(261 days)
- For in vitro diagnostic use only.
- For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
- For use as an aid in differentiating active or recent infection, from past infection.
- 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.
| Performance Metric | SeraQuest EB VCA IgG Performance (vs. Gull VCA IgG Assay) | Implicit Acceptance Criterion (based on predicate device comparison) |
|---|---|---|
| Relative Sensitivity* | 92.2% (95% CI: 87.8 to 96.6) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
| Relative Specificity* | 90.0% (95% CI: 71.4 to 100) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
| Overall Agreement* | 92.1% (95% CI: 87.7 to 96.4) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
*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.
§ 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).