(371 days)
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The acceptance criteria for the Beckman Instruments ACCESS® Toxo IgM assay and its reported performance are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 96% |
| Specificity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 99.7% |
| Resolved Sensitivity | Not explicitly stated as a numerical criterion. | 96% (after discrepancy analysis) |
| Resolved Specificity | Not explicitly stated as a numerical criterion. | 99.7% (after discrepancy analysis) |
| Specificity (in prospective population with 1.25% prevalence) | Not explicitly stated as a numerical criterion, but relative to a consensus result in a specific population type. | 99.2% |
| Intra-assay Precision (CV) | Not explicitly stated as a numerical criterion, but typically |
§ 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).