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The QuickVue RSV 10 test is an immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens for symptomatic pediatric patients (less than six years old). The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by cell culture. The test is intended for professional and laboratory use.

The QuickVue RSV 10 test is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for RSV antigens. The test is specific to RSV antigen with no known cross-reactivity to normal flora or other known respiratory pathogens. Nasopharyngeal swabs and nasopharyngeal aspirate/wash serve as specimens for this test. For a liquid specimen such as a nasopharyngeal aspirate/wash, the specimen is added directly to the reagent tube and rehydrates the reagent. When a nasopharyngeal swab is used, the reagent is first rehydrated with the provided reagent solution and the swab specimen is then inserted into the reagent tube. The reagent interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The test strip is placed in the reagent tube for 10 minutes. During this time, the specimen will react with the reagents in the test strip. If the specimen contains RSV antigens, a pink-to-red Test Line, along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If RSV antigen is not present, or is present at very low levels, only a blue procedural Control Line will appear.

The QuickVue® RSV 10 is an immunoassay for rapid, qualitative detection of respiratory syncytial virus (RSV) antigen in nasopharyngeal specimens from symptomatic pediatric patients (less than six years old).

Here's an analysis of its acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity/specificity thresholds). Instead, it presents the performance data against a predicate device and states that "These studies demonstrated the substantial equivalence of the QuickVue RSV 10 test to existing products already marketed." Substantial equivalence is the primary regulatory standard for 510(k) devices.

To infer the performance that was found acceptable, we look at the provided comparator data. The "Summary of Performance Data" indicates that sensitivity and specificity were calculated against viral culture, which is generally considered the gold standard for RSV detection at the time of this submission. While the exact numerical performance metrics (sensitivity, specificity) are not provided in the snippet, their calculation against viral culture is highlighted as a key study.

Table of Performance (Based on information provided, specific values are not available in the extract):

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text for the multi-center field clinical study.
• Data Provenance: The multi-center field clinical study implies data was collected from multiple clinical sites. The country of origin is not specified but given the submitter (Quidel Corporation, San Diego, CA) and the FDA filing, it is likely the U.S. The study was a prospective multi-center field clinical study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The study focuses on the device's performance against a gold standard (viral culture) and its equivalence to a predicate device, not on how human readers improve with AI assistance (as this is not an AI device).

6. Standalone Performance

Yes, a standalone performance study was done. The "multi-center field clinical study" aimed to "document the performance characteristics of the test," including sensitivity and specificity, by comparing the device's results directly to viral culture. This is a standalone assessment of the algorithm's (or, in this case, the test's) ability to detect RSV.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was viral culture.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this is not an AI/ML device. It's a serological immunoassay. Therefore, there's no training set in that sense. The analytical studies involved panels of test samples at various RSV concentrations for reproducibility and analytical performance, but these are not a "training set."

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

As noted above, there is no "training set" in the AI/ML context for this device. For the analytical studies, the ground truth was established by preparing test samples with known RSV concentrations.

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