Multicenter clinical performance evaluation of BD Veritor™ system for rapid detection of respiratory syncytial virus

J Clin Virol. 2014 Sep;61(1):113-7. doi: 10.1016/j.jcv.2014.05.020. Epub 2014 Jun 28.

Abstract

Background: BD Veritor™ 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™ 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™ 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™ 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™ 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™ System for the Rapid Detection of RSV performed well when compared to both viral cell culture and RT-PCR in children.

Keywords: Antigen; BD Veritor; Children; PCR; RSV.

Publication types

  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Chromatography, Affinity / methods*
  • Diagnostic Tests, Routine / methods*
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Prospective Studies
  • Respiratory Syncytial Virus Infections / diagnosis*
  • Respiratory Syncytial Virus, Human / isolation & purification*
  • Reverse Transcriptase Polymerase Chain Reaction / methods
  • Sensitivity and Specificity
  • United States
  • Virus Cultivation / methods