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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.

Device Description

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.

AI/ML Overview

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 (

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