DIAGNOSTIC ASSAYS

& INSTRUMENTS
GOLD STANDARD DIAGNOSTICS EUROPE
2022 INTERNATIONAL CATALOGUE
Index

About Us 02

ELISA Kits 03

Serology 04

VIROLOGY 04

BACTERIOLOGY 07

FUNGI 09

PARASITES 09

HORMONES-AUTOIMMUNITY 10

ADDITIONAL PRODUCTS 11

IgA Sets for Serology Diagnostics 11

Standards and Controls for CSF Diagnostics 11

Additional Components 11

Stool Antigen Detection 12

COMPLETE KITS 12

EXTERNAL CONTROLS 12

Line Immunoblot 13

VIROLOGY 14

BACTERIOLOGY 14

Rapid Test 16

VIROLOGY 16

Molecular Diagnosticsdiagnostics 17

NUCLEID ACID EXTRACTION 18

REAL TIME RT-PCR 18

Instrumentsiagnostics 19

THUNDERBOLT® 19

THE BOLT TM
20

AIX1000® 21

DYNABLOT 22

ARIA 23

GSD AUTO-PURE 96 24
About Us

The Gold Standard Diagnostics Group is a leading healthcare provider of diagnostic solutions composed by

three companies with extensive experience in the clinical market: Gold Standard Diagnostics Inc., Novatec

Immundiagnostica GmbH, and Virotech Diagnostics GmbH. The European branch, located in Dietzenbach

(Germany), concentrates the business of the Group outside the United States of America.

Gold Standard Diagnostics Europe provides Novatec Immundiagnostica and Virotech

automated platforms and a broad menu Diagnostics are ISO 13485:2016 certified, and most

of diagnostic tests in the fields of virology, of the products in this catalogue are CE marked,

bacteriology, parasitology, mycology, tumor fulfilling the European Directive 98/79/CE on in vitro

markers, hormones, and autoimmune diseases. diagnostic medical devices.

The company is engaged in innovative Additionally, we participate in several External

development, quality manufacturing, and Quality Assessment Control Programs such as:

outstanding commercialization of diagnostic INSTAND

solutions. Our aim is to be at the forefront UK NEQAS

of what the laboratories need, and we are ESfEQA

committed to delivering best-in-class assays RfB

and services to our vast network worldwide. Labquality

We will continue to devote all our efforts to College of American Pathologists

improving patient care.

ABOUT US 2
ELISA Kits
Serology

Wide range of Enzyme-linked Immunosorbent Assays for detecting antibodies against infectious diseases.
The ELISA product offering includes complete kits, IgA sets to complement IgG/IgM diagnostics, and
standards and controls for CSF Diagnostics. Multiple order numbers per product separated by a slash
correspond to the different Novatec and Virotech format respectively.

Ready-to-use, color-coded reagents, and breakable strip plates

Standardized methods suitable for automated procedures
Avidity and μ-capture tests available for some parameters
Special IgM-buffer to avoid interferences with rheumatoid factor
Validated for cerebrospinal fluid testing where diagnostically relevant
CE marked

VIROLOGY • Complete kits

Order No. Product description Format

ADVA0010 Adenovirus IgA 96 tests

Highly purified native antigen.
ADVG0010 Adenovirus IgG 96 tests
Highly purified native antigen.
EC121.00 Adenovirus IgG/IgM 96 tests
Additional IgA set available with order number EC121.08.
ADVM0010 Adenovirus IgM 96 tests
Highly purified native antigen.
CHIG0590 Chikungunya Virus IgG Capture 96 tests
Capture-technology for IgG to increase specificity.
CHIM0590 Chikungunya Virus IgM μ-Capture 96 tests
Capture-technology for IgM to increase specificity.
CMVG0110 Cytomegalovirus IgG 96 tests
ACMV7110 Cytomegalovirus IgG Avidity 48 tests
Can be used to determine the time of infection.
EC113.00 Cytomegalovirus IgG/IgM 96 tests
Mix of native and purified antigens. Validated for cerebrospinal fluid testing.
CMVM0110 Cytomegalovirus IgM 96 tests
DENG0120 Dengue Virus IgG 96 tests
It allows detection of antibodies against all 4 DENV types.
DENM0120 Dengue Virus IgM 96 tests
It allows detection of antibodies against all 4 DENV types.
DVM0640 Dengue Virus IgM μ-Capture 96 tests
Capture-technology to increase specificity.
96 tests
NS1D4020 Dengue Virus NS1 Antigen 96 tests
Detects of acute infections. 96 tests
EC116A00 Enterovirus IgA 96 tests
Screening assay for the detection of heterotypic IgA antibodies with 96 tests
coxsackievirus B5 and echovirus 24 antigens.
EC116G00 Enterovirus IgG 96 tests
Screening assay for the detection of heterotypic IgG antibodies with
coxsackievirus B5 and echovirus 24 antigens.
EC116M00 Enterovirus IgM 96 tests
Screening assay for the detection of heterotypic IgM antibodies with
coxsackievirus B5 and echovirus 24 antigens.

ELISA KITS 4
Order No. Product description Format

EBVG0080/ Epstein-Barr Virus EA-D IgG 96 tests

EC202.00
EBVG0580/ Epstein-Barr Virus EBNA IgG 96 tests
EC204.00 EC204.00 provides a special formula that allows a distinction between
primary and past infection in unclear cases.
EC102.00 Epstein-Barr Virus IgG/IgM 96 tests
Validated for cerebrospinal fluid testing.

EBVA0150 Epstein-Barr Virus VCA IgA 96 tests

EBVG0150/ Epstein-Barr Virus VCA IgG 96 tests
EC205G00 EC205G00 includes gp125 and p18 as highly specific markers.
AEBV7150 Epstein-Barr Virus VCA IgG Avidity 48 tests
Can be used to distinguish between acute and past infection.
EBVM0150/ Epstein-Barr Virus VCA IgM 96 tests
EC203M00 EC203M00 provides a special formula that allows a distinction between
primary and past infection in unclear cases.
HANG0670 Hantavirus IgG 96 tests
Recombinant antigen, contains four species/serotypes to detect it worldwide.
HANM0670 Hantavirus IgM 96 tests
Recombinant antigen, contains four species/serotypes to detect it worldwide.
HEVG0780 Hepatitis E Virus IgG 96 tests
Recombinant antigen for high sensitivity and specificity.
HEVM0780 Hepatitis E Virus IgM 96 tests
Recombinant antigen for high sensitivity and specificity.
EC130.00 Herpes Simplex Virus 1 (gG1) IgG/IgM 96 tests
Highly-specific recombinant glycoprotein gG1 antigen, validated for
cerebrospinal fluid testing.
HSV1G0500 Herpes Simplex Virus 1 IgG 96 tests
Highly-specific recombinant glycoprotein gG1 antigen.
HSV1M0500 Herpes Simplex Virus 1 IgM 96 tests
Highly-specific recombinant glycoprotein gG1 antigen.
HSVG0250 Herpes Simplex Virus 1+2 IgG 96 tests
HSVM0250 Herpes Simplex Virus 1+2 IgM 96 tests
EC131.00 Herpes Simplex Virus 2 (gG2) IgG/IgM 96 tests
Highly-specific affinity-purified glycoprotein gG2 antigen, validated for
cerebrospinal fluid testing.
HSV2G0540 Herpes Simplex Virus 2 IgG 96 tests
Highly-specific recombinant glycoprotein gG2 antigen.
HSV2M0540 Herpes Simplex Virus 2 IgM 96 tests
Highly-specific recombinant glycoprotein gG2 antigen.
EC108.00 Herpes Simplex Virus Screen IgG/IgM 96 tests
Validated for cerebrospinal fluid testing.

INFA0290/ Influenza Virus A IgA 96 tests

EC118A00 EC118A00 with seasonal updated antigens.
INFG0290 Influenza Virus A IgG 96 tests
EC118.00 Influenza Virus A IgG/IgM 96 tests
Seasonal updated antigens.
INFM0290 Influenza Virus A IgM 96 tests
INFA0300/ Influenza Virus B IgA 96 tests
EC119A00 EC119A00 with seasonal updated antigens.

INFG0300 Influenza Virus B IgG 96 tests

EC119.00 Influenza Virus B IgG/IgM 96 tests
Seasonal updated antigens.

INFM0300 Influenza Virus B IgM 96 tests

ELISA KITS 5
INFA0300/ Influenza Virus B IgA 96 tests
EC119A00 EC119A00 with seasonal updated antigens.
INFG0300 Influenza Virus B IgG 96 tests
EC119.00 Influenza Virus B IgG/IgM 96 tests
Seasonal updated antigens.
Order No. Product description Format

MEAG0330/ Measles Virus IgG 96 tests

EC105G00 Detects present and past contact with measles due to wild-virus or vaccination.
EC105G00 is adjusted to the WHO standards and is validated for cerebrospinal
fluid testing.
AMEA7330 Measles Virus IgG Avidity 48 tests
Can be used to differentiate between acute and past infection.
MEAM0330/ Measles Virus IgM 96 tests
EC105M00 MEAM0330 detects present and past contact with measles due to wild-virus
or vaccination.

MUMG0340 Mumps Virus IgG 96 tests

Detects present and past contact with mumps due to wild-virus or vaccination.
EC106.00 Mumps Virus IgG/IgM 96 tests
Detects acute infections in IgM, the serostatus in IgG, and is validated for
cerebrospinal fluid testing.
MUMM0340 Mumps Virus IgM 96 tests
Detects present and past contact with mumps due to wild-virus.

PAIA0360 Parainfluenza Virus 1, 2, 3 IgA 96 tests

PAIG0360 Parainfluenza Virus 1, 2, 3 IgG 96 tests
EC148.00 ParaScreen Virus IgG/IgM 96 tests
Additional IgA set available with order number EC148.08.

PARG0370 Parvovirus B19 IgG 96 tests

Recombinant antigen.
PARM0370 Parvovirus B19 IgM 96 tests
Recombinant antigen.

RSVA0380 Respiratory Syncytial Virus IgA 96 tests

RSVG0380 Respiratory Syncytial Virus IgG 96 tests
EC107.00 Respiratory Syncytial Virus IgG/IgM 96 tests
Additional IgA set available with order number EC107.08.
RSVM0380 Respiratory Syncytial Virus IgM 96 tests
EC109L00 Rubella Virus CSF IgG 96 tests
For cerebrospinal fluid testing only, additional available standards
and control sets.
RUBG0400 Rubella Virus IgG 96 tests
ARUB7400 Rubella Virus IgG Avidity 48 tests
Can be used to differentiate between acute and past infection.
RUBM0400 Rubella Virus IgM μ-Capture 96 tests
Capture technology to increase specificity.

EC123A00 SARS-CoV-2 (COVID-19) Virus IgA 96 tests

EC123G00 SARS-CoV-2 (COVID-19) Virus IgG 96 tests
Offered with high and low prevalence cut-off adjustment.
EC123M00 SARS-CoV-2 (COVID-19) Virus IgM 96 tests
CVGQ0970 SARS-CoV-2 (COVID-19) quantitative IgG 96 tests
Quantitative determination of antibodies to the spike (S) protein. Calibrators
correlate to the “First WHO International Standard for anti SARS-CoV-2
immunoglobulin (human)”.
TICG0440 Tick-Borne Encephalitis IgG 96 tests
Quantitative assay with antibody titer profile to verify immune status.
PTICG044 Tick-Borne Encephalitis IgG plus 96 tests
Quantitative assay with antibody titer profile to verify immune status.
It contains an additional control.
EC117.00 Tick-Borne Encephalitis IgG/IgM 96 tests
Detects acute/recent infection and vaccination antibodies. Validated for
cerebrospinal fluid testing.
TICM0440 Tick-Borne Encephalitis IgM 96 tests
Can be used to verify immune status.

ELISA KITS 6
 Order No. Product description Format

VZVA0490 Varicella-Zoster Virus IgA 96 tests

VZVG0490 Varicella-Zoster Virus IgG 96 tests
Can be used for measuring antibody response after varicella vaccination.
EC110.00 Varicella-Zoster Virus IgG/IgM 96 tests
IgG cut-off adjusted to follow Robert Koch Institute recommendations of
seropositivity; IgG is aligned to the WHO standards. Additional IgA set available
with order number EC110.08. Validated for cerebrospinal fluid testing.
VZVM0490 Varicella-Zoster Virus IgM 96 tests
ZVG0790 Zika Virus IgG Capture 96 tests
Recombinant NS1 antigen. Capture-technology increases specificity and
reduces cross reactivity.
ZVM0790 Zika Virus IgM μ-Capture 96 tests
Recombinant NS1 antigen. Capture-technology increases specificity and
reduces cross reactivity.

BACTERIOLOGY • Complete kits

Order No. Product description Format

BAR0900 Bartonella 96 tests

Total antibody assay coated with highly purified native antigen.
EC115.00 Bordetella pertussis (FHA+PT) IgG/IgA 96 tests
Sensitive screening assay coated with PT and FHA antigens.
BOPA0030 Bordetella pertussis IgA 96 tests
Sensitive screening assay coated with PT and FHA antigens.
BOPG0030 Bordetella pertussis IgG 96 tests
Sensitive screening assay coated with PT and FHA antigens.
BOPM0030 Bordetella pertussis IgM 96 tests
BPTA0610/ Bordetella pertussis toxin IgA 96 tests
EC215A00 Pure PT antigens, adjusted to the WHO standards.
BPTG0610/ Bordetella pertussis toxin IgG 96 tests
EC215G00 Pure PT antigens, adjusted to the WHO standards. EC215G00 available with
additional IgG quantification set.

EC215M00 Bordetella pertussis toxin IgM 96 tests

Pure PT antigens.

EC022G00 Borrelia + VlsE IgG 96 tests

Antigen mix of B. afzelii PKo, B. garinii strain PBr, and B. burgdorferi strain ZS7
for high sensitivity and specificity. Validated for cerebrospinal fluid testing.
EC024G00 Borrelia + VlsE IgG Europe 96 tests
Validated for cerebrospinal fluid testing.
EC022M00 Borrelia IgM 96 tests
Borrelia strain Pko for high sensitivity. Validated for cerebrospinal fluid testing.
BORG0040 Borrelia burgdorferi IgG 96 tests
Recombinant antigen, validated for serum, plasma, and cerebrospinal fluid
testing.
BORM0040 Borrelia burgdorferi IgM 96 tests
Recombinant antigen, validated for serum, plasma, and cerebrospinal fluid
testing.
BRUG0050 Brucella IgG 96 tests
EC101.00 Brucella IgG/IgM 96 tests
Additional IgA set available with order number EC101.08.

BRUM0050 Brucella IgM 96 tests

ELISA KITS 7
BRUG0050 Brucella IgG 96 tests
EC101.00 Brucella IgG/IgM 96 tests
Additional IgA set available with order number EC101.08.
Order No. Product description Format

CHLA0510 Chlamydia pneumoniae IgA 96 tests

CHLG0510 Chlamydia pneumoniae IgG 96 tests
CHLM0510 Chlamydia pneumoniae IgM 96 tests
CHLA0070 Chlamydia trachomatis IgA 96 tests
CHLG0070 Chlamydia trachomatis IgG 96 tests
CHLM0070 Chlamydia trachomatis IgM 96 tests
CORG5009 Diphtheria toxin 5S IgG 96 tests
Quantitative assay with 5 standards for verification of immune status due to
vaccination or contact with Corynebacterium diphtheriae.
PCORG009 Diphtheria toxin 5S IgG plus 96 tests
Quantitative assay with 5 standards and one additional control for verification
of immune status due to vaccination or contact with Corynebacterium
diphtheriae.
CORG0090/ Diphtheria toxin IgG 96 tests
EC129.00 Quantitative assay. CORG0090 allows verification of immune status due to
vaccination or contact with Corynebacterium diphtheriae. EC129.00 is adjusted to
the WHO standards.
EC143A00 Helicobacter pylori IgA 96 tests
HELG0220/ Helicobacter pylori IgG 96 tests
EC143G00 HELG0220 is a quantitative assay with recombinant antigen.

PHELG022 Helicobacter pylori IgG plus 96 tests

Quantitative assay with recombinant antigen plus one control.
HELM0220 Helicobacter pylori IgM 96 tests
LEGG0650 Legionella pneumophila IgG 96 tests
Assay with antigens from a pool of different serovars to increase sensitivity.
LEGM0650 Legionella pneumophila IgM 96 tests
Assay with antigens from a pool of different serovars to increase sensitivity.

LEPM0660 Leptospira IgM 96 tests

LEPG0660 Leptospira IgG 96 tests
MYCA0350 Mycoplasma pneumoniae IgA 96 tests
Highly purified antigens.
MYCG0350 Mycoplasma pneumoniae IgG 96 tests
Highly purified antigens.
EC114.00 Mycoplasma pneumoniae IgG/IgM 96 tests
Detects acute infections in IgG and offers specific cut-off adjustment
for infant samples. Additional IgA set available with order number EC114.08.
MYCM0350 Mycoplasma pneumoniae IgM 96 tests
Highly purified antigens.

TETG5043 Tetanus toxin 5S IgG 96 tests

Quantitative assay adjusted to the WHO standards with recombinant antigen
and 5 standards.
PTETG043 Tetanus toxin 5S IgG plus 96 tests
Quantitative assay adjusted to the WHO standards with recombinant antigen
and 5 standards plus one control.
TETG0430 Tetanus toxin IgG 96 tests
Quantitative assay adjusted to the WHO standards wih recombinant antigen.

EC124.00 Tetanus toxoid IgG 96 tests

Quantitative assay adjusted to the WHO standards.
EC142.00 Yersinia enterocolitica IgG/IgA 96 tests
Mix of purified native antigens and recombinant antigens YopD, YopB and YopE.
YERG0990 Yersinia enterocolitica IgG 96 tests
YERA0990 Yersinia enterocolitica IgA 96 tests

ELISA KITS 8
FUNGI • Complete kits
Order No. Product description Format

ASPG0680 Aspergillus fumigatus IgG 96 tests

ASPM0680 Aspergillus fumigatus IgM 96 tests
CANA0060 Candida albicans IgA 96 tests
CANG0060 Candida albicans IgG 96 tests
EC111.00 Candida albicans IgG/IgM 96 tests
Designed to detect acute infections, offers an additional IgA set with
order number EC111.08.
CANM0060 Candida albicans IgM 96 tests

PARASITES • Complete kits

Order No. Product description Format

ASCG0020 Ascaris lumbricoides IgG 96 tests

Native antigen for high sensitivity.
CHAG0560 Chagas IgG 96 tests
Chimeric-recombinant antigens to reduce cross-reactivity to Leishmania and
Malaria.
ECHG0130 Echinococcus IgG 96 tests
ENTG0140 Entamoeba histolytica IgG 96 tests
FIL0760 Filariasis 96 tests
Detects antibodies against main genus of filarial worms
(Onchocerca, Loa loa, and Wuchereria).
LEIG0310 Leishmania infantum IgG 96 tests
Specific antigens to reduce cross reactivity to Chagas.
MAL0620 Malaria 96 tests
Recombinant antigens to reduce cross reactivity to other parasites.
SCHG0410 Schistosoma mansoni IgG 96 tests
SCHM0410 Schistosoma mansoni IgM 96 tests
STRO0690 Strongyloides 96 tests
Chimeric-recombinant antigen to increase specificity. Detects the main human
pathogen species.

TAEG0420 Taenia solium IgG 96 tests

Native antigen for high sensitivity.
TOCG0450 Toxocara canis IgG 96 tests
TOXA0460 Toxoplasma gondii IgA 96 tests
TOXG0460 Toxoplasma gondii IgG 96 tests
Quantitative assay. Calibrated against WHO standard.
ATOX7460 Toxoplasma gondii IgG Avidity 48 tests
TOXM0460 Toxoplasma gondii IgM μ-Capture
Capture assay to reduce cross-reactivity. 96 tests
TRIG0480 Trichinella spiralis IgG 96 tests

ELISA KITS 9
HORMONES-AUTOIMMUNITY • Complete kits
Order No. Product description Format

DNOV003 17 beta-Estradiol 96 tests

DNOV004 17-OH Progesterone 96 tests

DNOV033 AFP 96 tests

DNOV012 Aldosterone 96 tests
DNOV008 Androstenedione 96 tests
DSNOV27 Androstenedione Saliva 96 tests
ATG1010 Anti-TG (Recombinant antigen) 96 tests
ATPO1020 Anti-TPO 96 tests
DNOV034 beta-HCG 96 tests
DNOV061 CA 125 96 tests
DNOV062 CA 15-3 96 tests
DNOV063 CA 19-9 96 tests
DNOV060 CEA 96 tests
DNOV096 CH-50 96 tests
DNOV093 CIC C1q 96 tests
DNOV094 CIC C3d 96 tests

DNOV001 Cortisol 96 tests

DSNOV20 Cortisol Saliva 96 tests

DNOV112 C-Peptide 96 tests

DNOV005 DHEA-S 96 tests
DSNOV24 DHEA-S Saliva 96 tests
DNOV100 Ferritin 96 tests
DNOV051 Free T3 96 tests
FT41050 Free T4 96 tests
DNOV009 Free Testosterone 96 tests
DNOV031 FSH 96 tests
DNOV101 HGH 96 tests
DNOV102 IgE 96 tests
DNOV111 Insulin 96 tests
DNOV030 LH 96 tests
DNOV006 Progesterone 96 tests
DNOV032 Prolactin 96 tests
RFM3010 Rheumatoid Factor IgM (Fc fragments of human IgG for high specificity) 96 tests

DNOV002 Testosterone 96 tests

DSNOV21 Testosterone Saliva 96 tests

DNOV057 Thyroglobulin 96 tests

DNOV064 Total PSA 96 tests
DNOV053 Total T3 96 tests
DNOV054 Total T4 96 tests
TSH1030
DSNOV21 TSH (Quantitative
Testosterone Saliva
assay adjusted to the WHO standard) 96 tests
96 tests
DNOV010 Urinary Cortisol 96 tests

ELISA KITS 10
ELISA • Additional products

IgA Sets for Serology Diagnostics

Order No. Product description Related Kit Order No. Format

Corresponding kit No.
EC121.08 Adenovirus IgA Set EC121.00 3 x 1.3 ml & 1 x 11 ml
EN215Q60 Bordetella pertussis IgG quantification EC215G00 3 x 2 ml
EC101.08 Brucella IgA Set EC101.00 3 x 1.3 ml & 1 x 11 ml
EC111.08 Candida albicans IgA Set EC111.00 3 x 1.3 ml & 1 x 11 ml
EC114.08 Mycoplasma pneumoniae IgA Set EC114.00 3 x 1.3 ml & 1 x 11 ml
EC148.08 ParaScreen Virus IgA Set EC148.00 3 x 1.3 ml & 1 x 11 ml
EC107.08 Respiratory Syncytial Virus IgA Set EC107.00 3 x 1.3 ml & 1 x 11 ml
EC110.08 Varicella-Zoster Virus IgA Set EC110.00 3 x 1.3 ml & 1 x 11 ml

Standards and Controls for CSF Diagnostics

Order No. Product description Related Kit Order No. Format

EN022L65 Borrelia + VlsE IgG CSF AI Control Set EC022G00/EC024G00 4 x 1 ml

EC022L60 Borrelia + VlsE IgG CSF Standards EC022G00/EC024G00 4 x 1 ml
EC022L80 Borrelia afzelii IgM CSF Standards EC022M00 4 x 1 ml
EC113L60 Cytomegalovirus IgG CSF Standards EC113.00 4 x 1 ml
EN102L65 Epstein-Barr Virus IgG CSF AI Control Set EC102.00 4 x 1 ml
EC102L60 Epstein-Barr Virus IgG CSF Standards EC102.00 4 x 1 ml
EC130L60 Herpes Simplex Virus 1 (gG1) IgG CSF Standards EC130.00 4 x 1 ml
EC131L60 Herpes Simplex Virus 2 (gG2) IgG CSF Standards EC131.00 4 x 1 ml
EN108L65 Herpes Simplex Virus Screen IgG CSF AI Control Set EC108.00 4 x 1 ml
EC108L60 Herpes Simplex Virus Screen IgG CSF Standards EC108.00 4 x 1 ml

EN105L65 Measles Virus IgG CSF AI Control Set EC105.00 4 x 1 ml

EC105L60 Measles Virus IgG CSF Standards EC105.00 4 x 1 ml

EC106L60 Mumps Virus IgG CSF Standards EC106.00 4 x 1 ml

EN109L65 Rubella Virus IgG CSF AI Control Set EC109L00 4 x 1 ml
EC109L60 Rubella Virus IgG CSF Standards EC109L00 4 x 1 ml

EN117L65 Tick-Borne Encephalitis IgG CSF AI Control Set EC117.00 4 x 1 ml

EC117L60 Tick-Borne Encephalitis IgG CSF Standards EC117.00 4 x 1 ml
EC117L80 Tick-Borne Encephalitis IgM CSF Standards EC117.00 4 x 1 ml

EC110L40 Varicella-Zoster Virus IgA CSF Standards EC117.00 4 x 1 ml

EN110L65 Varicella-Zoster Virus IgG CSF AI Control Set EC110.00 4 x 1 ml
EC110L60 Varicella-Zoster Virus IgG CSF Standards EC110.00 4 x 1 ml

EC110.00
Additional Components Corresponding kit No.

Order No. Product description Format

EN250K60 Pipetting Control Set (For use with EC250.00.) 2.8 ml & 2 x 50 ml PBS buffer
161102 RF-SorboTech 10 ml
161101 Pre-adsorbance for all IgM ELISA assays starting with 2 ml
”EC” as well as EC215A00.
B/300.00 2 vials RF - 2 ml & buffer
EC250.00 Validation Kit 96 tests

ELISA KITS 11
Stool Antigen Detection
Gold Standard Diagnostics Europe distributes the stool testing products from Seramun Diagnostica GmbH.
The Serazym® product range comprises ELISA tests and controls for the detection of different viral, bacterial,
and parasitological antigens in faecal specimens. The external quality controls are offered twice a year; please
contact us for further information.

COMPLETE KITS
Order No. Product description Format

HW/E-017 Serazym® Adenovirus 96 tests

HW/E-017-A2 2 x 96 tests
HW/E-045 Serazym® Astrovirus 96 tests
HW/E-045-A2 2 x 96 tests

HW/E-093 Serazym® Campylobacter 96 tests

HW/E-093-A2 2 x 96 tests

HW/E-107 Serazym® Clostridium difficile GDH 96 tests

HW/E-107-A2 2 x 96 tests
HW/E-040 Serazym® Clostridium difficile Toxin A+B 96 tests
HW/E-040-A2 2 x 96 tests
HW/E-039-A Serazym® Cryptosporidium parvum 96 tests
HW/E-018-A Serazym® Entamoeba histolytica 96 tests
HW/E-106-A Serazym® Giardia 96 tests
HW/E-114-A Serazym® Helicobacter pylori 2nd Generation 96 tests
HW/E-061 Serazym® Norovirus 96 tests
HW/E-061-A2 2 x 96 tests
HW/E-020 Serazym® Rotavirus 96 tests
HW/E-020-A2 2 x 96 tests
HW/E-030 Serazym® Verotoxin 1+2 96 tests
HW/E-030-A2 2 x 96 tests

EXTERNAL CONTROLS
Order No. Product description Format

HW/EK-017 Adenovirus 2 x 0.4 ml

HW/EK-045 Astrovirus 2 x 0.4 ml
HW/EK-093 Campylobacter 2 x 0.4 ml
HW/EK-107 Clostridium difficile GDH 2 x 0.4 ml
HW/EK-040 Clostridium difficile Toxin A&B 2 x 0.4 ml
HW/EK-039 Cryptosporidium parvum 2 x 0.4 ml
HW/EK-018 Entamoeba histolytica 2 x 0.4 ml
HW/EK-106 Giardia 2 x 0.4 ml
HW/EK-114 Helicobacter pylori 2 nd Generation 2 x 0.4 ml
HW/EK-061 Norovirus 2 x 0.4 ml
HW/EK-020 Rotavirus 2 x 0.4 ml
HW/EK-030 Verotoxin 1+2 2 x 0.4 ml

ELISA KITS 12
ELISA KITS 15
 Line Immunoblot
Wide range of Line Immunoassays for the qualitative detection of pathogen-specific IgG, IgM, and IgA antibodies
in human serum.

Firm strips sorted in a booklet

Positive and negative controls separately available
Standardized methods suitable for automated procedures
Interpretation software available
CE marked

VIROLOGY
Order No. Product description Format

WE102G32 Epstein-Barr Virus IgG 32 tests

Differentiates between primary and past infection and offers a special cut-off Format
WE102G96 strategy for the EBNA1 interpretation. 96 tests

WE102M32 Epstein-Barr Virus IgM 32 tests

Differentiates between primary and past infection and offers a special cut-off
WE102M96 strategy for the EBNA1 interpretation. 96 tests

WE130G16 Herpes Simplex Virus IgG 16 tests

Use of gG1-recombinant and gG2-purified as well as a native total antigen to
WE130G32 differentiate between HSV 1 and 2. 32 tests

BACTERIOLOGY
Order No. Product description Format

WE116A32 Bordetella pertussis + CatACT IgA 32 tests

Differentiates between vaccination and infection, and gives notice of
WE116A96 a parapertussis infection. 96 tests

WE116G32 Bordetella pertussis + CatACT IgG 32 tests

Differentiates between vaccination and infection, and gives notice of
WE116G96 a parapertussis infection. 96 tests

WE225G32 Borrelia Europe + TpN17 IgG 32 tests

Includes the Treponema-band TpN17 as exclusion marker, validated for
WE225G96 cerebrospinal fluid testing. 96 tests

WE224G32 Borrelia Europe IgG 32 tests

Combination of purified lysate antigens (OspC, DbpA-PKo) and recombinant
WE224G96 antigens (VlsE, p83, p58, p39, DbpA-mix), validated for cerebrospinal fluid testing. 96 tests

WE224M32 Borrelia Europe IgM 32 tests

Combination of purified lysate antigens (OspC) and recombinant antigens (VlsE,
WE224M96 p39, DbpA-mix), provides an additional EBV band as exclusion marker, validated 96 tests
for cerebrospinal fluid testing.

LINE IMMUNOBLOT 14
Order No. Product description Format

WE223G32 Borrelia in vivo + TpN17 IgG 32 tests

Includes the Treponema-band TpN17 as exclusion marker, validated for
WE223G96 96 tests
cerebrospinal fluid testing.

WE222G32 Borrelia in vivo IgG 32 tests

Combination of the most important common antigens (VlsE, p39, p83/100) with
WE222G96 well-known ”in-vivo“ antigens. Validated for cerebrospinal fluid testing. 96 tests

WE222M32 Borrelia in vivo IgM 32 tests

Combination of the most important common antigens (OspC, VlsE, p39) and
WE222M96 96 tests
EBV-band as exclusion marker. Validated for cerebrospinal fluid testing.
WE243A32 Helicobacter pylori IgA 32 tests
Therapy-relevant differentiation of virulent and non-virulent strains with CagA
WE243A96 and VacA. 96 tests

WE243G32 Helicobacter pylori IgG 32 tests

Therapy-relevant differentiation of virulent and non-virulent strains with CagA
WE243G96 and VacA. 96 tests

WE214A16 Mycoplasma pneumoniae IgA 16 tests

Detection of acute or recent infection.

WE214G16 Mycoplasma pneumoniae IgG 16 tests

Detection of acute or recent infection.

WE214M16 Mycoplasma pneumoniae IgM 16 tests

Detection of acute or recent infection.

WE150G16 Syphilis IgG 16 tests

WE150G32 Uses recombinant proteins. 32 tests
WE150M16 Syphilis IgM 16 tests
WE150M32 Uses recombinant proteins. 32 tests
WE242A32 Yersinia enterocolitica IgA 32 tests
Detection of reactive bands contributes towards the diagnosis of Yersinia-
WE242A96 associated sequelae, as reactive arthritis. 96 tests
WE242A32 Yersinia enterocolitica IgA 32 tests
WE242G32 Yersinia enterocolitica
Detection IgG contributes towards the diagnosis of
of reactive bands 32 tests
WE242A96 Yersinia-associated sequelae,
Detection of reactive bands as reactive
contributes arthritis.
towards the diagnosis of Yersinia- 96 tests
WE242G96 associated sequelae, as reactive arthritis. 96 tests
WE242G32 Yersinia enterocolitica IgG 32 tests
Detection of reactive bands contributes towards the diagnosis of

LINE IMMUNOBLOT 15
 Rapid Tests
Rapid chromatographic immunoassays for the qualitative detection of SARS-CoV-2 Nucleocapsid (N) Protein
antigens present in respiratory samples.

Easy specimen collection

High sensitivity and specificity
Fast results in 15 minutes
Intuitive visual interpretation
CE marked

VIROLOGY
Order No. Product description Format

CVAG4080A GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP swab) 20 tests

CVAG4080B GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal swab) 20 tests
CVAG502H05 GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal swab) for self testing 5 tests

RAPID TESTS 16
LINE IMMUNOBLOT 19
Molecular Diagnostics
NUCLEID ACID EXTRACTION

Assays for the isolation of high-quality RNA from human respiratory specimen types.

Automated, magnetic bead extraction method

Efficient and reliable process which ensures the removal of potential inhibitors from sample matrices
Perfect complement for virus detection assays

Order No. Product description Format

5524401101 GSD NovaPrime® IVD RNA Extraction AE1 1 x 96 reactions

5524401201 20 x 96 reactions
55244011100 100 x 96 reactions

5524411020 GSD NovaPrime® IVD RNA Extraction AE1 RTU 20 x 96 reactions

5524411100 100 x 96 reactions

5524401301 GSD NovaPrime® IVD RNA Extraction AE2 1 x 96 reactions

5524401401 20 x 96 reactions

REAL TIME RT-PCR

High quality RT-PCR kits for detection of various infectious diseases.

Fast and reliable results in approximately 1 hour

Validated for a variety of specimen types
Excellent performance with high sensitivity and specificity
Extraction/inhibition and positive control included
Suitable for most PCR platforms

Order No. Product description Format

PCOV6111 GSD NovaPrime® TSP SARS-CoV-2 1 x 96 reactions

Contains specific primers and probes for amplification and
PCOV6113 simultaneous detection of RNA sequences, and a heterologous 3 x 96 reactions
amplification target to identify possible RT-PCR inhibition.

PCOV6181 GSD NovaType Detect + Select K417N SARS-CoV-2 (RUO) 1 x 96 reactions

Identification of N gene (N1/N2) and K417N mutation in one reaction.
PCOV6184 4 x 96 reactions

PRES6131 Mplex SARS-CoV-2+, Flu A, Flu B (C1) 1 x 96 reactions

Differentiates in a single reaction between Influenza A and B, and
PRES6134 simultaneously detects two independent gene targets in SARS-CoV-2 4 x 96 reactions
(N-gene + RdRP-gene).

PRSV6161 RSV A, RSV B 1 x 96 reactions

Differentiates in a single reaction between RSV A and RSV B.
PRSV6164 4 x 96 reactions

MOLECULAR DIAGNOSTICS 18
Instruments

ThunderBolt®

Order No. Product description

00300-CL ThunderBolt® EIA/CLIA Analyzer

00300 ThunderBolt® EIA Analyzer

Main features

2-plate, fully automated, open platform, that can run ELISA and Chemiluminescence (CLIA) assays.

Slide-in racks with positive sample identification

Simple workflow software that guides you through the process
Designed to suit different laboratory demands
High sample loading capacity: 192 primary sample tubes
Capable of running many different protocols in a single batch
On-board camera allows remote troubleshooting
No disposable tips, minimal consumables, direct in-well dilution (up to 1:100)
Occupies minimal bench space

INSTRUMENTS 19
The BoltTM

Order No. Product description

EIA/CLIA-00500-CL The BoltTM EIA/CLIA Analyzer

EIA- 00500 The BoltTM EIA Analyzer

Main features

1-plate, fully automated, open platform, that can run ELISA and Chemiluminescence (CLIA) assays.

Slide-in racks with positive sample identification

Simple workflow software that guides you through the process
Designed to suit different laboratory demands
High sample loading capacity: 96 primary sample tubes
Capable of running many different protocols in a single batch
No disposable tips, minimal consumables, direct in-well dilution (up to 1:100)
Occupies 60 cm lab bench

INSTRUMENTS 20
AIX1000®

Order No. Product description

00400 AIX1000®

Main features

The AIX1000® is an FDA cleared, CE marked, fully automated system for nontreponemal, rapid
plasma reagin (RPR) testing designed to simplify the processing, analysis, and results interpretation
for RPR screens and titers. With the new universal slide-in rack system accommodating a variety of
tube sizes, sample loading has become even easier and faster.

■ Runs screens and titers – up to 192 samples in 90 minutes

■ Full sample traceability: integrated barcode reading compatible with 1D and 2D barcodes
■ Proprietary image recognition algorithm gives objective results
■ Reduced labor overhead: reduced TAT and hands on
■ Easy access to test results: save data and review on demand
■ Improved Database Management cutting in half the time to perform backups/restore
■ Remote data archiving capabilities and an expandable status log
■ For use with AIX1000® RPR Reagent kit (order no. # GSD01-1600) and AIX1000® RPR Reagent
bulk kit (order no. # GSD34-1600-R)

INSTRUMENTS 21
Dynablot

Order No. Product description

T/D2144-CZ-DRY Dynablot Automatic

T/D2144-CZC-DRY Dynablot Automatic with camera

Main features

Fully automated instrument for Line Immunoblot testing.

Automatic sample pipetting from primary tubes

44 samples per run
Strip image capture by camera
Drying of strips
Walk-away operation
User friendly software for easy and comprehensible operation
Primary tubes bar code reader

INSTRUMENTS 22
Aria

AriaMxTM AriaDxTM

Order No. Product description

K893064001 AriaDxTM

G8830A AriaMxTM (RUO)

Main features

Modular and precise real time PCR instrument.

Standardized methods suitable for automated procedures

96 samples
Scan all channels in less than three seconds
Factory calibrated
Intuitive touch screen interface
Modular optical cartridges: 1-6 filter capability
On board self-diagnostics

INSTRUMENTS 23
GSD Auto-Pure 96

Order No. Product description

AS-17060-00 GSD Auto-Pure 96 - Nucleic Acid Purification System

Main features

Automatic extraction and purification system for DNA/RNA, proteins and cells.

■ Built-in lighting LED lights

■ 96 samples
■ Front cover can be opened for quick stop, convenient for reagent optimization
■ Intelligent operation with self-inspection, power protection function
■ 8-plate position automatic identification design.
■ No manual adjustment required
■ Disposable consumables can eliminate the cross contamination between holes and batches.
■ Built-in disinfection function
■ High quality and rapid extraction: It can process 96×1ml samples simultaneously
■ Maximum sample size: 10ml

INSTRUMENTS 24
Gold Standard Diagnostics Europe
+49 6074 23698-0 · info@goldstandarddiagnostics.eu · www.goldstandarddiagnostics.com
Not available in the U.S. with the exception of the AIX1000®, ThunderBolt, and Bolt®.
Contact your local representative for more details.
GSDB007.0522-EN