(42 days)
For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.
The SeraQuest VCA IgM 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 IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.
The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Here's a breakdown of the acceptance criteria and study details for the SeraQuest® VCA IgM device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria for the SeraQuest® VCA IgM device beyond the 'Overall agreement' percentage. It primarily demonstrates substantial equivalence to a predicate device using comparative clinical testing.
Table 1. SeraQuest® VCA IgM Performance Against Zeus' EBV-VCA IgM EIA Test
| Metric | Acceptance Criteria (Implied) | Reported Performance (SeraQuest® VCA IgM) |
|---|---|---|
| Overall Agreement | Not explicitly stated | 99.0 % |
| 95% Confidence Interval | Not explicitly stated | 97.3 to 100 % |
Note: The acceptance criteria here are inferred from the reported overall agreement, as no specific quantitative thresholds were explicitly defined in the document for FDA clearance.
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 113 specimens
- Data Provenance: Archival patient specimens tested at SeraQuest, Miami, FL (United States). The study is retrospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications used to establish the ground truth. Instead, the predicate device (Zeus' EBV-VCA IgM ELISA test) served as the comparator for the test set.
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Adjudication Method:
- The document does not describe a specific adjudication method such as 2+1 or 3+1. The results of the SeraQuest test were directly compared against the results of the Zeus' EBV-VCA IgM ELISA test.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This study is a comparison of a new diagnostic device against a predicate device, not a study of human reader improvement with or without AI assistance.
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Standalone Performance Study:
- Yes, a standalone performance study was conducted. The SeraQuest VCA IgM device's performance was evaluated by testing 113 archival patient specimens and comparing its results directly with those obtained from the predicate device (Zeus' EBV-VCA IgM ELISA test). This represents the algorithm/device's performance without human intervention in the result interpretation beyond what is inherent in reading an EIA test.
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Type of Ground Truth Used:
- The "ground truth" for this study was established by the results obtained from the predicate device, Zeus' EBV-VCA IgM ELISA test. This is a comparative study where the predicate device's results serve as the reference.
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Sample Size for the Training Set:
- The document does not provide information on a training set or its sample size. As this is a diagnostic device comparison for substantial equivalence, it's likely a fully developed product was tested, not one undergoing a machine learning training phase.
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How the Ground Truth for the Training Set was Established:
- Since no training set information is provided, the method for establishing its ground truth is also not available.
§ 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).