Evaluation of diagnostic performance of bd max ebp assay in patients with diarrheal illness

Abstract

Objective: Detection of the etiological agents in patients with acute diarrhea is challenging due to a wide variety of pathogens. The aim of this study is to evaluate the diagnostic performance of BD Max Enteric Bacterial Pathogens (EBP) PCR assay in patients with diarrheal illness.Methods: Between 1 January 2014 and 31 May 2015, stool samples from pediatric or adult patients with diarrhea submitted for routine analysis of bacterial stool pathogens were included in the study. We compared the BD Max EBP PCR assay to culture for the detection of Salmonella spp., Shigella spp., Campylobacter jejuni, and Campylobacter coli and an EIA for Shiga toxins 1 and 2. Discordant results were adjudicated by either antigen detection methods or Film array GI Panel.Results: When coinfections were excluded, the positive percent agreement values for the BD Max EBP assay (PPA) was 100% and negative percent agreement (NPA) was between 98.0%-99.7%, when compared with culture and EIA. After discrepant analysis, the PPA values for the BD Max EBP assay was 100% and NPA was between 99.5%-100%.Conclusion: The BD Max EBP assay showed a high correlation rate with conventional and molecular methods for the detection of stool pathogens.