(63 days)
For the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.
The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
The & Borrelia burgdorferi IgM ELISA Kit is an enzyme-finked immunosorbent assay (ELISA) for the detection of IgM to Borrelia burgdorferi antigen in human serum.
Here's a breakdown of the acceptance criteria and study information for the Borrelia burgdorferi IgM ELISA Kit, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative or numerical format (e.g., "Sensitivity must be >X%"). Instead, it presents performance data for comparison against other methods or expected clinical behavior. For example, it provides agreement percentages with characterized serum panels and precision values.
Therefore, the table below will summarize the provided performance characteristics rather than predefined acceptance criteria. The implied acceptance is that these performance characteristics are adequate for the intended use and comparable to similar devices (as suggested by the substantial equivalence to "Zeus Lyme Elisa").
| Performance Metric | Reported Device Performance |
|---|---|
| Clinical Sensitivity (CDC Panel) | 40.4% agreement (equivocals considered positive) overall |
| > 1 Yr from onset | 12.5% agreement |
| 3 - 12 Months from onset | 45.0% agreement |
| 1 - 2 Months from onset | 33.3% agreement |
| 1 Yr from onset | 66.7% agreement |
| 3 - 12 Months from onset | 84.6% agreement |
| 1 - 2 Months from onset | 69.2% agreement |
§ 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).