Multicenter clinical validation of the molecular BD max enteric viral panel for detection of enteric pathogens

William Stokes, Patricia Simner, Joel Mortensen, Margret Oethinger, Kathleen Stellrecht, Elizabeth Lockamy, Tricia Lay, Peggy Bouchy, Dylan R. Pillai

Research output: Contribution to journalArticle

Abstract

The conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity. The objective of this study was to evaluate the performance of the BD Max enteric viral panel (Max EVP) assay for identification of viral pathogens in stool specimens from individuals with symptoms of acute gastroenteritis, enteritis, or colitis. Prospective and archival stool specimens from adult and pediatric patients with diarrhea were collected in Cary- Blair medium or unpreserved containers. The results for specimens tested by the Max EVP (on the BD Max platform) were compared to those obtained by the reference method (alternate PCR assays, followed by bidirectional sequencing). Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. A total of 2,239 specimens were collected, with 2,148 being included for analysis. In this population, 39.6% of specimens were from outpatients, 42.1% were from patients <21 years old, and 49.7% were from females. Prevalence rates for prospective specimens were 7.3%, 4.5%, 3.5%, 2.4%, and 1.2% for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively. PPA was 92.8%, 84.9%, 93.0%, 100%, and 95.6%, for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively. NPA was ≥99.4% for all targets. In conjunction with the clinical presentation, laboratory findings, and epidemiological information, the Max EVP assay is effective for the differential diagnosis of enteric disease caused by norovirus, sapovirus, astrovirus, rotavirus, and adenovirus. This assay can be used individually for patients at high risk for a viral enteropathogen (e.g., in outbreak settings) or as an adjunct to other enteric bacterial panels.

Original languageEnglish (US)
Article numbere00306-19
JournalJournal of clinical microbiology
Volume57
Issue number9
DOIs
StatePublished - Jan 1 2019

Keywords

  • Adenovirus
  • Astrovirus
  • BD Max
  • Enteric pathogens
  • Enteric viral panel
  • Gastrointestinal panel
  • Norovirus
  • Rotavirus
  • Sapovirus

ASJC Scopus subject areas

  • Microbiology (medical)

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  • Cite this

    Stokes, W., Simner, P., Mortensen, J., Oethinger, M., Stellrecht, K., Lockamy, E., Lay, T., Bouchy, P., & Pillai, D. R. (2019). Multicenter clinical validation of the molecular BD max enteric viral panel for detection of enteric pathogens. Journal of clinical microbiology, 57(9), [e00306-19]. https://doi.org/10.1128/JCM.00306-19