(93 days)
The Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) 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 Borrelia burgdorferi IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Pretreated 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 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 an analysis of the provided information regarding the Borrelia burgdorferi IgM ELISA Test Kit, structured according to your request.
Device Name: Borrelia burgdorferi IgM ELISA Test Kit
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the provided documents do not explicitly state "acceptance criteria" as clear pass/fail thresholds. Instead, they present performance characteristics from various studies. Based on the provided data, I have inferred what could be considered the reported performance of the device in these studies.
| Acceptance Criteria (Inferred) | Reported Device Performance (Wampole Borrelia burgdorferi IgM ELISA) |
|---|---|
| Sensitivity (Agreement with Clinical Diagnosis) for Lyme Disease (CDC Panel) | 47.6% (20/42) when equivocals are considered 1-step positive. |
| Agreement with Clinical Diagnosis for Normals (CDC Panel) | 100% (5/5) |
| Agreement with Clinical Diagnosis for 1 year post-onset (CDC Panel) | 12.5% (1/8) |
| 2-step positive rate (ELISA pos/eq & Western Blot pos) among total tested in a real-world setting | 3.41% (6/176) |
| 2-step positive rate (ELISA pos/eq & Western Blot pos) among 1-step pos or eq in a real-world setting | 31.6% (6/19) |
| Inter-site precision (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).