(93 days)
The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 6 years. 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 viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.
The BD RSV test is a chromatographic assay to qualitatively detect RSV fusion protein in samples processed from respiratory specimens. The processed specimen is added to the test device where RSV viral antigen binds to anti-RSV antibodies conjugated to detector particles on the RSV test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.
Here's a summary of the acceptance criteria and study details for the BD Veritor™ System for Rapid Detection of RSV, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LoD) | Lowest concentration producing ≥95% positivity. | VR-26 (Long Subgroup A): 1.43X10⁵ TCID₅₀/mL (95.0%) |
| VR-955 (9320 subgroup B): 3.98X10⁴ TCID₅₀/mL (95.0%) | ||
| VR-1540 (A-2): 1.94X10³ TCID₅₀/mL (98.3%) | ||
| VR-1580 (Washington subgroup B): 1.08X10⁴ TCID₅₀/mL (96.7%) | ||
| VR-1400 (Wild Type subgroup B): 2.96X10³ TCID₅₀/mL (95.0%) | ||
| Analytical Specificity (Cross-Reactivity) | No cross-reactivity with common bacteria/yeast (5x10⁸ CFU/mL) and viruses (10⁶ TCID₅₀/mL). | None of the tested microorganisms showed cross-reactivity. |
| Interfering Substances | No interference from specified substances at given concentrations. | No interference noted for any of the tested substances. |
| Clinical Performance (vs. PCR) | Positive Percent Agreement (PPA) with PCR. | 81.6% (95% C.I: 75.2%, 86.6%) |
| Negative Percent Agreement (NPA) with PCR. | 99.1% (95% C.I: 97.5%, 99.7%) | |
| Clinical Performance (Invalid Rate) | Overall invalid rate. | 0.2% (1/523, 95% C.I: 0.03%, 1.07%) |
| Reproducibility | Consistent results across sites, operators, and days for various sample types. | High negative RSV: 8.9% positive (8/90 total) |
| Low positive RSV: 82.2% positive (74/90 total) | ||
| Moderate positive RSV: 100% positive (90/90 total) | ||
| Negative: 0% positive (0/90 total) |
Study Information:
- Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Analytical Sensitivity (LoD): 60 or more replicates per viral strain. For VR-1400, 80 replicates were used.
- Analytical Specificity: Bacteria/yeast tested at approx. 5 x 10⁸ CFU/mL; viruses at 10⁶ TCID₅₀/mL or greater. Specific numbers of tests for each microorganism are not given, but a list of ~40 bacteria/fungi and ~20 viruses were tested.
- Interfering Substances: Specific concentrations for each substance listed. Number of tests per substance not explicitly stated.
- Clinical Studies: 523 evaluable specimens (out of 540 collected).
- Age distribution: 305 (
- Test Set Sample Size:
§ 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.