(37 days)
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigens Proteinase 3 (PR-3) and myeloperoxidase (MPA) in human serum. The presence of these antibodies, In combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA). Since a positive test result with this assay does not indicate which ANCA is (are) present, all positives should be confirmed using assays designed for particular ANCA specificities.
An enzyme-linked immunosorbent assay (ELISA) designed for the detection of autoantibodies to the antigens Proteinase 3 and mveloperoxidase in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 and Myeloperoxidase antigens have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigens and remain in place after a wash step. A second antibody which is conjucated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.
The provided text describes the VIRGO® ANCA SCREEN Kit, an enzyme-linked immunosorbent assay (ELISA) for detecting autoantibodies to Proteinase 3 (PR3) and myeloperoxidase (MPO) in human serum.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds prior to presenting results, but rather demonstrates performance through comparison to predicate devices and precision studies. Therefore, I will derive the implied acceptance criteria from the context of "Comparison Testing" and "Precision" sections.
| Acceptance Criteria (Implied) | Reported Device Performance (VIRGO® ANCA SCREEN Kit) |
|---|---|
| Relative Sensitivity (against predicate device for positive panels) | 100.0% (35/35, 90.1% to 100% confidence interval) |
| Relative Specificity (against predicate device for normal samples) | 100.0% (66/66, 94.5% to 100% confidence interval) |
| Inter-assay Precision (samples 1-6 %CV) | 9.3% - 12.7% |
| Inter-assay Precision (controls %CV) | 7.5% - 14.9% (for cANCA and pANCA positive controls), 8.5% (for Cutoff Serum) |
| Intra-assay Precision (samples 1-6 %CV) | 4.6% - 14.0% |
| Interfering Substances (Hemoglobin variation) |
§ 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).