(35 days)
The QuickVue RSV test is a dipstick immunoassay which allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Nasopharyngeal swabs. nasopharyngeal aspirate, and nasal/nasopharyngeal wash 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 After extraction, the Test Strip is antigens. placed in the Extraction Tube for 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains RSV antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV 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® RSV test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | Not explicitly stated in the document. |
| Specificity | Not explicitly stated in the document. |
| Overall Accuracy | Not explicitly stated in the document. |
Note: While sensitivity, specificity, and overall accuracy were calculated as part of the study, the specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") and the actual calculated values are not presented in this summary document. The document only states that "A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity, specificity and overall accuracy were calculated using nasal/nasopharyngeal wash specimens compared to viral culture."
Study Information
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Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "A multi-center field clinical study" was conducted, and it involved "nasal/nasopharyngeal wash specimens." The country of origin of the data is not specified but implied to be within the US due to FDA submission. The study type is a clinical study, which typically implies prospective data collection, though this is not explicitly stated as "prospective" or "retrospective."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
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Adjudication method for the test set: Not applicable based on the provided information, as ground truth was established by viral culture rather than expert consensus on device results.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dipstick immunoassay, not an AI-powered diagnostic requiring human-in-the-loop interpretation or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the performance characteristics (sensitivity, specificity, accuracy) were calculated for the device itself as a standalone diagnostic, comparing its results to a ground truth (viral culture).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Viral culture. The summary states, "Sensitivity, specificity and overall accuracy were calculated using nasal/nasopharyngeal wash specimens compared to viral culture."
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The test relies on a lateral-flow immunoassay with pre-defined reagents.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(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 § 866.9.