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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:

2. Sample Size Used for the Test Set and Data Provenance

The document describes two main studies for performance evaluation:

• Study 1 (CDC Lyme Disease Serum Panel):

  • Sample Size: 47 serum samples.
  • Data Provenance: The serum panel was "obtained from the CDC" and described as "masked, characterized." This suggests a retrospective panel, likely from patients previously diagnosed or classified, and potentially from diverse geographical origins within the US given CDC's role. No specific country of origin is mentioned beyond "CDC."

• Study 2 (Fresh Sera Comparative Study):

  • Sample Size: 176 fresh sera.
  • Data Provenance: "fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing." This indicates the data is prospective in terms of being "fresh sera" submitted for routine testing, but the source of the "large clinical lab" is not specified (likely US-based given the FDA submission).

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not explicitly state the number of experts used to establish the clinical diagnosis ground truth for the CDC panel. For the "characterized serum panel," the characterization would likely involve clinical diagnosis by medical professionals, potentially general practitioners or infectious disease specialists, supported by laboratory results (which could include Western blot). However, the specific number and qualifications of these experts are not provided.

For Study 2, the ground truth was ultimately established by Western blot (IgG and IgM Mardx Diagnostics Western Blot) for any sample found positive or equivocal by either ELISA. This implies that the Western blot itself served as the reference standard, and while expert interpretation of Western blots is often required, the document does not specify the number or qualifications of experts interpreting these Western blots.

4. Adjudication Method for the Test Set

The document does not describe a formal multi-reader adjudication method (like 2+1 or 3+1 consensus) for the test sets.

• For the CDC panel, the "agreement with clinical diagnosis" suggests that a pre-established clinical diagnosis (presumably the ground truth provided by CDC) was used as the reference against the ELISA results.
• For Study 2, the use of Western blot as the confirmatory second step implies a hierarchical diagnostic algorithm rather than an adjudication process between different readers or methods for the same result. The Western blot results, rather than a consensus of different interpretations, served as the ultimate arbiter for positive/equivocal ELISA results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study is primarily focused on the standalone performance of the device and its comparison to a predicate assay, not on how human readers' performance might improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The entire submission describes the performance of the Trinity Biotech Borrelia burgdorferi IgG/IgM ELISA test kit itself, as an "algorithm only" in the context of an immunoassay. The results presented in Tables 1, 2, 3, and 4 are all direct measurements of the kit's performance on various serum panels and under different conditions, without human interpretation beyond reading the photometric output and applying the assay's cutoff rules.

7. Type of Ground Truth Used

• Study 1 (CDC Panel): Clinical diagnosis (as indicated by "agreement with clinical diagnosis") and a "characterized serum panel." It is reasonable to assume this characterization includes comprehensive clinical and historical data, potentially including other laboratory tests.
• Study 2 (Comparative Study): Western blot (Mardx Diagnostics Western Blot IgG and IgM) was used as the confirmatory ground truth for samples that tested positive or equivocal by ELISA. This is a common laboratory-based reference standard for Lyme disease serology.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of submission for an immunoassay typically describes the validation of the finalized assay itself, rather than the development process involving a distinct training phase for an algorithm. The reported studies (CDC panel, fresh sera, precision, cross-reactivity) are validation studies for the device.

9. How the Ground Truth for the Training Set Was Established

Since a distinct training set is not described, the method for establishing its ground truth is not provided.

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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.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set 1 (CDC Lyme Disease Serum Panel):
  • Sample Size: 47 sera (5 normals, 42 Lyme disease patients).
  • Data Provenance: Serum panel obtained from the CDC. The text mentions "masked, characterized serum panel." This is a retrospective collection. The country of origin is not explicitly stated but implied to be the US given the CDC involvement.
• Test Set 2 (Comparative Study with Predicate):
  • Sample Size: 176 fresh sera.
  • Data Provenance: "fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing." This implies a prospective collection from a clinical lab, likely in the US.
• Test Set 3 (Precision Study):
  • Sample Size: 7 sera (tested 10 times each on 3 plates at 3 sites = 630 determinations) + 3 sera (tested 10 times each on 3 plates at 2 sites = 180 determinations) + 3 controls (HPC, LPC, NC, 15 determinations each) + 1 calibrator (CAL, 45 determinations). Total determinations mentioned as "810 determinations". The actual number of unique sera is 10.
  • Data Provenance: Not explicitly stated, but clinical lab samples are implied for the sera, likely in the US.
• Test Set 4 (Cross-Reactivity Study):
  • Sample Size: 58 samples across various potentially cross-reactive conditions (e.g., 5 lipemic, 5 bilirubinemic, 10 RPR+ etc.).
  • Data Provenance: Not explicitly stated, but likely clinical samples. No country of origin mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Test Set 1 (CDC Panel): The ground truth is described as "Clinical Diagnosis" for the Lyme disease patients and "normals" for the controls. The document doesn't specify the number or qualifications of experts involved in establishing these clinical diagnoses for the CDC panel.
• Test Set 2 (Comparative Study): The ground truth for positive/equivocal Wampole/Lyme Stat results was established by Western Blot testing (Mardx Diagnostics Western Blot on both IgG and IgM). This is a laboratory-based method, not a direct expert consensus on the diagnosis itself. The interpretation of the Western Blot, however, would typically be done by trained laboratory personnel.
• Test Set 3 & 4: Ground truth pertains to the known characteristics of the samples (e.g., known positive/negative for precision, known condition for cross-reactivity). No human experts were involved in establishing "ground truth" for the device's output to be compared against.

4. Adjudication Method for the Test Set

• Test Set 1 (CDC Panel): Not explicitly stated. The "Clinical Diagnosis" is the reference, but how that diagnosis was made or adjudicated for the panel is not detailed.
• Test Set 2 (Comparative Study): For samples that were "positive or equivocal" by either the Wampole or Lyme Stat ELISA, Western Blot (WB) was used as the confirmatory test. This serves an adjudicative role by providing a higher-tier diagnostic confirmation. There is no mention of human expert adjudication beyond the Western Blot result itself.
• Test Set 3 & 4: Not applicable, as these studies are performance characterizations against known sample properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies presented focus on the standalone performance of the device or its comparison to another device and Western blot as a gold standard, not on how human readers' performance might improve with or without AI assistance. The device is a diagnostic assay, not an AI-powered image analysis tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies are primarily standalone performance evaluations of the ELISA test kit. The ELISA is a laboratory assay that produces a quantitative (optical density) result, which is then interpreted qualitatively (positive/negative/equivocal) based on predefined cut-offs. There is no "human-in-the-loop" interaction in the sense of an AI system providing assistance. The interpretation of the ELISA results for patient management would involve human clinicians, but the performance characteristics detailed here are for the assay itself.

7. The Type of Ground Truth Used

• Test Set 1 (CDC Panel): Clinical Diagnosis. This implies a physician's assessment based on symptoms, signs, and potentially other diagnostic tests.
• Test Set 2 (Comparative Study): Western Blot (laboratory-based confirmatory test). For comparison against the ELISA, the Western Blot was used as a more definitive ground truth for antibody presence.
• Test Set 3 (Precision Study): Internal controls or characterized sera with known expected values/positivity.
• Test Set 4 (Cross-Reactivity Study): Samples characterized by the presence of specific interfering substances or conditions (e.g., "Lipemic (+++)", "RPR +", etc.).

8. The Sample Size for the Training Set

The document does not mention or describe a "training set." This device is a traditional ELISA test kit, not a machine learning or AI algorithm that requires a training phase. Its performance is based on the biochemical reaction and pre-defined cut-off values, not on a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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