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
Conventional methodology for gastrointestinal pathogens remains time-consuming, expensive, and of limited sensitivity.
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.
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.
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 adenovirus, respectively. PPA was 92.8%, 84.9%, 93%, 100%, and 95.6%, for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively. NPA was >99.4% for all targets.
In conjunction with clinical presentation, laboratory findings, and epidemiological information, the BD MAX™ Enteric Viral Panel 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. outbreak settings) or as an adjunct to other enteric panels.