Multicenter Clinical Validation of the Molecular-Based BD MAX™ Enteric Viral Panel for the Detection of Enteric Pathogens.

William Stokes, MD, Patricia J. Simner, MSc, PhD, Joel Mortensen, PhD, Margret Oethinger, MD, PhD, Kathleen Stellrecht, PhD, Elizabeth Lockamy, PhD, Tricia Lay, MS, Peggy Bouchy, PhD, Dylan Pillai, MD, PhD

Background:

Conventional methodology for gastrointestinal pathogens remains time-consuming, expensive, and of limited sensitivity.

Objective:

Performance evaluation 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.

Study Design:

Prospective and archival stool specimens were collected in Cary-Blair medium or unpreserved containers from adult and pediatric patients with diarrhea. Specimens tested via the MAX EVP (on the BD MAX™ System) were compared to reference method (alternate PCR assays, followed by bi-directional sequencing). Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated.

Results:

A total of 2,239 specimens were collected, with 2,148 included for analysis. In this population, 39.6% of specimens were from outpatients, 42.1% were from patients < 21 years, 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 ...