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The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.

The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.

The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen 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. 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.

The Trinity Biotech Herpes Group IgG ELISA Test Kit was evaluated for its agreement with predicate devices (Clark HSV 1 and HSV 2 ELISA assays) and for precision, cross-reactivity, and paired serum study performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of predefined thresholds that the device must meet for approval. Instead, it presents performance characteristics (agreement percentages and precision) observed in comparison to predicate devices and other studies. The approval from the FDA indicates that the device's performance, as demonstrated, was deemed substantially equivalent to existing predicate devices. We can infer that the reported percentages of agreement and precision values were considered acceptable by the regulatory body for demonstrating substantial equivalence.

Based on the cumulative data from the four comparison studies with the predicate device, the key performance metrics are:

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

The primary test set for comparison with the predicate device involved sera tested across four different sites.

• Study 1 (Maryland R&D lab): 187 frozen sera (normals aged 12-83, various gender and geographical areas). Retrospective.
• Study 2 (New York R&D lab): 152 frozen sera (normals aged 17-59, various gender and geographical areas). Retrospective.
• Study 3 (Pennsylvania clinical lab): 176 prospective samples sent for Herpes antibody testing. Prospective.
• Study 4 (Wisconsin clinical lab): 88 frozen random normal samples. Retrospective.
• Total Sample Size for Primary Comparison: 603 sera (cumulative across all four studies).
• CDC Panel: A masked, characterized serum panel (details on total number not explicitly stated, but 72% positive and 28% negative samples, with 2 equivocals excluded). The origin is the Centers for Disease Control (CDC), implying a well-characterized and respected source.

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

This study does not involve human readers interpreting results or establishing ground truth based on expert consensus. The "ground truth" for the comparative studies is the result obtained from the predicate device, the Clark HSV 1 and HSV 2 ELISA assays. For the CDC panel, the "ground truth" is the CDC's characterization of the panel samples. No human experts in the traditional sense (e.g., radiologist) are described as establishing ground truth in this context; instead, the comparator assays serve this role.

4. Adjudication Method for the Test Set

Not applicable. The study compares the new device's results directly against a predicate device. There is no mention of human adjudication for discrepancies between the new device and the predicate device or a clinical outcome.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging tests or similar assessments where human readers interpret results, and the AI's impact on their performance is evaluated. The device in question is an ELISA kit, which produces quantitative results, not interpretations by human readers in the style of imaging.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented are standalone performance evaluations of the Trinity Biotech Herpes Group IgG ELISA kit. The results are generated solely by the device (the assay) and compared against a predicate device or a characterized panel. There is no human "in the loop" impacting the diagnostic output of the device itself.

7. The Type of Ground Truth Used

• For the primary comparison: The predicate device's results (Clark HSV 1 and HSV 2 ELISA assays) served as the "ground truth" or reference standard against which the new device's qualitative agreement (% agreement positive, negative, and total) was measured.
• For the paired serum study: The complement fixation (CF) method was used to determine seroconversion, serving as the ground truth.
• For the cross-reactivity study: The presence of IgG antibodies to specific viruses (EBV, CMV, VZV) was likely determined by established ELISA or other serological methods for those viruses, acting as the ground truth for non-cross-reactivity.
• For the CDC panel: The CDC's characterization of the masked serum panel served as the ground truth.

It is important to note that the document explicitly states: "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 ground truth is primarily based on concordance with another assay, not directly on clinical pathology or patient outcomes.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI development. ELISA kits are laboratory tests with defined chemical reactions and optical detection methods; they are not typically "trained" in the way AI models are. The development and optimization of the test kit itself would involve internal studies and reagent validation, but these are distinct from a typical AI training/validation set paradigm.

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

As there is no "training set" for an algorithm described, this point is not applicable. The development of the ELISA test kit relies on established biochemical principles and validation procedures to ensure the reagents and protocol accurately detect the target antibodies.

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The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.

The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group 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 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 proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Total Sample Size (Overall Comparison Study): 603 sera (excluding equivocals from individual calculations).

   • Individual Site Sample Sizes:

     • Site 1: 187 sera (181 used in calculations)
     • Site 2: 152 sera (145 used in calculations)
     • Site 3: 176 sera (170 used in calculations)
     • Site 4: 88 sera (88 used in calculations)

   • Precision Study: 7 sera, each assayed 10 times at 3 different sites (total 90 assays per serum).

   • CF Paired Serum Study: 20 serum pairs, with 11 evaluable pairs.

   • Cross-Reactivity Study: 9 serum samples containing IgG antibodies to EBV, CMV, and VZV.

   • CDC Panel: Not explicitly stated, but described as containing 72% positive and 28% negative samples.

   • Data Provenance:

     • Site 1: R&D laboratory at a commercial company in Maryland. Frozen sera from normals, ages 12-83, various genders, geographical areas. Retrospective.
     • Site 2: R&D laboratory at a commercial company in New York. Frozen sera from normals, ages 17-59, various genders, geographical areas. Retrospective.
     • Site 3: Clinical laboratory in Pennsylvania. Prospective samples sent for Herpes antibody testing. Prospective.
     • Site 4: Clinical laboratory in Wisconsin. Frozen random normal samples. Retrospective.
     • CF Paired Serum Study: From patients suspected of having acute Herpes simplex infection.
     • Cross-Reactivity Study: Serum samples containing specific antibodies.
     • CDC Panel: Serum panel obtained from the CDC.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth for the comparison study (relative sensitivity/specificity/agreement) was established by the Clark HSV 1 and HSV 2 ELISA assays (predicate device), not human experts.
   • For the CF Paired Serum Study, the ground truth was Complement Fixation (CF), a laboratory method, not human experts.
   • For the CDC panel, the ground truth was "masked, characterized serum panel" with established positive and negative samples, but the method of characterization (and thus involvement of experts) is not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • There was no stated adjudication method involving human experts for the test set. The comparison was directly against the results of the predicate device (Clark HSV 1 and HSV 2 ELISA).

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates an ELISA test kit, which is an automated diagnostic assay, and not an AI or human-assisted image interpretation tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this study represents a standalone performance evaluation of the Wampole Herpes Group IgG ELISA kit. This is an "algorithm only" (or assay-only, in this context) device designed for qualitative determination of IgG antibodies. Its performance is measured directly against a predicate device and other established lab methods, without human interpretation as part of the primary diagnostic step.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Comparison Studies: The "ground truth" was established by the predicate device, the Clark HSV 1 and HSV 2 ELISA assays. The report explicitly states: "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 means the ground truth is relative to another diagnostic test, not a definitive clinical diagnosis or pathology.
   • CF Paired Serum Study: The ground truth was based on Complement Fixation (CF) results for seroconversion.
   • Cross-Reactivity Study: The ground truth was based on known presence/absence of other specific antibodies in the serum.
   • CDC Panel: "Masked, characterized serum panel" with established positive and negative results, though specific methodology for characterization is not detailed.

7. The sample size for the training set:

   • The document does not provide information on a training set. For an ELISA kit, which is a biochemical assay rather than a machine learning algorithm, the concept of a "training set" in the AI sense is generally not applicable. Batch validation and standardization would be part of manufacturing, but not in the same way as training an AI model.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set (in the context of AI/machine learning) is described.

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