Search Results

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 wash and/or 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. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.

The QuickVue Influenza A + B 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 pink-to-red, the test is positive for influenza. 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.

Acceptance Criteria and Study for QuickVue® Influenza A + B Test

The QuickVue® Influenza A + B test is a rapid, qualitative lateral-flow immunoassay designed for the detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash, and/or nasal aspirate specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "sensitivity must be > X%, specificity must be > Y%"). However, the summary of performance data implies that "excellent sensitivity and specificity" were the desired outcomes when compared to a reference standard.

Note: The document uses descriptive terms like "excellent sensitivity and specificity" rather than specific numerical thresholds.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document states that a "multi-center field clinical study" was conducted, but it does not specify the exact sample size used for the test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the FDA, it's highly likely that a significant portion, if not all, of the clinical data was collected in the United States. The study was a "field clinical study," implying prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method

The document states that results were compared to "viral culture and discrepant results resolved by RT-PCR." This implies an adjudication method where:

• Initial Comparison: QuickVue results were compared against viral culture (the primary reference standard).
• Discrepancy Resolution: For any results where the QuickVue test and viral culture disagreed, RT-PCR was used as a tie-breaker or definitive secondary reference. This can be interpreted as a form of discrepancy resolution or "2-test" rule where viral culture is one and RT-PCR is the second for discrepant cases. It is not a typical 2+1 or 3+1 consensus method among experts on interpretations of the device results.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. This device is a rapid diagnostic test, not an AI-powered diagnostic imaging tool, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance

The primary performance study described is essentially a standalone performance study of the device. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, a diagnostic device itself, and its performance (sensitivity, specificity, accuracy) was evaluated without human interpretation being the primary variable. The results of the test strip are visually interpreted but the "algorithm" is inherent to the chemical reactions on the strip.

7. Type of Ground Truth Used

The ground truth used for the test set was:

• Viral Culture: This was the primary reference method.
• RT-PCR: Used to resolve discrepant results between the QuickVue test and viral culture. This is a highly sensitive and specific molecular method.

8. Sample Size for the Training Set

The document does not specify the sample size used for a "training set." As a lateral-flow immunoassay, the device itself is not an algorithm that requires a training set in the machine learning sense. Its design and reagents are developed through R&D, not through data-driven training of a model.

9. How Ground Truth for the Training Set Was Established

As stated above, this device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of establishing ground truth for a training set does not apply directly to this type of diagnostic device. The development of the monoclonal antibodies and assay parameters would involve extensive laboratory testing and validation using known positive and negative samples, but these are part of the R&D process rather than a "training set" for an algorithm.

Ask a specific question about this device