(42 days)
The Platelia™ Lyme IgM Assay is a qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma (K3 EDTA, sodium heparin, or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
The Platelia™ Lyme IgM Assay is a qualitative assay for the detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma.
The provided text describes the Bio-Rad Platelia™ Lyme IgM Assay and includes performance data from several studies. However, it does not explicitly define acceptance criteria for all the performance metrics presented, nor does it detail a single comprehensive study proving the device meets all acceptance criteria in the typical sense of a clinical trial for a standalone diagnostic device. Instead, it presents various performance characteristics and compares the device's results to clinical diagnoses or to a predicate device.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides acceptance criteria specifically for interfering substances. For other performance metrics, it presents observations or comparisons rather than explicitly stated acceptance thresholds.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intra-Assay Precision | Coefficient of variation (CV) 0.975 | Hemoglobin: 0.999 |
| Bilirubin: 0.999 | ||
| Triolein: 0.997 | ||
| Albumin: 0.999 | ||
| a+b: 0.85 |
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).