(93 days)
The Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should 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 Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgGM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen 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, thev will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibodv. An enzyme labeled anti-human IgG/IgM 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.
Here's a breakdown of the acceptance criteria and study information for the Borrelia burgdorferi IgG/IgM ELISA Test Kit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" with specific numerical thresholds for all performance metrics. However, we can infer the desired performance and report the observed results.
| Acceptance Criterion (Inferred) | Reported Device Performance | Section from Document |
|---|---|---|
| Clinical Sensitivity (agreement with clinical diagnosis for Lyme disease) | 71% (30/42) | Wampole B. burgdorferi IgG/IgM ELISA Result |
| Clinical Specificity (agreement with negative diagnosis for normals) | 100% (5/5) | Table 1 The CDC Lyme Disease Serum Panel Stratified by Time After Onset. |
| Agreement with Predicate Device (Lyme STAT) post 2-step testing | Wampole: 4% (1.0%-6.9%) (7/176) | |
| Lyme Stat: 2.8% (0.3%-5.3%) (5/176) | Study 2: Table 2 | |
| Precision (Intersite CV) | Generally |
§ 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).