(149 days)
The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.
Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes 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 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.
The provided text describes the "QuickVue® RSV test," a lateral-flow immunoassay designed for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, aspirate, and/or nasal wash specimens in symptomatic patients 18 years of age and younger.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it implicitly uses "substantial equivalence" to a legally marketed predicate device (Binax NOW® RSV Test) as the primary criterion for acceptance.
| Performance Metric | QuickVue® RSV Test Performance (vs. Viral Culture) | Predicate Device (Binax NOW® RSV Test) | Acceptance Criterion Implied |
|---|---|---|---|
| Sensitivity | Reported as "excellent agreement" in a clinical performance study with frozen nasal washes compared to the predicate device. For the multi-center field clinical study comparing to viral culture, the specific percentage is not provided, but the conclusion is that the studies "demonstrated the substantial equivalence." | Not explicitly provided in quantifiable terms in this document. | Substantial equivalence to the predicate device. |
| Specificity | Reported as "excellent agreement" in a clinical performance study with frozen nasal washes compared to the predicate device. For the multi-center field clinical study comparing to viral culture, the specific percentage is not provided, but the conclusion is that the studies "demonstrated the substantial equivalence." | Not explicitly provided in quantifiable terms in this document. | Substantial equivalence to the predicate device. |
| Overall Accuracy | Calculated in multi-center field clinical study, but specific percentages are not provided. | Not explicitly provided in quantifiable terms in this document. | Substantial equivalence to the predicate device. |
Note: The document states "Sensitivity, specificity and overall accuracy were calculated using nasopharyngeal aspirates and nasopharyngeal swabs compared to viral culture" in the multi-center field clinical study, but the actual numerical results are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the test sets in the performance studies.
- Multi-center field clinical study: Conducted to determine sensitivity, specificity, and overall accuracy. The number of centers and overall patient count are not specified.
- Clinical performance study with frozen nasal washes: Used to demonstrate agreement with the predicate device. The sample size for this study is not specified.
- Data Provenance: The document implies the data is gathered via clinical studies, which are typically prospective in nature, but this is not explicitly stated. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The primary ground truth for the multi-center field clinical study was viral culture. This is a laboratory-based method, not reliant on human expert interpretation in the same way as, for example, reading medical images. Therefore, the concept of "experts" to establish ground truth as typically understood in AI/ML performance studies (e.g., radiologists, pathologists) is not directly applicable here for the primary ground truth.
For the comparison with the predicate device, the predicate device itself served as a reference in some capacity, but viral culture was the ultimate arbiter for accuracy.
4. Adjudication Method for the Test Set
Since the primary ground truth was viral culture, an objective laboratory method, an adjudication method for human expert disagreement (like 2+1 or 3+1) is not relevant. The viral culture result would be considered definitive.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, there is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a diagnostic test kit, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described are based on the standalone performance of the QuickVue® RSV test. The test itself is a lateral-flow immunoassay that provides a visible result (color change or line appearance). The performance studies evaluate the accuracy of this test result against a ground truth (viral culture or predicate device). There is no "human-in-the-loop" component in the interpretation of the output of the device itself; the outcome of the test (positive/negative line) is read directly. However, the application of the test is for professional and laboratory use, implying human operation and interpretation of the physical test result.
7. The Type of Ground Truth Used
- Multi-center field clinical study: Viral culture
- Clinical performance study with frozen nasal washes: Comparison to a predicate device (Binax NOW® RSV Test), implicitly using the predicate as a reference or a secondary ground truth, though viral culture is the gold standard for RSV detection.
8. The Sample Size for the Training Set
This document describes a diagnostic test kit (immunoassay) developed using traditional scientific and engineering methods, not a machine learning or AI model. Therefore, the concept of a "training set" for an algorithm is not applicable. The development of the test involves antibody selection, assay optimization, and manufacturing processes, but not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As noted above, this is an immunoassay device, not an AI/ML algorithm. Thus, there is no "training set" or "ground truth for the training set" in the context of machine learning. The specificity of the monoclonal antibodies used in the test would be established through laboratory validation against known RSV strains and other pathogens/flora during the development phase.
§ 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.