Key result
The BD Max enteric viral panel demonstrated high diagnostic accuracy compared to reference PCR, with positive percent agreement ranging from 84.9% to 100% and negative percent agreement ≥99.4%.
Why the study?
Conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity.
Does the BD Max enteric viral panel accurately detect viral pathogens in stool specimens from patients with diarrhea compared to reference PCR assays?
Cross-Sectional (n=2,148)
Yes
Does the BD Max enteric viral panel accurately detect viral pathogens in stool specimens from patients with diarrhea compared to reference PCR assays?
The BD Max enteric viral panel is highly accurate for detecting common viral enteric pathogens in patients with acute gastroenteritis.
Answers are grounded in this paper and cite their sources.
Supports BD Max panel for enteric virus detection in diarrhea; leaves open prospective clinical validation.
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.
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Stokes et al. (2019) conducted a cross-sectional in Acute gastroenteritis, enteritis, or colitis (n=2,148). BD Max enteric viral panel (Max EVP) assay vs. Reference method (alternate PCR assays followed by bidirectional sequencing) was evaluated on Positive percent agreement (PPA) and negative percent agreement (NPA) for viral pathogen identification. The BD Max enteric viral panel demonstrated high diagnostic accuracy compared to reference PCR, with positive percent agreement ranging from 84.9% to 100% and negative percent agreement ≥99.4%.
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