified specified mL tubes and PCR-well strips or 96-well, Vortex,
Kit oropharyngeal) Micropipettes (0.5-20 µL, 20-200 µL), Filter tips,
Powder-free disposable gloves, Loading block (for
use with Qiagen/Corbett Rotor-Gene® instruments)
Co-Diagnostics Logix Smart COVID-19 LRT (BALF, sputum, RdRp 100 rxn 60-90 Thermocycler, Extraction system, Consumables (e.g.
(US) Test (RT-PCR) tracheal aspirate), URT minutes gloves, lab-coat), Micropipettes (5µL to 1000µL),
(nasopharyngeal fluids, cold block or ice, Vortex and centrifuge, Class II
nasal swab), serum Biosafety cabinet, PCR workstation, Co-Diagnostics
Diagnostics Box (Bio Molecular Systems, distributed
by Co-Diagnostics, Inc.), Thermocycler with
channels capable of detecting FAM and CF610
fluorophores
Credo Diagnostics VitaPCR COVID-19 assay Unclear Not Not 20 minutes Not specified
(Singapore) specified specified
Page 106 of 121

Genomica (Spain) qCOVID-19 Real time Unclear Not 48 1 hr 30 Not specified

Multiplex RT-PCR specified minutes
Genomica (Spain) CLART® COVID-19 Real Unclear Not 80-96 < 5 hours Not specified
time Multiplex RT-PCR specified
Kogene Biotech PowerChek™ 2019-nCoV Unclear E, RdRp Not Not Not specified
(Korea) Real-time PCR Kit specified specified
Liferiver Bio-Tech Novel Coronavirus URT (nasopharyngeal E, N, RdRP Not 35-50 Biological cabinet, Vortex mixer, Cryo-container,
(China) (2019-nCoV) Real Time extracts, deep cough specified minutes Sterile filter tips for micro pipets, Disposable gloves
Multiplex RT-PCR kit sputum) and LRT (BALF) (powderless), Refrigerator and freezer, Real time
specimens PCR system, Real time PCR reaction tubes/plates,
Pipets (0.5μl – 1000μl), Sterile microtubes,
Biohazard waste container, Tube racks, Desktop,
microcentrifuge for “eppendorf” type tubes
OSANGHealthcare GeneFinderTM COVID- Respiratory samples E, N, RdRp Not <3 hours Applied Biosystems® 7500 / 7500 Fast Real Time
(Korea) 19 Plus RealAmp Kit (BALF, nasopharyngeal/ specified PCR Instrument System and CFX96 real time PCR
oropharyngeal swab, system, Pipettes (1- 20 μl, 20-200 μl, 200-1,000 μl),
sputum) Pipettes tips with aerosol barrier (RNase, DNase-
free), Powder-free gloves (disposable), Vortex mixer
or equivalent, 1.5 ml tube, PCR tube or 96 well
plate, Bench microcentrifuge, RNA isolation kit
Primerdesign Ltd Coronavirus (COVID-19) Nasopharyngeal/ Not 96 Unspecified PCR hood, Benchtop centrifuge, Vortex mixer, White
(UK) genesig® Real-Time PCR oropharyngeal swab, specified Roche® LightCycler 480 Multiwell plate 96, White
assay sputum Bio-Rad® CFX96 Multiwell plate 96, Transparent
Applied Biosystems® 7500 Real-Time PCR System
Multiwell Plate 96, Adjustable pipettes, Pipette tips
with filters, Disposable gloves, 1.5ml microcentrifuge
tubes for extraction
Page 107 of 121

Roche Molecular Cobas® SARS-CoV-2 Nasopharyngeal/ E, Orf1a 96 < 3 hours Unspecified

Diagnostics (Real-Time PCR assay) oropharyngeal swab
(Switzerland)
Sansure (China) Novel Coronavirus BALF, nasopharyngeal/ Orf1a, N Not 30 minutes 1.5 mL Dnase-free and Rnase-free centrifuge tubes,
(2019-nCoV) Nucleic oropharyngeal swab, specified 0.2 mL PCR reaction tubes, pipette tips (10 µL, 200
Acid Diagnostic Kit sputum, whole blood, µL and 1000 µL tips with filters are preferred),
feces desktop centrifuge, desktop vortex mixer various
models of pipette gund
SD Biosensor STANDARD M n-CoV Nasopharyngeal/throat E, ORF1ab, Not 90 minutes Unspecified

(Korea) Real-Time Detection Kit swabs, sputum RdRp specified
for emergency COVID-
19 test
Seegene (Korea) Allplex™ 2019-nCoV BALF, E, N, RdRp Not 110 Unspecified

Assay nasopharyngeal/throat specified minutes
swab/aspirate, sputum (after
extraction)
Solgent DiaPlexQ™ Novel Nasopharyngeal/orophar N, Orf1a Not < 2 hours States all reagents included
Coronavirus (2019- yngeal swab, sputum specified
nCoV) Detection Kit
Vircell (Spain) SARS-CoV-2 RealTime Respiratory samples Not Not 90 mins Unspecified
PCR kit specified specified
Note: List is limited to a selection of products for which a CE mark is claimed. The list is not exhaustive and should not be used for procurement purposes.
Key: BALF – bronchoalveolar lavage fluid; CE – Conformité Européenne; IVD – in vitro diagnostics; LRT – lower respiratory tract; NAAT – nucleic acid
amplification test; RT-PCR – reverse transcriptase polymerase chain reaction; URT – upper respiratory tract.
Page 108 of 121

Table B2. Manufacturer-reported sensitivity and specificity of a selection of NAAT RT-PCR tests for detection of
SARS-CoV-2 for which CE marking is claimed
Manufacturer Device name Analytical sensitivity Clinical sensitivity (95% Clinical specificity
(country) CI)
Anatolia Geneworks Bosphore Novel Coronavirus (2019-Ncov) Detection Not specified Not reported Not reported
(Turkey) Kit
BGI Europe Real-Time Fluorescent RT-PCR kit for detecting 100 copies/mL Not reported Not reported
2019-nCoV (SARS-CoV-2)
(Denmark)
CerTest Biotech (Spain) VIASURE SARS-CoV-2 Real Time PCR Detection Kit ≥10 RNA copies per 100% (16-100%) 100% (96-100%)
reaction Comparator: Molecular Comparator: Molecular
detection detection
Co-Diagnostics Logix Smart COVID-19 Test (RT-PCR) 9.35x1000 copies/ml 100% (96-100%) 100% (96-100%)
(US)
Credo Diagnostics VitaPCR COVID-19 assay Not specified Not reported Not reported
(Singapore)
Genomica qCOVID-19 Real time Multiplex RT-PCR Not specified 100%* 100%*
(Spain)
Genomica CLART® COVID-19 Real time Multiplex RT-PCR Not specified 96%* 98%*
(Spain)
Kogene Biotech (Korea) PowerChek™ 2019-nCoV Real-time PCR Kit Not specified Not reported Not reported
Liferiver Bio-Tech (China) Novel Coronavirus (2019-nCoV) Real Time Multiplex 1×1000 copies/ml Not reported Not reported
RT-PCR kit
Page 109 of 121

Manufacturer Device name Analytical sensitivity Clinical sensitivity (95% Clinical specificity
(country) CI)
OSANGHealthcare GeneFinderTM COVID-19 Plus RealAmp Kit 10 copies/reaction for all Not reported Not reported
(Korea) target genes
Primerdesign Ltd Coronavirus (COVID-19) genesig® Real-Time PCR 0.58 copies/µl 98% (89-100%) 100% (93-100%)
assay Comparator: Real-time PCR Comparator: Real-time PCR
(UK)
Roche Molecular Cobas® SARS-CoV-2 (Real-Time PCR assay) Not specified Not reported Not reported
Diagnostics (Switzerland)
Sansure Novel Coronavirus (2019-nCoV) Nucleic Acid 200 copies/mL Not reported Not reported
Diagnostic Kit
(China)
SD Biosensor STANDARD M n-CoV Real-Time Detection Kit for Not specified Not reported Not reported
emergency COVID-19 test
(Korea)
Seegene Allplex™ 2019-nCoV Assay 100 RNA copies/rxn URT: 100% (93-100%) URT: 94% (87-98%)
LRT: 100% (93-100%) LRT: 98% (93-100%)
(Korea) Comparator: Real-time PCR Comparator: Real-time PCR
Solgent DiaPlexQ™ Novel Coronavirus (2019-nCoV) Not specified Not reported Not reported
Detection Kit
Vircell SARS-CoV-2 RealTime PCR kit Not specified Not reported Not reported
(Spain)
Key: CI – confidence interval; IVD – in vitro diagnostics; NAAT – nucleic acid amplification test; RT-PCR – reverse transcriptase polymerase chain reaction.
Note: List is limited to a selection of products for which a CE mark is claimed. The list is not exhaustive and should not be used for procurement purposes. All
data are as reported by the manufacturer and have not been independently validated. Diagnostic performance has been rounded to the nearest integer.
* Clinical sensitivity and specificity were reported by the manufacturer, but without underlying clinical data. Therefore, 95% confidence intervals could not be
estimated.
Page 110 of 121

Table B3. Manufacturer-reported characteristics of a selection of antibody tests for detection of SARS-CoV-2 for
which a CE mark is claimed
Manufacturer Device name Sample type Target Sample Runtime Additional equipment (not provided in test
(country) antibody capacity kit)
Assay Genie COVID-19 Rapid POC Whole Blood, serum, IgG, IgM 1 10-15 Specimen collection containers, Lancets (for
(Point-of-Care) kit plasma minutes fingerstick whole blood only), Capillary tubes,
(UK) Centrifuge (for plasma only), Timer, Pipette
Aytu BioScience COVID-19 IgG/IgM Whole blood, serum, IgA, IgG Not 2-10 Unclear
(China) Rapid Test plasma specified minutes
Bioeasy 2019-NOVEL Whole blood, serum, IgG, IgM 1 10-15 Unclear

CORONAVIRUS (2019- plasma minutes
(USA) nCoV) IgG/IgM GICA
RAPID TEST KIT
Biomedomics COVID-19 IgM/IgG Whole blood, serum, IgG, IgM 1 10-15 Capillary Samplers, Lancet, Alcohol Wipes, Gloves,
Rapid Test plasma minutes Timer
(US)
CTK Biotech OnSite COVID-19 Whole blood, serum, IgG, IgM Not 10 minutes Unclear
IgG/IgM Rapid Test plasma specified
(US)
Dynamiker 2019 nCOV IgG/IgM Whole blood, serum, IgG, IgM 1 10 minutes Unclear
Biotechnology Rapid Test plasma
(Tianjin) Co. Ltd
(China)
EUROIMMUN AG ELISA assay for Serum IgG, IgM Not Unclear Unclear
(Germany) detection of Anti SARS- specified
COV-2
Page 111 of 121

Manufacturer Device name Sample type Target Sample Runtime Additional equipment (not provided in test
(country) antibody capacity kit)
InTec Products Rapid SARS-CoV-2 Whole blood, serum or IgG 1 15-20 Unclear
(US) Antibody Test plasma (fingerprick) minutes
InTec Products Rapid SARS-CoV-2 Whole blood, serum or IgG, IgM 1 15-20 Unclear
(US) Antibody (IgM/IgG) Test plasma (fingerprick) minutes
Nal von Minden Nadal COVID-19 Whole blood IgG, IgM 1 Unclear Specimen collection containers (appropriate for
GmbH IgG/IgM Test (test (fingerprick/ specimen material to be tested), Centrifuge (for
cassette) venepuncture), serum, serum or plasma specimens only), Alcohol pads,
(Germany) plasma Lancets (for fingerstick whole blood specimens
only), Timer
Raybiotech Coronavirus (COVID-19) Whole blood IgG, IgM Not 8-10 None
IgM/IgG Rapid Test Kit (fingerprick/ specified minutes
(USA) venepuncture), serum, (reaction
plasma time only)
Snibe Diagnostic Maglumi 2019-nCoV Serum, plasma IgA, IgM Not 30 minutes Unclear
(China) (SARS-CoV-2) IgM/IgG specified
kits
Surescreen Covid-19 IgM/IgG Test Whole blood, serum, IgG, IgM, 1 10-15 Unclear
Diagnostics cassette plasma (fingerprick minutes
possible)
(UK)
Key: IgG – immunoglobulin G; IgM – immunoglobulin M; IVD – in vitro diagnostics.

data are as reported by the manufacturer and have not been independently validated.
Page 112 of 121

Table B4. Manufacturer-reported sensitivity and specificity of a selection of antibody tests for detection of SARS-
CoV-2 for which a CE mark is claimed
Manufacturer (country) Device name Clinical sensitivity (95% CI) Clinical specificity
Assay Genie COVID-19 Rapid POC (Point-of-Care) kit IgG: 100% (83-100%) IgG: 98% (89-100%)
IgM: 85% (62-97%) IgM: 96% (86-100%)
(UK)
Aytu BioScience COVID-19 IgG/IgM Rapid Test IgG: 97% (85-100%) IgG: 100% (77-100%)
IgM: 88% (80-94%) IgM: 100% (77-100%)
(China) Comparator: RT-PCR or clinical diagnosis Comparator: RT-PCR or clinical diagnosis
Bioeasy 2019-NOVEL CORONAVIRUS (2019-nCoV) Not reported Not reported

IgG/IgM GICA RAPID TEST KIT
(USA)
Biomedomics COVID-19 IgM/IgG Rapid Test Dual IgG/IgM: 89% (85-92%) Dual IgG/IgM: 91% (84-95%)
Comparator: Single IgG/IgM Comparator: Single IgG/IgM
(US)
CTK Biotech OnSite COVID-19 IgG/IgM Rapid Test 90% (73-98%)** 100% (89-100%)**
(US)
Dynamiker Biotechnology (Tianjin) 2019 nCOV IgG/IgM Rapid Test 90% (73-98%)** 100% (89-100%)**
Co. Ltd (China)
EUROIMMUN AG ELISA assay for detection of Anti SARS-COV- IgA: 93% (78-99%)** IgA: 93% (85-97%)**
2 IgG: 67% (47-83%)** IgG: 96% (90-99%)**
(Germany)
InTec Products Rapid SARS-CoV-2 Antibody Test 95%* 98%*
(US)
InTec Products Rapid SARS-CoV-2 Antibody (IgM/IgG) Test 94%* 98%*
Page 113 of 121

Manufacturer (country) Device name Clinical sensitivity (95% CI) Clinical specificity
(US)
Nal von Minden GmbH Nadal COVID-19 IgG/IgM Test (test IgG: 98% (93-100%) IgG: 99% (96-100%)
cassette) IgM: 94% (86-97%) IgM: 99% (97-100%)
(Germany) Comparator: RT-PCR or clinical diagnosis Comparator: RT-PCR or clinical diagnosis
Raybiotech (USA) Coronavirus (COVID-19) IgM/IgG Rapid Test Not reported Not reported
Kit
Snibe Diagnostic Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG Not reported Not reported
kits
(China)
Surescreen Diagnostics Covid-19 IgM/IgG Test cassette IgG: 97% (86-100%) IgG: 99% (96-100%)
IgM: 89% (72-96%) IgM: 99% (95-100%)
(UK)
Key: CI – confidence interval; IgG – immunoglobulin G; IgM – immunoglobulin M; IVD – in vitro diagnostics.
data are as reported by the manufacturer and have not been independently validated. Diagnostic performance has been rounded to the nearest integer.
* Clinical sensitivity and specificity were reported by the manufacturer, but without underlying clinical data. Therefore, 95% confidence intervals could not be
estimated.
** According to data reported by Lassaunière et al.(151) who evaluated nine commercial antibody tests available in Denmark for detection of CoV-SARS-2. The
pre-print was not peer-reviewed as of April 15 2020. CTK Biotech reported the clinical sensitivity and specify at 97% and 99%, respectively, but without
presentation of underlying clinical data.
Page 114 of 121

Table B5. Characteristics of a selection of other diagnostic tests for detection of SARS-CoV-2 for which a CE mark is
claimed
Manufacturer Device name Device Target Sample type Sample Turn-around Additional
(country) technology capacity equipment
Bioeasy (USA) 2019-Novel Fluorescence Viral antigen Sputum, Unspecified 10 mins Not specified
Coronavirus immuno- alveolar lavage
(2019-nCoV) chromatographi fluid, nasal
Antigen Rapid c assay swab
test kit
Shenzhen POCT-PCR Microfluidic Viral RNA Unclear 8 samples 40 mins Not specified
Shineway chip (sampling to
Technology testing)
(Hong Kong)
Key: IVD – in vitro diagnostics; PCR – polymerase chain reaction; POCT – point of care test.
data are as reported by the manufacturer and have not been independently validated.
Page 115 of 121

Figure B1. Forest plot of a selection of manufacturer-reported antibody tests for detection of SARS-CoV-2* for
which a CE mark is claimed
data are as reported by the manufacturer and have not been independently validated. Only estimates where manufacturers reported sufficient data are
presented in the forest plot.
* A number of the devices are presented twice because diagnostic accuracy varied according to target antibody (that is, IgG or IgM). Subgroup analysis by
antibody target is presented below.
Page 116 of 121

Figure B2. Forest plot of a selection of manufacturer-reported antibody tests for detection of SARS-CoV-2
(subgroup analysis of tests for IgG detection)* for which a CE mark is claimed
Key: IgG – immunoglobulin G; IgM – immunoglobulin M.

All data are as reported by the manufacturer and have not been independently validated.
* Only estimates where manufacturers reported sufficient data are presented in the forest plot.
Page 117 of 121

Figure B3. Forest plot of a selection of manufacturer-reported antibody tests for detection of SARS-CoV-2
(subgroup analysis of tests for IgM detection)* for which a CE mark is claimed
Key: IgM – immunoglobulin M.

All data are as reported by the manufacturer and have not been independently validated. Only estimates where manufacturers reported sufficient data are
presented in the forest plot.
Page 118 of 121

Published by the Health Information and Quality Authority (HIQA).
For further information please contact:

George’s Court
George’s Lane
Smithfield
Dublin 7
D07 E98Y
Phone: +353 (0) 1 814 7400

info@hiqa.ie
www.hiqa.ie
© Health Information and Quality Authority 2020
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Rapid HTA of alternative diagnostic technologies for the detection of SARS -CoV-2

Health Information and Quality Authority

Rapid health technology

Safer Better Care

About the Health Information and Quality Authority

 Setting standards for health and social care services — Developing

 Regulating social care services — The Chief Inspector within HIQA is

 Regulating health services — Regulating medical exposure to ionising

 Monitoring services — Monitoring the safety and quality of health services

 Health technology assessment — Evaluating the clinical and cost-

 Health information — Advising on the efficient and secure collection and

 National Care Experience Programme — Carrying out national service-

5. Diagnostic tests approved for use internationally ........................................... 52

Members of the Evaluation Team:

Members of HIQA’s Evaluation Team include Dr Patricia Harrington, Paul Carty, Dr

Version Date Description of change

List of abbreviations used in this report

ARTG Australian Register of Therapeutic Goods

CDC Centre for Disease Prevention and Control

cDNA complementary deoxyribonucleic acid

COVID-19 Coronavirus disease 2019

CRISPR clustered regularly interspaced short palindromic repeats

CTS common technical specifications

DNA deoxyribonucleic acid

DTA diagnostic test accuracy

ECDC European Centre for Disease Prevention and Control

ELISA enzyme-linked immunosorbent assays

EUA Emergency Use Authorization

FDA Food and Drug Administration

FSCA field safety corrective actions

HIQA Health Information and Quality Authority

HIV human immunodeficiency virus

HPRA Health Products Regulatory Authority

HSE Health Service Executive

HTA health technology assessment

HZI Helmholtz Centre for Infection Research

ICU intensive care unit

IFA immunofluorescence assays

ILI influenza-like illness

IVD in vitro diagnostics

IVDR In Vitro Diagnostic Regulation

JRC Joint Research Centre

MERS Middle East Respiratory Syndrome

MHRA Medicines and Healthcare products Regulatory Authority

NAAT nucleic acid amplification technology

NPHET National Public Health Emergency Team

RNA ribonucleic acid

RT-LAMP reverse transcription loop-mediated isothermal

RT-PCR reverse transcription polymerase chain reaction

SARI severe acute respiratory infections

SARS-CoV-2 severe acute respiratory syndrome coronavirus 2

SHERLOCK Specific High Sensitivity Enzymatic Reporter UnLOCKing

TGA Therapeutic Goods Administration

WHO World Health Organization

At the request of NPHET, HIQA investigated the potential usefulness of alternative

Potential alternative diagnostic approaches

 pathogen (virus) detection (acute infection)

 detection of immune response to the pathogen (past exposure).

Reverse transcription polymerase chain reaction (RT-PCR) facilitates direct detection