en

Toxo IgM
system
6C20
48-1856/R1
B6C200

Toxo IgM
Customer Service
For additional product information, please contact your local customer service organization.
This package insert must be read carefully prior to use. Package insert instructions must be followed. Reliability of assay
results cannot be guaranteed if there are any deviations from the instructions in this package insert.

Key to symbols used

List Number Calibrator 1
In Vitro Diagnostic Medical
Device Assay CD-ROM

Lot Number Control Number

Expiration Date Reagent Lot

Store at 2-8°C Reaction Vessels

Sample Cups
Caution, consult accompanying
documents Septum

Serial Number Replacement Caps

Negative Control
Manufacturer
Positive Control

See REAGENTS section for a full explanation of symbols used in reagent

component naming.

ABBOTT
Diagnostics Division

1
NAME BIOLOGICAL PRINCIPLES OF THE PROCEDURE
ARCHITECT Toxo IgM The ARCHITECT Toxo IgM assay is a two-step immunoassay for the
qualitative detection of IgM antibodies to Toxoplasma gondii in human
INTENDED USE serum and plasma using CMIA technology with flexible assay protocols,
The ARCHITECT Toxo IgM assay is a chemiluminescent microparticle referred to as Chemiflex.
immunoassay (CMIA) for the qualitative detection of IgM antibodies to
Toxoplasma gondii in human serum and plasma. In the first step, pre-diluted sample and anti-human IgM mouse monoclonal
antibody coated paramagnetic microparticles are combined. Together with
SUMMARY AND EXPLANATION OF TEST IgM antibodies of other specificities, anti-Toxo specific IgM present in the
Toxoplasma gondii is an obligate intracellular protozoan parasite that sample is bound by the anti-human IgM mouse monoclonal antibody coated
infects most species of warm-blooded animals, including humans1. microparticles, forming an antibody-antibody complex. After washing, a
Toxoplasmosis is primarily acquired by ingestion of undercooked, infected conjugate complex consisting of an acridinium-labeled anti-Toxo p30
meat; via oocysts from fecally contaminated hands, food and water; and antigen mouse monoclonal F(ab’)2 fragment and native Toxoplasma gondii
maternally through transplacental transmission2. In addition, transmission lysate, containing the p30 antigen, is added to create a reaction mixture in
associated with organ transplantation and during blood transfusion has the second step. This conjugate complex is bound by anti-Toxo specific
been reported, although the risk of transmission through blood transfusion IgM that has been captured by the anti-human IgM mouse monoclonal
is extremely low3. antibody coated microparticles in the first step, forming an antibody-
Acquired infection with Toxoplasma gondii in healthy individuals is antibody-conjugate complex. Following another wash cycle, pre-trigger
commonly asymptomatic, however 10-20% of patients with acute infection and trigger solutions are added to the reaction mixture.
may develop lymphadenopathy4. The resulting chemiluminescent reaction is measured as relative light units
Severe infections can occur in AIDS patients and adults (RLUs). A direct relationship exists between the amount of anti-Toxo IgM
immunocompromised by cancer chemotherapy or transplant recipients in the sample and the RLUs detected by the ARCHITECT i System optics.
receiving immunosuppressive treatment. These infections can be fatal. The presence or absence of anti-Toxo IgM in the sample is determined
Toxoplasmic encephalitis is the most common presentation and is the by comparing the chemiluminescent signal in the reaction to the cutoff
most frequent cause of focal central nervous system lesions in AIDS signal determined from an active calibration curve. If the chemiluminescent
patients5. signal in the specimen is greater than or equal to the cutoff signal, the
Primary infection during pregnancy can result in transplacental transmission sample is considered reactive for anti-Toxo IgM.
of the parasite resulting in congenital infection. The risk of congenital For additional information on system and assay technology refer to the
infection is lowest (10-25%) if acute maternal infection occurs during the ARCHITECT System Operations Manual, Section 3.
first trimester and highest (60-90%) if it occurs during the third trimester2. REAGENTS
Severity of congenital infection is greatest when maternal infection
Reagent Kit, 100 Tests/500 Tests
is acquired early during pregnancy. Common outcomes of congenital
NOTE: Some kit sizes are not available in all countries or for use on all
toxoplasmosis includes chorioretinitis, intracranial calcifications, and
ARCHITECT i Systems. Please contact you local distributor.
hydrocephalus. The majority of infants infected later in pregnancy are
asymptomatic at birth, with sequelae occurring later in life. ARCHITECT Toxo IgM Reagent Kit (6C20)
Early treatment after prenatal diagnosis of Toxoplasma gondii infection • 1 Bottle (6.6 mL per 100-test bottle/27.0 mL per
has been shown to reduce the frequency and severity of congenital 500-test bottle) anti-human IgM (mouse, monoclonal) antibody coated
toxoplasmosis6. Serological tests can be used to identify seronegative microparticles in TRIS buffer with protein stabilizers and detergent.
women, who then should be monitored during pregnancy. Minimum concentration: 0.08% solids. Preservatives: antimicrobial
agents.
The presence of IgG antibodies to Toxoplasma gondii indicates that
infection has occurred but does not distinguish between recent and past • 1 Bottle (5.9 mL per 100-test bottle/26.3 mL per
infection. IgM antibodies are detected in individuals with a recently acquired 500-test bottle) conjugate complex consisting of acridinium-labeled
infection, but antibodies may persist for up to 18 months post-infection2. anti-Toxoplasma p30 antigen (mouse, monoclonal) antibody and native
To differentiate between a recently acquired and a past infection, IgM Toxoplasma gondii lysate in phosphate buffer with protein stabilizers
and IgG positive specimens should be tested for IgG avidity. A high avidity and detergent. Minimum concentration: 25 μg/mL. Preservative:
index for IgG antibodies is a strong indication that an infection took place sodium azide.
more than 4 months ago. Low avidity results cannot be used to diagnose Other Reagents
an acute toxoplasmosis. ARCHITECT i Pre-Trigger Solution
Toxo IgG May indicate.../ Testing • Pre-Trigger Solution containing 1.32% (w/v)
Toxo IgG Toxo IgM Avidity recommendation hydrogen peroxide.
nonreactive nonreactive N/A no infection ARCHITECT i Trigger Solution
nonreactive reactive N/A obtain new sample • Trigger Solution containing 0.35 N sodium
2-3 weeks after initial hydroxide.
sample and test for ARCHITECT i Wash Buffer
Toxo IgG and Toxo IgM • Wash Buffer containing phosphate buffered saline
reactive nonreactive high avidity past infection. Strong solution. Preservatives: antimicrobial agents.
indication that an infection WARNINGS AND PRECAUTIONS
took place more than
•
4 months ago
reactive reactive low avidity obtain new sample Safety Precautions
3 weeks after initial
sample and test for
Toxo IgG and Toxo IgM • CAUTION: This product contains human-sourced infectious
and/or potentially infectious components. Refer to the REAGENTS
reactive reactive high avidity past infection. Strong section of this package insert. No known test method can offer
indication that an infection complete assurance that products derived from human sources or
took place more than inactivated microorganisms will not transmit infection. Therefore, it
4 months ago is recommended that all human-sourced materials be considered
potentially infectious and handled with appropriate biosafety
practices.

2
• For product not classified as dangerous per European Directive SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS
1999/45/EC as amended - Safety data sheet available for professional Specimen Types
user on request. The specimen collection tubes listed below were verified to be used with
• For information on the safe disposal of sodium azide and a detailed the ARCHITECT Toxo IgM assay.
discussion of safety precautions during system operation, refer to the • Human serum (including serum collected in serum separator tubes)
ARCHITECT System Operations Manual, Section 8.
• Human plasma collected in:
Handling Precautions • Plasma separator tubes (lithium heparin)
• Do not use reagent kits beyond the expiration date. • Potassium EDTA
• Do not pool reagents within a kit or between reagent kits. • Sodium heparin
• Before loading the ARCHITECT Toxo IgM Reagent Kit on the system • Lithium heparin
for the first time, the microparticle bottle requires mixing to resuspend • Liquid anticoagulants may have a dilution effect resulting in lower
microparticles that have settled during shipment. For microparticle concentrations for individual patient specimens.
mixing instructions, refer to the PROCEDURE, Assay Procedure
• Sodium citrate tubes cannot be used with the ARCHITECT Toxo IgM
section of this package insert.
assay.
• Septums MUST be used to prevent reagent evaporation and
• The ARCHITECT i System does not provide the capability to verify
contamination and to ensure reagent integrity. Reliability of assay
specimen type. It is the responsibility of the operator to verify that
results cannot be guaranteed if septums are not used according to
the correct specimen types are used in the ARCHITECT Toxo IgM
the instructions in this package insert.
assay.
• To avoid contamination, wear clean gloves when placing a septum
on an uncapped reagent bottle. Specimen Conditions
• Once a septum has been placed on the reagent bottle, do not • Do not use specimens with the following conditions:
invert the bottle as this will result in reagent leakage and may • heat-inactivated
compromise assay results. • pooled
• Over time, residual liquids may dry on the septum surface. • grossly hemolyzed (> 500 mg/dL)
These are typically dried salts, which have no effect on assay • obvious microbial contamination
efficacy. • cadaver specimens or any other body fluids
• For a detailed discussion of handling precautions during system • For accurate results, serum and plasma specimens should be free of
operation, refer to the ARCHITECT System Operations Manual, fibrin, red blood cells, and other particulate matter. Serum specimens
Section 7. from patients receiving anticoagulant or thrombolytic therapy may
Storage Instructions contain fibrin due to incomplete clot formation.
• Use caution when handling patient specimens to prevent cross
contamination. Use of disposable pipettes or pipette tips is
• The ARCHITECT Toxo IgM Reagent Kit must be stored recommended.
at 2-8°C in an upright position and may be used immediately after • For optimal results, inspect all specimens for bubbles. Remove bubbles
removal from 2-8°C storage. with an applicator stick before analysis. Use a new applicator stick
• When stored and handled as directed, reagents are stable until the for each specimen to prevent cross contamination.
expiration date. • All samples (calibrator, controls, and patient specimens) should
• The ARCHITECT Toxo IgM Reagent Kit may be stored on board the be tested within 3 hours of being placed on board the ARCHITECT
ARCHITECT i System for a maximum of 30 days. After 30 days, i System.
the reagent kit must be discarded. For information on tracking Preparation for Analysis
onboard time, refer to the ARCHITECT System Operations Manual, • Follow the tube manufacturer’s processing instructions for serum
Section 5. and plasma collection tubes. Gravity separation is not sufficient for
• Reagents may be stored on or off the ARCHITECT i System. If reagents specimen preparation.
are removed from the system, store them at 2-8°C (with septums and • Mix thawed specimens thoroughly by low speed vortexing or by
replacement caps) in an upright position. For reagents stored off the inverting 10 times. Visually inspect the specimens. If layering or
system, it is recommended that they be stored in their original trays and stratification is observed, continue mixing until specimens are visibly
boxes to ensure they remain upright. If the microparticle bottle does homogeneous.
not remain upright (with a septum installed) while in refrigerated
storage off the system, the reagent kit must be discarded. For • To ensure consistency in results, specimens must be transferred to a
information on unloading reagents, refer to the ARCHITECT System centrifuge tube and centrifuged at ≥ 10000 RCF (Relative Centrifugal
Operations Manual, Section 5. After reagents are removed from the Force) for 10 minutes before testing if
system, initiate a reagent scan to update the onboard stability timer. • they contain fibrin, red blood cells, or other particulate matter,
• they require repeat testing, or
Indications of Reagent Deterioration
• they were frozen and thawed.
When a control value is out of the specified range, it may indicate
deterioration of the reagents or errors in technique. Associated test • Transfer clarified specimen to a sample cup or secondary tube for
results are invalid and samples must be retested. Assay recalibration may testing.
be necessary. For troubleshooting information, refer to the ARCHITECT • Centrifuged specimens with a lipid layer on the top must be transferred
System Operations Manual, Section 10. to a sample cup or secondary tube. Care must be taken to transfer
only the clarified specimen without the lipemic material.
INSTRUMENT PROCEDURE
• The ARCHITECT Toxo IgM assay file must be installed on the
ARCHITECT i System from the ARCHITECT i System Assay CD-ROM
before performing the assay. For detailed information on assay file
installation and on viewing and editing assay parameters, refer to the
ARCHITECT System Operations Manual, Section 2.
• For information on printing assay parameters, refer to the ARCHITECT
System Operations Manual, Section 5.
• For a detailed description of system procedures, refer to the
ARCHITECT System Operations Manual.
• The default result unit for the ARCHITECT Toxo IgM assay is Index. An
alternate result unit, S/CO, may be selected for reporting results by editing
“Result units” to “S/CO”. The conversion formula used by the system is:
Index value ÷ 0.60 = S/CO.

3
Storage • Order tests.
• Specimens may be stored on or off the clot, red blood cells, or • For information on ordering patient specimens and controls and
separator gel for up to 3 days at 15-30°C or 14 days refrigerated for general operating procedures, refer to the ARCHITECT System
at 2-8°C. Operations Manual, Section 5.
• If specimens are stored at 15-30°C and testing will be delayed more • If utilizing ARCHITECT system software version 5.0 or higher,
than 3 days, remove serum or plasma from the clot or red blood cells refer to the ARCHITECT System Operations Manual, Section 5
and store frozen at -20°C or colder. for information on ordering patient specimens and controls, and
• If specimens are stored at 2-8°C and testing will be delayed more for general operating procedures.
than 14 days, remove serum or plasma from the clot or red blood • If utilizing an ARCHITECT system software version lower than 5.0,
cells and store frozen at -20°C or colder. use the following instructions to order patient specimens and
• No qualitative performance differences were observed between controls:
experimental controls and nonreactive or reactive specimens subjected • For information on ordering patient specimens and the positive
to 6 freeze/thaw cycles; however, multiple freeze/thaw cycles should control and for general operating procedures, refer to the
be avoided. ARCHITECT System Operations Manual, Section 5.
Shipping • Use the following instructions to order a negative control:
• Before shipping specimens, it is recommended that specimens be • Order the negative control as a patient specimen, not as
removed from the clot, red blood cells, or separator gel. a control.
• When shipping specimens, package and label specimens in compliance • Manually verify the validity of the negative control every time
with applicable state, federal, and international regulations covering it is run. Because the control is run as a patient specimen,
the transport of clinical specimens and infectious substances. a result will not be flagged by the ARCHITECT i System if
• Specimens may be shipped on wet ice or dry ice. Do not exceed the it is outside the acceptable control range. To troubleshoot
storage time limitations listed above. control values that fall outside the control range, refer to the
ARCHITECT System Operations Manual, Section 10.
PROCEDURE • The minimum sample cup volume is calculated by the system and
Materials Provided is printed on the Orderlist report. No more than 10 replicates may
• 6C20 ARCHITECT Toxo IgM Reagent Kit be sampled from the same sample cup. To minimize the effects of
Materials Required but not Provided evaporation, verify adequate sample cup volume is present before
• ARCHITECT i System running the test.
• ARCHITECT i System • Priority: 70 μL for the first ARCHITECT Toxo IgM test plus 20 μL
for each additional ARCHITECT Toxo IgM test from the same
• 6C20-01 ARCHITECT Toxo IgM Calibrator sample cup.
• 6C20-10 ARCHITECT Toxo IgM Controls • ≤ 3 hours on board: 150 μL for the first ARCHITECT Toxo IgM
• ARCHITECT i test plus 20 μL for each additional ARCHITECT Toxo IgM test
• ARCHITECT i from the same sample cup.
• ARCHITECT i • > 3 hours on board: additional sample volume is required. For
• ARCHITECT i information on sample evaporation and volumes, refer to the
• ARCHITECT i ARCHITECT System Operations Manual, Section 5.
• ARCHITECT i • If using primary or aliquot tubes, use the sample gauge to ensure
• ARCHITECT i sufficient patient specimen is present.
• Pipettes or pipette tips (optional) to deliver the volumes specified in • Prepare calibrator and controls.
the protocol. • Mix ARCHITECT Toxo IgM Calibrator and Controls by gentle
For information on materials required for maintenance procedures, refer inversion before use.
to the ARCHITECT System Operations Manual, Section 9. • To obtain the recommended volume requirements for the
ARCHITECT Toxo IgM Calibrator and Controls, hold the bottles
Assay Procedure vertically and dispense 6 drops of Calibrator 1 or 4 drops of each
• Before loading the ARCHITECT Toxo IgM Reagent Kit on the system control into each respective sample cup.
for the first time, the microparticle bottle requires mixing to resuspend • Load samples.
microparticles that have settled during shipment. After the first time the
microparticles have been loaded, no further mixing is required. • For information on loading samples, refer to the ARCHITECT
System Operations Manual, Section 5.
• Invert the microparticle bottle 30 times.
• Press RUN.
• Visually inspect the bottle to ensure microparticles are resuspended.
If microparticles remain adhered to the bottle, continue inverting the • For additional information on principles of operation, refer to the
bottle until the microparticles have been completely resuspended. ARCHITECT Operations Manual, Section 3.
• If the microparticles do not resuspend, DO NOT USE. Contact your • For optimal performance, it is important to perform routine maintenance
local Abbott representative. as described in the ARCHITECT System Operations Manual,
Section 9. Perform maintenance more frequently when required by
• Once the microparticles have been resuspended, place a septum on laboratory procedures.
the bottle. For instructions on placing septums on bottles refer to the
Handling Precautions section of this package insert. Specimen Dilution Procedures
• Load the ARCHITECT Toxo IgM Reagent Kit on the ARCHITECT Specimens cannot be diluted for the ARCHITECT Toxo IgM assay.
i System. Calibration
• Verify that all necessary assay reagents are present. • To perform an ARCHITECT Toxo IgM calibration, test Calibrator 1 in
• Ensure that septums are present on all reagent bottles. replicates of three. A single sample of each ARCHITECT Toxo IgM
• Order calibration, if necessary. control level must be tested to evaluate the assay calibration. Ensure
• For information on ordering calibrations, refer to the ARCHITECT that assay control values are within the concentration ranges specified
System Operations Manual, Section 6. in the control package insert. Calibrator 1 should be priority loaded.

4
• Once an ARCHITECT Toxo IgM calibration is accepted and stored, SPECIFIC PERFORMANCE CHARACTERISTICS
all subsequent samples may be tested without further calibration Precision
unless: The ARCHITECT Toxo IgM assay is designed to have a total** precision
• A reagent kit with a new lot number is used. of ≤ 10% CV for a positive specimen in the range of 0.60 – 2.40 Index.
• Controls are out of range. The study was performed at one internal and one external evaluation site
• It is recommended that the assay be calibrated every 30 days. each using one instrument. Precision was assessed on a panel consisting
• For detailed information on how to perform an assay calibration, refer of three different control lots and one human plasma specimen.
to the ARCHITECT System Operations Manual, Section 6. Panel members were tested in replicates of four across three reagent lots
and one calibrator lot at the external site and three calibrator lots at the
QUALITY CONTROL PROCEDURES internal site, on one instrument at each site. Each combination of panel
The recommended control requirement for the ARCHITECT Toxo IgM assay members and reagent lots was tested in four runs across several days.
is that a single sample of each control be tested once every 24 hours Data from this study are summarized in the following table*.
each day of use. If your laboratory quality control procedures require more
frequent use of controls to verify test results, follow those procedures. Mean Within Run Total**
The ARCHITECT Toxo IgM Control values must be within the acceptable Member N Index SD %CV SD %CV
ranges specified in the control package insert. If a control is out of its Negative Control 288 0.03 0.01 16.79 0.01 17.13
specified range, the associated test results are invalid and samples must Positive Control 288 1.52 0.04 2.80 0.05 3.02
be retested. Recalibration may be indicated. Human Plasma
96 1.42 0.05 3.26 0.05 3.72
Verification of Assay Claims Specimen
For protocols to verify package insert claims, refer to the ARCHITECT * Representative data; results in individual laboratories may vary from
System Operations Manual, Appendix B. The ARCHITECT Toxo IgM assay these data.
belongs to method group 5 (except functional sensitivity). ** Total is an accumulation of within run, between run and between day.
RESULTS Seroconversion Sensitivity
Calculation The assay is designed to show a seroconversion sensitivity comparable
The ARCHITECT i System calculates the Calibrator 1 mean chemiluminescent to a commercially available diagnostic kit. A total of 122 bleeds from
signal from three Calibrator 1 replicates and stores the result. Results are 39 different individuals seroconverting during acute toxoplasmosis infection
reported by dividing sample result by the stored Calibrator 1 result. The were tested. Data from seven representative seroconverting individuals
default result unit for the ARCHITECT Toxo IgM assay is Index. Sample are shown in the following table*.
results may also be reported as sample to cutoff (S/CO). Index value
divided by 0.60 equals S/CO value. Months Commer- HS
after cially Sabin- Agglu-
Interpretation of Results last ARCHITECT available Isaga Feldman tination
• Specimens with results < 0.50 Index (< 0.83 S/CO) are considered Sample negative Toxo IgM diagnostic (Toxo-M) Dye Test Test
nonreactive for IgM antibodies to Toxoplasma gondii. ID bleed [Index] kit [Index] [Index] [IU/mL] [IU/mL]
• Specimens with results ≥ 0.60 Index (≥ 1.00 S/CO) are considered Grayzone 0.50 - 0.59 0.500 - 0.599 6-8 N/A 1
reactive for IgM antibodies to Toxoplasma gondii. Reactive
• Specimens with results within the interval 0.50 ≤ x < 0.60 Index 0.60 0.600 9 2 2
cutoff
(0.83 ≤ x < 1.00 S/CO) are considered grayzone. It is recommended 30944001 0.0 0.05 0.061 0 <2 <1
to take a second sample within a reasonable period of time (e.g. two
weeks) and repeat ARCHITECT Toxo IgM testing. 30944002 1.2 0.56 0.351 4 5 1
30944003 2.1 0.89 0.588 10 800 64
Flags
30944004 2.2 0.77 0.542 10 800 64
Some results may contain information in the Flags field. For a description
of the flags that may appear in this field, refer to the ARCHITECT System 30944005 4.3 0.38 0.193 1 1600 200
Operations Manual, Section 5. 30944016 0.0 0.04 0.099 0 <2 <1
30944017 1.4 1.16 1.038 11 20 2
LIMITATIONS OF THE PROCEDURE
• If the ARCHITECT Toxo IgM results are inconsistent with clinical 30944018 1.6 1.04 0.897 10 20 4
evidence, additional testing is suggested to confirm the result. 30944019 4.1 0.52 0.380 9 10 8
• For diagnostic purposes, results should be used in conjunction with 30944033 0.0 0.04 0.218 0 <2 <1
other data; e.g., results of other tests (Toxo IgG, Toxo IgG Avidity), 30944034 2.6 1.99 2.026 12 400 64
clinical impressions, etc. 30944035 7.5 0.05 0.057 0 800 100
• Heterophilic antibodies in human serum can react with reagent 30944073 0.0 0.04 0.078 0 <2 <1
immunoglobulins, interfering with in vitro immunoassays.7 Patients
30944074 0.9 1.32 1.125 12 5 1
routinely exposed to animals or to animal serum products can be
prone to this interference and anomalous values may be observed. 30944075 1.4 2.35 1.733 12 200 16
Additional information may be required for diagnosis. 30944076 3.8 1.12 0.877 12 100 8
• Specimens from patients who have received preparations of mouse 30944086 0.0 0.30 0.437 7 2 <1
monoclonal antibodies for diagnosis or therapy may contain human 30944087 0.5 10.39 7.974 12 40 8
anti-mouse antibodies (HAMA).8,9 Specimens containing HAMA may 30944088 1.3 9.23 6.464 12 400 128
produce anomalous values when tested with assay kits (such as
ARCHITECT Toxo IgM) that employ mouse monoclonal antibodies.8 30944089 2.3 8.53 5.398 12 400 50
• Specimens from patients with high levels of IgM, e.g. from patients 30944090 0.0 0.05 0.081 0 <2 <1
with multiple myeloma, may show depressed values when tested with 30944091 1.2 5.95 4.195 12 20 2
μ-capture format assays. 30944092 1.5 5.72 3.679 12 200 16
• Human plasma collected in sodium citrate tubes cannot be used with 30944093 4.7 2.66 1.700 12 400 50
this assay, since the ARCHITECT Toxo IgM results may be affected 30944118 0.0 0.05 0.113 0 <2 <1
by this tube type.
30944119 1.0 5.76 3.784 12 2 1
30944120 1.8 6.56 3.536 12 200 64
30944121 2.5 3.88 1.910 12 1600 100
* Representative data; results in individual laboratories may vary from
these data.

5
Resolved Relative Specificity
ARCHITECT Toxo IgM
The ARCHITECT Toxo IgM assay is designed to have a resolved relative
specificity comparable to a commercially available diagnostic kit. A study Category N tested Nonreactive Reactive Grayzone
was performed at one internal and one external evaluation site. From Anti-nuclear
the 2772*** specimens evaluated to assess resolved relative specificity Antibodies (ANA)
36 specimens were concordant reactive and additional three were Unspiked 10 8 1 1
confirmed positive after discordant resolution and therefore excluded from
the specificity calculation. Hyperpolyclonal IgM
*** NOTE: Specimens that could not be resolved or showed grayzone result Spiked Reactive 10 1 8 1
interpretation on any assay being compared or used for discordant Monoclonal IgM
resolution were not included in the evaluation of resolved relative Spiked Reactive 5 4 0 1
specificity.
* Representative data; results in individual laboratories may vary from
Data from this study are summarized in the following table*. these data.
Resolved Relative Specificity After discordant resolution the unspiked ANA specimen tested reactive on
Commercially available ARCHITECT Toxo IgM could not be resolved. Specimens from patients with
ARCHITECT Toxo IgM diagnostic kit high levels of IgM, e.g. from patients with multiple myeloma, may show
Lower 95% Lower 95% depressed values when tested with μ-capture format assays. Refer to the
Confidence Confidence LIMITATIONS OF THE PROCEDURE section of this package insert.
Sample Type Observed Limit Observed Limit BIBLIOGRAPHY
99.95% 99.72% 99.95% 99.72% 1. Willis MS, Southern P, Latimer MJ. Toxoplasma infection. Making the
Pregnant Women (1987/1988) (1987/1988) best use of laboratory tests. Infect Med 2002; 19: 522-532.
Diagnostic / 100% 99.19% 100% 99.19% 2. Jones JL et al. Congenital Toxoplasmosis: A Review. CME Review
Hospital Patients (451/451) (451/451) Article Vol. 56, Number 5 2001; 296-305.
Blood Donors 100% 97.63% 100% 97.63% 3. Shulman IA. Parasitic infections and their impact on blood donor
(Serum) (154/154) (154/154) selection and testing. Arch Pathol Lab Med. 1994; 118: 366-370.
Blood Donors 98.57% 94.93% 100% 97.40% 4. Montoya J.G. Laboratory Diagnosis of Toxoplasma gondii Infection and
(Plasma) (138/140) (140/140) Toxoplasmosis. Journal of Infectious Diseases 2002; 185 (Suppl 1)
99.89% 99.68% 99.96% 99.80% 73-82.
Total (2730/2733) (2732/2733) 5. Israelski DM, Remington JS. Toxoplasmosis in the non-AIDS
* Representative data; results in individual laboratories may vary from immunocompromised host. Curr Clin Top Infect Dis 1993; 13:
these data. 322-56.
6. Wong SY and Remington. Toxoplasmosis in Pregnancy. Clinical
Interference Infectious Diseases 1994; 18:853-862.
No interference was observed between experimental controls and 7. Boscato, LM and Stuart, MC. Heterophilic antibodies: A problem for
nonreactive or reactive specimens tested with elevated levels of bilirubin all immunoassays. Clin Chem 1988; 34:27.
(20 mg/dL), triglycerides (3000 mg/dL), protein (12 g/dL), red blood cells
8. Primus FJ, Kelley EA, Hansen HJ, et al. “sandwich”-type immunoassay
(0.4% v/v), or hemoglobin (500 mg/dL).
of carcinoembryonic antigen in patients receiving murine monoclonal
Other Potential Interferants antibodies for diagnosis and therapy. Clin Chem 1988;34:261-4.
Additional studies were performed to evaluate other potential interfering 9. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine
disease states on the ARCHITECT Toxo IgM assay. Sample categories were immunoglobulin responses in patients receiving monoclonal antibody
tested both unspiked and spiked with anti-Toxo IgM positive plasma. therapy. Cancer Res 1985; 45:879-85.
A total of 167 unspiked specimens and a total of 165 spiked anti-Toxo
IgM reactive specimens were tested from the following categories: ARCHITECT and Chemiflex are trademarks of Abbott Laboratories in
Anti-nuclear antibodies (ANA), anti-dsDNA antibodies, Rheumatoid Factor, various jurisdictions.
Herpes Simplex Virus 1 (anti-HSV-1 positive), Herpes Simplex Virus 2
(anti-HSV-2 positive), Epstein-Barr Virus (anti-EBV positive), Measles,
Parvovirus B19 (anti-B19 virus positive), Varicella Zoster Virus (anti-VZV ABBOTT
positive), Rubella Virus (anti-Rubella positive), Cytomegalovirus (anti-CMV Max-Planck-Ring 2
positive), Hyperpolyclonal IgG, Hyperpolyclonal IgM, Monoclonal IgG, 65205 Wiesbaden
Germany 0088
Monoclonal IgM, Human anti-mouse antibodies (HAMA), Influenca vaccine
recipients, and Syphilis. +49-6122-580
ARCHITECT Toxo IgM showed expected qualitative results in all categories
with the exception of the categories summarized in the following table*. November 2008
© 2008 Abbott Laboratories