(104 days)
The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.
The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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In this document summary, the "device" refers to the MPO EIA Test Kit. The "acceptance criteria" can be inferred from the performance characteristics reported, as these values are presented as demonstrating the device's acceptable function. The primary study described is a comparative analysis against IFA and an alternate ELISA, as well as a clinical sensitivity and specificity study.
Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity (vs. IFA) | High sensitivity for detecting ANCA | 95.0% (95% CI: 85.3% - 100%) |
| Relative Specificity (vs. IFA) | High specificity for ANCA | 100% (95% CI: 98.6% - 100%) |
| Relative Agreement (vs. IFA) | High agreement with IFA | 99.6% (95% CI: 98.7% - 100%) |
| Precision (Coefficient of Variation, C.V.) | C.V.'s of less than 15% | Intra-Assay: Ranges from 2.66% to 59.49% (Samples 1-9 across 3 assays). Most samples show C.V. |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).