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• 1. For In Vitro Diagnostic Use
• 2. For the qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay.
• 3. For use as an aid in differentiating active or recent infection, from past infection.

The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum. The Calibrators in the SeraQuest EB VCA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Acceptance Criteria and Device Performance Study for SeraQuest EB VCA IgG

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the SeraQuest EB VCA IgG device. Instead, it presents results and compares them to a predicate device. Based on the "Overall agreement" calculated, we infer that an agreement level with the predicate device was the primary metric of performance.

*Excluding equivocal results.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 113 serum samples.
• Data Provenance: Not explicitly stated, but the study compares the SeraQuest device to a predicate device (Zeus EBV VCA IgG) using "serum samples." The document is from a US regulatory submission, suggesting the data may be from the US, but this is not confirmed. The data appears to be retrospective as it compares the new device's performance against existing results from another test.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not applicable. The ground truth for this study was established using a predicate device's results, not expert interpretation of samples.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The comparison was directly against the results of the predicate device (Zeus EBV VCA IgG), not against a consensus of human readers.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device, not to human readers with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was conducted. The SeraQuest EB VCA IgG device's performance (specifically its agreement with the predicate device) was evaluated independently. The table detailing the "Results of SeraQuest VCA IgG Assays (Modified Device) and Zeus VCA IgG Assays on 113 Serum Samples" directly shows the device's output against the predicate device's output.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by the results of a predicate device (Zeus EBV VCA IgG Test System). The predicate device's results were used as the reference against which the SeraQuest device's performance was measured.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This device is a diagnostic assay (solid-phase enzyme immunoassay, EIA), not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" or development of such a device involves chemical and biological optimization, not data-driven model training.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable, as it's not an AI/machine learning device with a training set. The development of the assay would have involved standard laboratory methods and internal validation to optimize its components and ensure it accurately detects IgG antibodies to Epstein-Barr virus capsid antigen.

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1. For in vitro diagnostic use only.
2. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
3. For use as an aid in differentiating active or recent infection, from past infection.
4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus capsid antigen.

The provided text describes the SeraQuest EB VCA IgG test, an Enzyme Immunoassay (EIA) for detecting IgG antibodies to Epstein-Barr virus capsid antigen (VCA) in human serum. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Gull Laboratories' EBV IgG ELISA test.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or overall agreement. Instead, it presents the device's performance in comparison to a predicate device and implicitly uses these results to support substantial equivalence. The predicate device's performance is not exhaustively detailed, but the comparison implies that the SeraQuest EB VCA IgG test should perform comparably.

*Excluding equivocal results.

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

• Sample Size: 157 specimens.
• Data Provenance: The study was "performed in-house at Quest International, Inc., Miami, FL." The country of origin of the samples is not specified, but the testing location is in the USA. The design is retrospective, as existing specimens were "tested" with both devices.

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

The study uses the Gull Laboratories' EBV IgG ELISA test as the comparator or "reference" for evaluating the SeraQuest device's performance, not an expert panel. Therefore, no information on the number or qualifications of experts used to establish a separate "ground truth" is provided. The Gull test essentially acts as the 'ground truth' in this comparative study for regulatory purposes.

4. Adjudication Method for the Test Set

No explicit adjudication method is described. The comparison is straightforward: results from the SeraQuest test are compared directly against results from the Gull Laboratories' test. Where discrepancies occurred (e.g., equivocal results), they are reported, but no further expert adjudication process is detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an in vitro diagnostic (IVD) device, specifically a serological assay, which typically does not involve human readers interpreting images or data in a way that an MRMC study would assess.

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

Yes, this was a standalone study. The SeraQuest EB VCA IgG test is an enzyme immunoassay designed for qualitative and semi-quantitative detection of antibodies. The results are generated by the assay process itself, and its performance (sensitivity, specificity, agreement) is reported solely based on its output compared to the predicate device. There is no human interpretation or intervention in the algorithm's performance being assessed.

7. Type of Ground Truth Used

The "ground truth" for this study was established by the predicate device, the Gull Laboratories' EBV IgG ELISA test. The study aims to show substantial equivalence, meaning the SeraQuest device's results align closely with those obtained from the already legally marketed Gull test. There is no mention of pathology, clinical outcomes data, or expert consensus being used as a separate, independent ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" or "validation set" in the context of machine learning, as this device is a traditional immunoassay. Therefore, this question is not applicable based on the provided text. The numbers given (157 specimens) refer to the clinical evaluation or test set.

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

As there is no mention of a training set, the method for establishing its "ground truth" is not applicable based on the provided text.

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