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.
Highlights
The conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity
Specimens were excluded if they had one or more of the following: were from solid or formed stools, were collected from rectal swabs, were improperly collected, were submitted only for Clostridioides difficile testing from patients suspected of C. difficile infection, or were collected from patients who had already tested positive for a viral enteropathogen
Of the Max enteric viral panel (Max EVP) reportable specimens, 178, 232, 212, 155, and 188 specimens were nonevaluable by the reference method (RM) for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively (Fig. 1)
Summary
The conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity. 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. (Cryptosporidium parvum and Cryptosporidium hominis), and Entamoeba histolytica [7, 8]; and the BD Max enteric viral panel (Max EVP), which detects norovirus genogroup I (GI) and GII, rotavirus type A, adenovirus type F 40/41, human astrovirus (hAstro), and sapovirus (genogroups I, II, IV, and V) The aim of this multisite study was to evaluate the performance of the Max EVP assay for its use in determining the presence of enteric viral pathogens from Cary-Blair medium-preserved or unpreserved stool specimens collected from individuals with symptoms of acute gastroenteritis, enteritis, or colitis. (These data were presented at the 29th European Congress of Clinical Microbiology & Infectious Diseases, Amsterdam, Netherlands, 13 to 16 April 2019.)
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