The LIAISON® Toxo IgG II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.

The LIAISON® Control Toxo IgG II (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG II assay on the LIAISON® XL Analyzer.

Device Description

The method for qualitative determination of IgG antibodies to Toxoplasma gondii (anti-Toxo IgG) is an indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Toxoplasma gondii and a conjugate of mouse monoclonal antibodies to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Toxoplasma gondii antibodies present in diluted calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjuqate reacts with anti-Toxo IgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-Toxo IqG in calibrators, samples or controls.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

AI/ML Overview

The DiaSorin LIAISON® Toxo IgG II assay is intended for the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum using chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer. The results aid in assessing a patient's serological status to Toxoplasma gondii infection and in determining the immune status of individuals, including pregnant women.

The study supporting this device's acceptance focused on comparative clinical studies against a predicate device and a CDC panel study.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative format for clinical performance (e.g., minimum sensitivity/specificity thresholds). However, substantial equivalence is claimed based on agreement with a predicate device and a CDC panel. The performance data presented indicates the device aims to accurately identify positive and negative Toxoplasma gondii IgG samples.

Here's a summary of the reported device performance from the studies:

Study Population	Performance Statistic	Reported Value
Prospective US Population	Agreement for Negative	100.0% (Exact 95% CI: 98.0-100.0%)
(vs. Comparator Assay)	Agreement for Positive	100.0% (Exact 95% CI: 84.5-100.0%)
Prospective European Population	Agreement for Negative	94.3% (Exact 95% CI: 90.9-96.6%)
Toxoplasma IgG Pregnant Population	Agreement for Negative	100.0% (Exact 95% CI: 98.0-100.0%)
(vs. Comparator Assay)	Agreement for Positive	85.7% (Exact 95% CI: 60.1-96.0%)
Retrospective Population	Agreement for Positive	100.0% (Exact 95% CI: 91.8-100.0%)
(Pre-selected positive samples)
CDC Panel Study	Sensitivity (True Positive)	100%
(vs. CDC confirmed status)	Specificity (True Negative)	100%

2. Sample Sizes and Data Provenance

Prospective US Population Test Set:
- Sample Size: 204 individuals
- Data Provenance: Prospective, US subjects sent to the lab for Toxoplasma gondii IgG testing.
Prospective European Population Test Set:
- Sample Size: 600 individuals
- Data Provenance: Prospective, European subjects sent to the lab for Toxoplasma gondii IgG testing.
Prospective Pregnant Population Test Set:
- Sample Size: 202 females
- Data Provenance: Prospective, pregnant women.
Retrospective/Pre-Selected Population Test Set:
- Sample Size: 42 individuals
- Data Provenance: Retrospective, samples from individuals with a positive Toxoplasma gondii IgG result by the comparator assay.
CDC Panel Study Test Set:
- Sample Size: 100 frozen blind specimens (70 true positive, 30 true negative)
- Data Provenance: CDC Toxoplasma 1998 Human Serum Panel.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets derived from the comparative clinical studies (US, European, Pregnant, Retrospective populations). The comparison was made against a "comparator assay" (Diamedix Is-Toxoplasma IgG ELISA). For the CDC panel study, the results were submitted to the "CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis," implying that CDC's established ground truth, likely based on expert consensus and/or confirmatory testing, was used.

4. Adjudication Method

The document does not describe a formal adjudication method for discrepancies in the comparative clinical studies. It presents agreement percentages between the new device and the comparator assay. For the CDC panel, the results were submitted to and analyzed by the CDC, which inherently implies an adjudication (or definitive classification) by that reference lab.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an automated in vitro diagnostic assay, not an imaging or interpretive AI device that would typically involve multiple human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The "Comparison to Predicate Device" section and the "Performance Data: Comparative Clinical Studies" detail the performance of the LIAISON® Toxo IgG II assay (the algorithm/device only) in comparison to a predicate device and a CDC reference panel. The results (e.g., percent agreement, sensitivity, specificity) demonstrate its performance independent of human interpretation other than reading the instrument's output.

7. Type of Ground Truth Used

For Comparative Clinical Studies (Prospective and Retrospective populations): The ground truth was established by a "comparator assay," specifically the Diamedix Is-Toxoplasma IgG ELISA (K981498). This is a form of expert consensus or reference standard based on an FDA-cleared predicate device.
For CDC Panel Study: The ground truth was based on the "CDC Toxoplasma 1998 Human Serum Panel," which had true positive and true negative samples validated by the CDC Reference Immunodiagnostic Lab. This represents a highly authoritative, verified ground truth.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For in vitro diagnostic assays, the development process (which might involve internal optimization, calibration, and iterative testing) is usually distinct from the formal clinical validation studies submitted for regulatory clearance. The provided data focuses on the validation/test sets.

9. How the Ground Truth for the Training Set Was Established

As no explicit "training set" is mentioned with details on its ground truth establishment, this information is not available in the provided text. The performance data presented relates to the validation of the finalized device, not its developmental training.

Summary

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K132234

510(k) SUMMARY

SUBMITTED BY:	Kelly R. SauerRegulatory Affairs SpecialistDiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285Phone (651) 351-5884Fax (651) 351-5669Email: kelly.sauer@diasorin.com
AUG 2 8 2013
DATE PREPARED:	July 17, 2013
NAME OF DEVICE:
Trade Name:	LIAISON® Toxo IgG IILIAISON® Control Toxo IgG II
Common Names/Descriptions:	Toxoplasma gondii IgG assay andToxoplasma gondii IgG controls
Classification Names:	Toxoplasma gondii serological reagents:Class II, 21 CFR: 866.3780; Microbiology (83)
	Single (Specified) analyte controls (assayedand unassayed): Class I, reserved21 CFR 862.1660; Clinical Chemistry (75)
Product Code:	LGDJJX
PREDICATE DEVICES :	Diamedix Is-Toxoplasma IgG ELISAReference K981498 (assay)DiaSorin LIAISON® Control Rubella IgM(K122397)

DEVICE DESCRIPTION:

INTENDED USE:

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This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

U.S. Federal Law restricts this device to sale by or on the order of a physician.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.

KIT DESCRIPTION:

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

COMPARISON TO PREDICATE DEVICE:

The DiaSorin LIAISON® Toxo IgG II assay is substantially equivalent in principle and performance to the Diamedix Is-Toxoplasma IgG ELISA (K981498) which was FDA cleared August 21, 1998. The DiaSorin LIAISON Control Toxo II is substantially equivalent in principle to the DiaSorin LIAISON Control Rubella IgM (K122397) which was FDA cleared September 6, 2012.

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Characteristic	New DeviceDiaSorin LIAISON® Toxo IgG II	Predicate DeviceDiamedix Is-Toxoplasma IgGELISA (K981498)
Intended Use	The LIAISON® Toxo IgG II assayuses chemiluminescentimmunoassay (CLIA) technology onthe LIAISON® XL Analyzer for thequalitative determination of specificIgG antibodies to Toxoplasmagondii in human serum. The resultsof this assay can be used as an aidin the assessment of the patient'sserological status to infection withToxoplasma gondii and in thedetermination of immune status ofindividuals including pregnantwomen.This assay has not beencleared/approved by the FDA forblood/plasma donor screening. U.S.Federal Law restricts this device tosale by or on the order of a licensedpractitioner. Assay performancecharacteristics have not beenestablished forimmunocompromised orimmunosuppressed patients, cordblood, neonatal specimens, orinfants.	The Diamedix Is-Toxoplasma IgGTest Kit is an enzyme-linkedimmunoassay (ELISA) for thequalitative and quantitativedetection of IgG to Toxoplasmagondii in human serum. Theresults of the assay can be used asan aid in the assessment of thepatient's immunological responseto infection with T. gondii and in thedetermination of immune status ofindividuals, including females ofchild-bearing age. The evaluationof paired sera can aid in thediagnosis of primary or reactivatedinfection. This product is not FDAcleared for use in screening bloodand plasma donors.
MeasuredAnalyte	IgG antibodies to Toxoplasma gondii	Same
Reagent Storage	On-board or in refrigerator @ 2-8°C	In refrigerator @ 2-8°C
Calibrators	Included with kit	Same
Controls	2 levels (negative and positive)	Same
Sample matrix	Human Serum	Same
Table 2 : Table of Differences
Characteristic	New DeviceDiaSorin LIAISON® Toxo IgG II	Predicate DeviceDiamedix Is-Toxoplasma IgGELISA (K981498)
Assay Type	Chemiluminescent Immunoassay	Enzyme Immunoassay
CalibrationStandarization	E6 (National Health Laboratory,France, 1987) standardized againstWHO 2nd International Standard	WHO 3rd International Standard
Calculation ofResults	Qualitative assay	Qualitative or Quantitative
Calibration	Two point verification of stored mastercurve	Single point Cut-Off Calibrator(Qualitative)Three point - 3 Standards
Unit of Measure	IU/mL	Index Value (Qualitative)IU/mL (Quantitative)
Cut-Off	≥ 8.8 IU/mL	1.10 Index Value (Qualitative)50.0 IU/mL (Quantitative)
Equivocal Zone	≥ 7.2 - < 8.8 IU/mL	0.90 - 1.09 Index Value
Sample size	20 µL	Minimum of 2 µL
Sample Handling/Processing	Automated	Manual or Automated
Assay Time	35 minutes	140 minutes
Controls	Provided Separately	Included with kit
Conjugate	Mouse monoclonal to human IgGlinked to isoluminol derivative	Goat anti-human IgG labeledwith horseradish peroxidase
MeasurementSystem	Photomultiplier (flashchemiluminescence reader)	Spectrophotometer (EIAmicrotiter plate reader)

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Table 3: Summary of Similarities and Differences LIAISONControl Toxo IgG II
Characteristic	New DeviceDiaSorin LIAISON® ControlToxo IgG II	Predicate DeviceDiaSorin LIAISON® ControlRubella IgM (K122397)
Intended Use	The LIAISON® Control Toxo IgG IIis intended for use as assayedquality control samples to monitorthe performance of the LIAISON®Toxo IgG II assay.	The LIAISON® Control Rubella IgMis intended for use as assayedquality control samples to monitorthe performance of the LIAISON®Rubella IgM assay.
Storage	Store at 2-8º C until ready to use	Same
Levels	2 levels: negative and positive	Same
Open Use	8 weeks stored at 2-8º C	Same
Matrix	Liquid human serum ordefibrinated plasma provided invials0.2% ProClin® 300	Same

PERFORMANCE DATA:

COMPARATIVE CLINICAL STUDIES:

Prospective and retrospective studies were performed to evaluate the performance of the LIAISON® Toxo IgG II assay among individuals who were sent to the lab for Toxoplasma gondii testing, pregnant women (prospective) and on frozen or repository samples from individuals with a positive Toxoplasma gondii IgG result by the comparator assay (retrospective).

A. Prospective:

The prospective populations consist of non-selected subjects sent to the laboratory for Toxoplasma gondii IgG testing (US and European subjects) and pregnant women.

The prospective US population consisting of 204 individuals were 96.1% Female (n=196) and 3.9% Male (n=8) ranging in age from 18 years to 42 years. There were 147 samples from patients where the age was unknown.

The prospective European population consisted of 600 individuals. Age and gender for these samples are unknown.

The prospective population of pregnant women consists of 202 females with ages ranging from 14 years to 44 years. There were 71 samples from subjects in the 18 trimester, 50 samples form subjects in the second trimester and 81 samples from subjects in the 3rd trimester of pregnancy.

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		Percent Agreement	Exact 95% Confidence Interval
Negative	183/183	100.0%	98.0 - 100.0%
Positive	21/21	100.0%	84.5 - 100.0%
Toxoplasma IgG Prospective European Population Comparison
		Percent Agreement	Exact 95% Confidence Interval
Negative	252/267	94.3%	90.9 - 96.6%

Toxoplasma IgG Preqnant Population Comparison

		Percent Agreement	Exact 95% Confidence Interval
Negative	188/188	100.0 %	98.0 - 100.0%
Positive	12/14	85.7 %	60.1 - 96.0%

98.8 %

B. Retrospective/PreSelected Population:

329/333

The retrospective population was defined as pre-selected samples from individuals who had a positive Toxoplasma gondii IgG result by the comparator assay. Forty two (42) samples were included in this study. The 42 individuals from the retrospective population were 95.2% females (n=40) and 4.8% males (n=2) ranqinq in age from 0 to 47 years.

96.6 - 99.5%

Toxoplasma IgG Retrospective Population

		Percent Agreement	Exact 95% Confidence Interval
Positive	42/42	100.0 %	91.8 - 100.0%

The results demonstrate that the LIAISON® Toxo IgG II assay can be used with the LIAISON® XL Analyzer for the qualitative detection of IgG antibodies to Toxoplasma aondii.

C. CDC Panel Study:

Positive

The CDC Toxoplasma 1998 Human Serum Panel is comprised of 100 frozen blind specimens (70 Toxoplasma IgG true positive samples and 30 Toxoplasma IgG true negative samples .The panel was tested by LIAISON® Toxo IgG II assay at.

The results were submitted to the CDC (Reference Immunodiagnostic Lab, Biology and Diagnostic Branch Division of Parasitic Diseases) for data analysis. As communicated by the CDC, the LIAISON® Toxo IgG II assay correctly detected the 70 Toxoplasma IgG true positive samples (100% Sensitivity) and the 30 Toxoplasma IgG true negative samples (100% Specificity).

D. Prevalence:

The observed prevalence of the LIAISON® Toxo IgG II assay was calculated for the prospective populations consisting of the 804 samples from patients sent to the lab for Toxoplasma gondii testing and 202 pregnant women.

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The prevalence may vary depending upon geographical location, age, gender, type of test employed, specimen collection and handling procedures as well as clinical history of the patient.

The observed prevalence of LIAISON® Toxo IgG II assay for the US population is 10.3%, the European population had a prevalence of 57.0% and pregnant women a prevalence of 5.9%.

PRECISION/REPRODUCIBILITY:

20 Day Study

Assay precision was evaluated according to CLSI EP5-A2. Six serum samples containing concentrations of analyte prepared to span the range of the assay and the LIAISON® Control Toxo IgG II (positive and negative) were assaved in duplicate in two runs per day over 20 operating days.

The following repeatability results were obtained from the samples tested internally at DiaSorin Inc. in one kit lot.

SampleID	N	MeanIU/mL	Within-Run		Within-Day		Between-Day		Total
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
NegControl*PosControl	80	<3.0	90.36*	5.6%*	89.13*	5.5%*	155.58*	9.6%*	200.8*	12.4%*
PosControl	80	22.8	1.19	5.2%	0.68	3.0%	0.48	2.1%	1.45	6.4%
Sample#1*	80	<3.0	151.7*	6.3%*	48.72*	2.0%*	262.18*	10.9%*	306.8*	12.8%*
Sample#2	80	7.5	0.53	7.2%	0.54	7.2%	0.00	0.0%	0.75	10.0%
Sample#3	80	15.8	0.85	5.4%	0.58	3.7%	0.41	2.6%	1.11	7.0%
Sample#4	80	13.2	0.76	5.8%	0.82	6.2%	0.14	1.1%	1.13	8.5%
Sample#5	80	27.0	1.13	4.2%	1.21	4.5%	0.70	2.6%	1.80	6.6%
Sample#6	80	76.9	4.35	5.7%	2.94	3.8%	3.16	4.1%	6.12	8.0%

Repeatability

Dose and corresponding RLU's were below the reading range of the assay. Precision calculations are based on signal (RLU) for the two samples.

The following reproducibility results were obtained from the same six samples and the LIAISON® Control Toxo IgG II (positive and negative) tested at two external sites and at DiaSorin Inc. in two kit lots assayed in duplicate in two runs per day over 20 operating days.

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Reproducibility
	Sample	Mean	Within-Run		Within-Day		Between-Day		Between Site		Total
SampleID	N	IU/mL	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
NegControl*	480	<3.00	100.82*	6.4%*	87.89*	5.5%*	147.49	9.3%*	208.12*	13.1%*	320.20*	20.2%*
PosControl	480	22.8	1.4	6.1%	0.74	3.3%	1.6	7.0%	0.7	3.1%	2.69	11.8%
Sample#1*	480	<3.00	136.38*	5.5%*	94.22*	3.8%*	215.71*	8.7%*	375.14*	15.2%*	603.16*	24.4%*
Sample#2	480	7.4	0.48	6.5%	0.33	4.5%	0.42	5.8%	0.21	2.8%	0.88	12.0%
Sample#3	480	15.3	0.79	5.2%	0.61	4.0%	0.8	5.2%	0.38	2.5%	1.72	11.2%
Sample#4	480	13.6	0.68	5.0%	0.6	4.4%	0.89	6.6%	0.44	3.2%	1.43	10.5%
Sample#5	480	26.9	1.23	4.6%	1.12	4.2%	1.43	5.3%	0.92	3.4%	2.81	10.5%
Sample#6	480	77.3	3.92	5.1%	4.42	5.7%	5.95	7.7%	2.77	3.6%	9.44	12.2%

Dose and corresponding RLUs were below the reading range of the assay. Precision calculations are based on signal (RLU) for the two samples.

CONCLUSION:

The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and it satisfies the requirements of 21CFR 809.10.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Pablic Health Service

August 28, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DiaSorin Inc. C/O Kelly Sauer, Regulatory Affairs Specialist 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

Re: K132234

Trade/Device Name: LIAISON Toxo IgG II, LIAISON Control Toxo IgG II Regulation Number: 21 CFR 866.3780 Regulation Name: Toxophasma gondii, Scrological Reagent Regulatory Class: Class II Product Code: LGD Dated: July 11, 2013 Received: July 18, 2013

Dear Ms. Sauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set

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Page 2 - Sandra Zimniewicz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Uwe Scherf -S ""

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Fitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

LIAISON® Control Toxo IgG II

LIAISON® Toxo IgG II

510(k) Number:

K132234

Device Name:

Indications For Use:

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.

Prescription Use __x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Ribhi Shawar -S

Page 1 of __ 1 __

Regulation Number and Section

§ 866.3780

Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).