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The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. The test is intended for professional and laboratory use.

The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pinkto-red, the test is positive for influenza. Nasal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

Here's a breakdown of the acceptance criteria and study information for the QuickVue® Influenza A + B test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., a specific sensitivity or specificity percentage target). Instead, it states that "Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." This implies that the device's performance, as measured in comparison to viral culture, was deemed acceptable by the FDA for establishing substantial equivalence to predicate devices.

However, the specific quantitative performance metrics (sensitivity, specificity) from the clinical study are not provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions a "multi-clinical field study" but does not give the number of clinical specimens.
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: Retrospective. The text states: "a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study."

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

This information is not provided in the document. The ground truth was established by "viral culture." The qualifications of those performing or interpreting the viral culture are not specified.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was it done? No. This type of study is not mentioned. The device is a "standalone" or "algorithm only" type of diagnostic, meaning human interpretation is based on the visible lines on the test strip, not assisted by an AI.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? Yes, implicitly. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, which is a standalone device providing a direct result (pink-to-red test line, blue control line) without human-in-the-loop AI assistance. The clinical study evaluated the performance of this device on its own.

7. Type of Ground Truth Used

• Ground Truth: Viral culture. The text states: "Substantial equivalence has been demonstrated between the QuickVue test and viral culture..."

8. Sample Size for the Training Set

This information is not provided in the document. As this is an immunoassay and not an AI/machine learning device, the concept of a "training set" in the context of data for model development is typically not applicable. The device's "training" would be its design and optimization during manufacturing and R&D phases.

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

Not applicable, as a "training set" for an AI/ML model is not relevant for this immunodiagnostic device.

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