Search Results

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

Study Information:

1. 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 (<2 years old, 58.3%), 218 (2-5 years old, 41.7%).
       • Gender: 42.6% females, 57.4% males.
     • Reproducibility: 90 samples per condition (12 simulated RSV samples, tested by 2 operators at 3 sites for 5 consecutive days).
   • Data Provenance:
     • Analytical Studies: Performed by the manufacturer (BD).
     • Clinical Studies: Prospective multi-center clinical study conducted at eight Point-of-Care (POC) U.S. testing sites during the 2012-2013 respiratory season.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number or qualifications of experts for establishing ground truth. Instead, it relies on objective laboratory methods:
     • Analytical Sensitivity (LoD): Ground truth established based on viral culture concentrations (TCID₅₀/mL).
     • Analytical Specificity: Ground truth established based on known presence/absence and concentration of specific microorganisms.
     • Interfering Substances: Ground truth established based on known presence/absence and concentration of specific substances.
     • Clinical Studies: Ground truth for the clinical test set was established by a commercially available PCR method and viral cell culture. For discordant results between BD Veritor RSV and viral cell culture, an FDA-cleared molecular assay was used to resolve discrepancies (e.g., 23 out of 26 BD Veritor positive, culture negative specimens were confirmed RSV positive by an FDA-cleared molecular assay).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Clinical Studies: While not explicitly a "2+1" or "3+1" expert adjudication, there was a form of adjudication for discordant results between the BD Veritor RSV and viral cell culture using an FDA-cleared molecular assay as a confirmatory method. The primary comparison was against PCR and viral cell culture as reference methods.

4. 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:

   • This device is an immunoassay with an instrumented read, not an AI system interpreted by human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this device. The results are interpreted by the "BD Veritor™ System Reader" using "specific algorithms."

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, performance data for the device, which includes an instrumented read using "specific algorithms," is presented as standalone algorithm performance (without direct human interpretation of the test strip, as the reader interprets the results). The clinical study data (PPA, NPA) represents the performance of the BD Veritor™ System as a whole.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Analytical Studies: Laboratory-defined concentrations and known presence/absence of microorganisms and substances.
   • Clinical Studies:
     • Commercially available PCR method.
     • Viral cell culture.
     • FDA-cleared molecular assay (used for confirmation of discordant results between BD Veritor RSV and viral cell culture).

7. The sample size for the training set:

   • The document does not provide information on a training set sample size. This is typical for immunoassay devices where the "algorithm" is embedded in the reader based on pre-set thresholds derived from analytical validation and clinical studies, rather than a machine learning model that requires a distinct training phase with a dedicated dataset.

8. How the ground truth for the training set was established:

   • As no specific training set is mentioned for an AI/machine learning model, this information is not applicable. The "specific algorithms" within the BD Veritor™ System Reader are likely based on fixed thresholds determined during product development and analytical validation, rather than from a conventional machine learning training process with ground-truth labels.

Ask a specific question about this device