Search Results

For in vitro diagnostic use only.
For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay.
May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.

The SeraQuest EB NA 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 nuclear antigen, in human serum.

The Calibrators in the SeraQuest EB NA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's an analysis of the provided text regarding the SeraQuest® EB NA IgG device, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SeraQuest EB NA IgG test were established relative to the predicate device, Gull Laboratories' EBNA IgG ELISA test. The performance metrics are reported as relative sensitivity, relative specificity, and overall agreement.

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

• Sample Size: 157 archival serum specimens.
• Data Provenance: The specimens included:
  • 80 from patients whose sera were submitted to a clinical laboratory for EBV serological testing.
  • 11 from donors reported to be positive for EBV antibodies, obtained through serum brokers.
  • 66 from normal serum donors.
  • The term "archival serum specimens" suggests a retrospective nature for the study. The country of origin is not explicitly stated, but the applicant (Quest International, Inc.) is based in North Miami, FL, USA.

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

The ground truth for the test set was established by the predicate device, the Gull Laboratories' EBNA IgG test. Therefore, no human experts were explicitly used to establish ground truth in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. The study compared the new device (SeraQuest EB NA IgG) directly against a predicate device (Gull Laboratories' EBNA IgG test). There was no adjudication process involving multiple human readers to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study compares a new in-vitro diagnostic device to a predicate in-vitro diagnostic device, not human readers with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The SeraQuest EB NA IgG test is an in-vitro diagnostic kit and its performance was evaluated directly without human interpretation as part of the primary outcome measure, other than following manufacturers' instructions.

7. The Type of Ground Truth Used

The ground truth for this comparison study was established by the performance of the predicate device, the Gull Laboratories' EBNA IgG ELISA test.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this submission. The SeraQuest EB NA IgG test is a laboratory kit, not an AI/machine learning algorithm requiring a training dataset. The submission focuses on the analytical and clinical performance of the manufactured kit.

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

Not applicable, as there was no training set.

Ask a specific question about this device