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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:

• 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)

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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 test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

The provided 510(k) summary for the "Borrelia burgdorferi IgG/IgM ELISA Kit" details performance characteristics but does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or precision that the device had to meet for clearance. Instead, it presents the device's performance results across various studies and implies that these results were considered acceptable by the FDA for substantial equivalence to a predicate device.

However, based on the presented data, we can infer the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria were not explicitly stated, the reported performance is presented as demonstrated.

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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.

Ask a specific question about this device