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The Trinity Biotech Captia™ Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.

The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies inhuman serum to Chlamydia for the determination of immunological experience.

The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) is attached to a solid phase microtiter well. Diluted test sera are 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 is added to each well. If antibody is preset 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 text, focusing on the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance for Trinity Biotech Chlamydia IgG ELISA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance relative to a predicate device and established precision standards.

• % Agreement Negative: High agreement with predicate IFA kit.
• % Agreement: High overall agreement with predicate IFA kit. | % Agreement Positive: 92.1% (95% CI: 86.3% - 97.8%)
  % Agreement Negative: 98.0% (95% CI: 96.2% - 99.8%)
  % Agreement: 96.5% (95% CI: 94.5% - 98.5%) |
  | Precision | Coefficient of Variation (CV) 0.989 between sites.
  97.1% (133/137) agreement between three sites (excluding equivocals). |

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

• Comparative Agreement Study (Table 1):
  • Test Set Sample Size: 355 sera (86 positive by IFA, 16 equivocal by IFA, 253 negative by IFA).
  • Data Provenance: Retrospective. Sera were from "normal individuals of various ages, gender, and geographical areas." The studies were conducted at R&D laboratories of commercial companies located in Maryland and New York, affiliated with the manufacturer.
• Precision Studies (Tables 2, 3, 4):
  • Test Set Sample Size: 7 sera, each assayed 10 times in 3 different assays at 2 different sites (total 60 tests per sera for inter-site precision, 30 tests per sera for inter-assay precision within each site).
  • Data Provenance: Retrospective (sera likely selected for different activity levels), performed at 2 sites affiliated with the manufacturer.
• Paired Serum Analysis:
  • Test Set Sample Size: 9 serum pairs.
  • Data Provenance: Retrospective, serum pairs showing changes in Complement Fixation (CF) titer.
• Reproducibility Study:
  • Test Set Sample Size: 50 different sera.
  • Data Provenance: Retrospective, conducted at three different sites: two R&D laboratories at commercial companies (Maryland and New York, affiliated with the manufacturer) and one large clinical laboratory (Pennsylvania).

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

There is no mention of "experts" in the context of establishing ground truth in the traditional sense (e.g., medical professionals reviewing cases).

• For the Comparative Agreement Study: The "ground truth" for comparison was the results of a commercial IFA kit. The document states, "Please be advised that "% agreement positive" and "% agreement negative" refer to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This clarifies that the IFA kit was the reference standard, not a true clinical ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by a single predicate device (commercial IFA kit) or by the device itself for precision and reproducibility. There was no human adjudication process described. Equivocal results from the predicate IFA were excluded from agreement calculations, but this is not an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is an in-vitro diagnostic ELISA kit, not an AI-assisted diagnostic tool that requires human readers for interpretation in the manner typically associated with MRMC studies in medical imaging. The comparison is between two laboratory assays.

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

This is an inherently standalone device as it is an ELISA kit. Its performance is measured directly through its reaction with serum samples, producing a measurable color intensity that is read photometrically. The results are quantitative and then interpreted qualitatively (positive/negative/equivocal) based on pre-defined cut-offs. There is no "human-in-the-loop" once the assay is performed and read by the instrument, beyond potentially interpreting the final qualitative result.

7. The Type of Ground Truth Used

• For Comparative Agreement, Paired Serum Analysis: The ground truth was the results of a predicate commercial IFA kit (for agreement) or a Complement Fixation (CF) titer (for seroconversion) for Chlamydia. It is explicitly stated that there was no attempt to correlate the assay's results with disease presence or absence, and therefore, no true clinical or pathological ground truth was established in these comparative studies.
• For Precision and Reproducibility: "Expected results" for reproducibility were derived from "previous Trinity Biotech ELISA testing of the samples." For precision, the study aimed to evaluate the consistency of the device's own measurements.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in-vitro diagnostic kit, not a machine learning model. There is no concept of a "training set" in the context of developing this device. The development process would involve iterative optimization of assay components and protocols, rather than training an algorithm on a dataset.

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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The Chlamydia IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative detection of IgG antibodies in human serum to Chlamydia for the determination of immunological experience.

The Chlamydia IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Chlamydia. Purified Chlamydia antigen (strain LGV II) 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 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 acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance for Chlamydia IgG ELISA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

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