(29 days)
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- For In Vitro Diagnostic Use
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- 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.
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- 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.
| Acceptance Criteria (Inferred) | Reported Device Performance (SeraQuest EB VCA IgG vs. Zeus EBV VCA IgG) |
|---|---|
| High overall agreement with predicate device (Zeus EBV VCA IgG) | Overall agreement: 90.7% (with 95% CI: 85.1-96.2%) * |
*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.
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).