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BD Diagnostics’ Veritor system for rapid detection of RSV wins 510(k) clearance and CLIA waiver

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for nasopharyngeal swab specimens on the BD Veritor system for rapid detection of Respiratory Syncytial Virus (RSV).

This is the first commercially available rapid CLIA-waived RSV test system that incorporates a digital result. The new assay is cleared for use in physician offices, hospitals, and other patient-care settings.

BD Diagnostics Diagnostic Systems president Alberto Mas said early and reliable detection of RSV is critical among high-risk populations to treat and prevent the spread of this contagious virus and hospitalizations.

"The CLIA-waived BD Veritor System for Rapid Detection of RSV has demonstrated good performance when compared to PCR, the highest reference lab based standard, while providing an objective test result in only 10 minutes," Mas added.

When used in conjunction with the BD Veritor System Reader, the RSV test utilizes Advanced Nano-particle and Adaptive Read technologies to obtain an accurate result while providing objective results on a hand held reader with an easy-to-read digital display.

The Advanced Particle Technology along with improved chemistries helps improve the sensitivity of the test while the Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity.

This digital immunoassay (DIA) for rapid detection of RSV offers healthcare professionals a new option for RSV testing versus current visual read CLIA-waived assays.

The BD Veritor system for rapid detection of RSV is the third CLIA-waived offering and BD plans to launch additional FDA-cleared assays on this platform.