Multicenter clinical performance evaluation of BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus

Background: BD Veritor (TM) System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a new-generation lateral flow immunochromatographic assay for objective detection of RSV in respiratory specimens from children. Objective: To evaluate the performance of BD Veritor (TM) System for Rapid Detection of RSV in respiratory specimens collected from pediatric patients. Study design: A prospective, multicenter clinical trial was undertaken at five study sites representing geographically diverse regions of the U.S. to assess the performance of the BD Veritor (TM) System for Rapid Detection of RSV in comparison to R-mix shell vial culture and ProFlu+ reverse transcription-PCR assay (Gen-Probe/Prodesse). Results: 440 nasopharyngeal washes/aspirates (NPW/A) and 706 nasopharyngeal swab (NPS) specimens from U.S. subjects <20 years of age were collected and tested using the BD Veritor (TM) System and compared with shell vial culture and real-time RT-PCR results. Analysis of the data indicates the overall sensitivity and specificity for BD Veritor (TM) System for all sample types combined was 90% and 97.0% versus shell vial culture and 75.5% and 98.7% versus RT-PCR respectively. Conclusion: Overall, the BD Veritor (TM) System for the Rapid Detection of RSV performed well when compared to both viral cell culture and RT-PCR in children. (C) 2014 Elsevier B.V. All rights reserved.