BD Gets FDA Go-Ahead to Market Veritor System for Rapid Detection of RSV

The FDA has granted 510(k) clearance and a CLIA waiver for BD Diagnostics’ nasopharyngeal swab specimens for the Veritor System for in vitro rapid detection of respiratory syncytial virus in patients from infancy to 20 years, the devicemaker said Wednesday.

The new testing method, which BD says is the first CLIA-waived RSV test system, is indicated for use in doctors’ offices, hospitals and other patient-care settings.

To perform the test, patient specimens are processed and added to the test device, where the RSV antigen binds to anti-RSV antibodies conjugated to detector particles in the test strip. The antigen-conjugate complex then moves across the strip to the reaction area and is captured by the RSV antibody line on the membrane, BD said.

The test can churn out results in 10 minutes, allowing patients to be quickly isolated from others who might have compromised cardiac or immune functions. Results are shown digitally on a hand-held reader.

The chromatographic immunoassay system uses Advanced Nano-particle and Adaptive Read technologies to detect the RSV fusion protein. The former improves the test’s sensitivity and the latter reduces false-positive results, the company said.

According to BD, RSV accounts for up to 125,000 hospitalizations per year. Early and reliable detection is critical, and the RSV assay demonstrated good performance compared with the highest reference lab based standard, said company spokesman Alberto Mas.

BD Diagnostics also markets an FDA-cleared Veritor system for diagnosing influenza A and B and Group B strep. The company expects to launch additional assays on this platform in the near future. — Lena Freund

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