(25 days)
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.
The QuickVue Influenza A+B test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza A or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. The Test Line for influenza A or B will develop at separate specified locations on the same Test Strip. If influenza A or B antigens are not present, or are present at very low levels, only the blue procedural Control Line will appear.
Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the QuickVue® Influenza A+B test:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) for Influenza A H7N9 | To be established for H7N9 for substantial equivalence. | 7.90 x 10^6 Egg Infective Dose (EID)50/mL |
Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device and includes only one specific analytical study result for a new influenza strain (H7N9). There are no explicitly stated acceptance criteria with numerical targets for clinical performance metrics (e.g., sensitivity, specificity) within this summary. Instead, the "Conclusion" states "The QuickVue Influenza A+B test is substantially equivalent with the current QuickVue Influenza A+B test," implying that its performance should be comparable to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided text only details one analytical study for H7N9 detection. It does not specify a separate "test set" in the context of clinical samples, nor does it provide details on the sample size for this analytical study beyond the reported Limit of Detection. The data provenance (country of origin, retrospective/prospective) is also not mentioned for this analytical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The provided text describes an analytical study for Limit of Detection (LoD), which typically involves laboratory measurements and does not require expert ground truth establishment in the same way clinical studies do.
4. Adjudication Method for the Test Set
Not applicable as there is no described clinical "test set" and no method for adjudicating results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. The QuickVue® Influenza A+B test is a rapid, qualitative immunological test, not an AI-assisted diagnostic device that would involve human readers and requiring an MRMC study to assess AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the test strip and reagents) without human interpretation beyond reading the result. The QuickVue® Influenza A+B test is inherently a standalone device in this sense, as it produces visual results that are interpreted directly. The "Summary of Performance Data" details an analytical study of the device's ability to detect the H7N9 virus independently.
7. The Type of Ground Truth Used
For the analytical study concerning H7N9, the "ground truth" would be established by the known concentration of the H7N9 virus (7.90 x 10^6 EID50/mL) in the prepared samples, which is a laboratory standard rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The QuickVue® Influenza A+B test is a lateral flow immunoassay, not a machine learning or AI-based device that would require a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reasons as point 8.
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.