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The ViraZyme® Influenza ID test is a direct specimen test indicated for use in the qualitative detection of both influenza types A and B virus from throat swab specimens. The ViraZyme® Influenza ID test may be used when a patient is suspected of having symptoms of an influenza-like illness. These symptoms can include, but are not limited to the following: fever of 38.5℃, sore throat, headache, myalgia, rhinitis, vomiting, chills, malaise, and cough. A positive ViraZyme® result would indicate the presence of influenza type A or B virus. A negative result is considered presumptive and should be confirmed by culture. The ViraZyme® Influenza ID test does not detect influenza C, and is indicated for in Vitro Diagnostic Use only.

The ViraZyme® Influenza ID Test for Influenza Types A and B Viruses is an endogenous viralencoded enzyme assay (EVEA) and is intended for use in the qualitative determination of influenza types A and B from throat swab specimens. The ViraZyme® Influenza ID Test is not intended for the detection of influenza C.

Influenza types A and B virus possess surface glycoproteins with neuraminidase activity, that hydrolyze substrates which contain alpha-ketosidically linked N-acetylneuraminic acid (Neu5Ac). A modified Neu5Ac molecule has been synthesized and coupled to a chromogen to produce the neuraminidase substrate. In the presence of influenza types A and B virus the chromogenic substrate is then cleaved by the action of viral neuraminidase, releasing a free chromogen. This free chromogen precipitates to produce a blue color. The blue precipitate is then concentrated and collected from the reaction mixture onto a filter device.

ViraZyme® Influenza ID Test: Acceptance Criteria and Performance

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria. However, it presents the clinical performance of the ViraZyme® Influenza ID Test against a reference method. Based on the reported results, we can infer the achieved performance metrics.

Note: The inferred "Acceptance Criteria" are based on the typical expectations for in vitro diagnostic tests used as screening tools, where high specificity is often prioritized to minimize false positives, and sensitivity is acceptable for a screening test that would be confirmed by a more definitive method. The 100% reproducibility is explicitly stated as demonstrating adequate performance across different environments.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 157 throat swab specimens.
• Data Provenance: The data was collected from field sites across the United States during the 1995-96 influenza season (November 11, 1995 to March 29, 1996). This was a prospective study, as specimens were collected specifically for this evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., number of years of experience). However, it mentions that the reference method involved "viral isolation and culture confirmation with monoclonal antibodies" which is a laboratory-based gold standard. This process would typically be performed and interpreted by trained laboratory personnel, likely microbiologists or virologists, with expertise in viral culture and identification.

4. Adjudication Method

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was established by a single reference method: viral isolation and culture confirmation with monoclonal antibodies. There is no indication of multiple expert readings or a consensus process for the reference method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses solely on the standalone performance of the ViraZyme® Influenza ID Test compared to a laboratory reference method. There is no mention of human readers' performance with or without AI assistance, as this is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The entire clinical evaluation described in the document assesses the ViraZyme® Influenza ID Test's performance (algorithm/assay only, without human-in-the-loop interpretation impacting the result) against the reference method. The reported sensitivity and specificity values are for the device's standalone performance.

7. Type of Ground Truth Used

The type of ground truth used was viral isolation and culture confirmation with monoclonal antibodies. This is considered a highly reliable and definitive method for identifying influenza viruses.

8. Sample Size for the Training Set

The document does not provide any information regarding a distinct training set sample size. The clinical study described in the document appears to be solely for validation/testing purposes. It's possible that the device's development involved internal studies or smaller pilot data not mentioned in this summary, but no details are provided.

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

As no information regarding a separate training set is provided, there is no information on how its ground truth would have been established.

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