(58 days)
The Trinity Biotech Captia™ 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 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 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 assav to detect IgG/IgM 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, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. 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 and indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Borrelia burgdorferi IgG/IgM ELISA Test Kit (Trinity Biotech Captia™ Borrelia burgdorferi IgG/IgM ELISA)
Indications for Use: Qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum, for patients with signs and symptoms consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state numerical acceptance criteria in the typical sense for assay performance (e.g., "sensitivity must be >90%"). Instead, it demonstrates performance through comparative studies and precision testing. The acceptance criteria appear to be implicitly defined by demonstrating equivalence to a predicate device (BioWhittaker's Lyme STAT test) and acceptable precision, as well as testing against a characterized CDC panel and assessing cross-reactivity.
Here's a table summarizing the performance metrics and results provided:
| Performance Characteristic | Acceptance Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Agreement with Clinical Diagnosis (CDC Panel) | Demonstrate reasonable agreement with clinical diagnosis for a characterized CDC serum panel, especially for later-stage infections. | - Overall agreement (considering equivocals as positive for 1-step) with clinical diagnosis: 71% (30/42). |
- Specific agreement by time after onset:
- Normals: 100% (5/5)
- 1 year: 100.0% (8/8) |
| Equivalence to Predicate Device (Study 2) | Demonstrate similar performance to the predicate device (BioWhittaker Lyme STAT) in terms of 1-step positivity/equivocality rates and 2-step positive rates. | 1-step (ELISA) Pos. or Eq.:
- Trinity: 9.1% (4.8% - 13.4%) (16/176)
- Lyme Stat: 7.4% (3.4% - 11.3%) (13/176)
1-step Pos. or Eq. & 2-step (WB) Pos.: - Trinity: 4% (1.0% - 6.9%) (7/176)
- Lyme Stat: 2.8% (0.3% - 5.3%) (5/176)
2-step Pos. among 1-step Pos. or Eq.: - Trinity: 44% (18.9% - 68.6%) (7/16)
- Lyme Stat: 39% (11.5% - ) (5/13) |
| Precision (Inter-Assay) | Achieve precision with a Coefficient of Variation (CV)
§ 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).