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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, nasopharyngeal swab, nasal aspirate, and nasal wash 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. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Nasal swabs, nasopharyngeal 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.

The provided text describes the QuickVue Influenza A+B test, a lateral-flow immunoassay for the rapid, qualitative detection of influenza type A and B antigens. However, the document does NOT contain information about specific acceptance criteria or an overarching study proving the device meets those criteria in terms of clinical performance (sensitivity, specificity) with real patient samples. The summary focuses on comparing the proposed device to a predicate device and an analytical study rather than a clinical one.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity or specificity targets) or report clinical performance metrics against such criteria. The "Summary of Performance Data" section describes an analytical study, not a clinical one, and its conclusion refers to the minimum detectable level of cultured viruses.

The document clearly states: "Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established." This indicates a lack of clinical study data at the time of this filing.

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

The only described study is an analytical study using "cultured viruses."

• Sample Size for Test Set: Not specified, as it's an analytical study with cultured viruses rather than a clinical test set. The study uses "cultured viruses" of specific H1N1 strains.
• Data Provenance: The study uses "cultured viruses" (seasonal H1N1 (New Caledonia/20/1999) and 2009 H1N1 (California/04/2009)). This is laboratory-derived data, not human patient data.

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

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring expert ground truth establishment from patient samples.

4. Adjudication Method for the Test Set

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring adjudication of patient results.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the performance characteristics with clinical specimens have not been established. The study mentioned is an analytical sensitivity study with cultured viruses, not involving human readers or comparative effectiveness.

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

Yes, the described "analytical study" involving cultured viruses to determine the "minimum detectable level" of the QuickVue Influenza A+B test is a standalone performance assessment of the device's ability to detect viral antigens in a controlled laboratory setting. This is a characteristic of a standalone test, as it's measuring the device's intrinsic detection capability.

7. The Type of Ground Truth Used

The ground truth for the analytical study was the presence and concentration (TCID50/ml) of specific cultured viral strains (seasonal H1N1 and 2009 H1N1).

8. The Sample Size for the Training Set

Not applicable. This device is a lateral-flow immunoassay, not a machine learning or AI-based device that typically requires a training set. The "study" described is an analytical validation.

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

Not applicable, as there is no training set for this type of diagnostic device.

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