3 years ago

Multisite Evaluation of the BD MAX™ Extended Enteric Bacterial Panel for the Detection of Yersinia enterocolitica, Enterotoxigenic Escherichia coli, Vibrio and Plesiomonas shigelloides from Stool Specimens.

Oethinger M, Pillai DR, Mortensen J, Stellrecht KA, Leblond H, Simner PJ, Yogev R
The purpose of this study was to perform a multisite evaluation to establish the performance characteristics of the BD MAX™ Extended Enteric Bacterial Panel (xEBP) assay directly from unpreserved or Cary-Blair preserved stool specimens for the detection of Yersinia enterocolitica, Enterotoxigenic Escherichia coli (ETEC), Vibrio and Plesiomonas shigelloides The study included prospective, retrospective and prepared contrived specimens from 6 clinical sites. BD MAX™ xEBP results were compared to the reference method which included standard culture techniques coupled with alternate PCR and sequencing, except ETEC for which the reference method were two alternate PCRs and sequencing. Alternate PCR was also used to confirm the historical results for the retrospective specimens and for discrepant results analysis. A total of 2,410 unformed, de-identified stool specimens were collected. The prevalence in the prospective samples as defined by the reference method was: 1.2% ETEC, 0.1% Vibrio, 0% Y. enterocolitica, and 0% P. shigelloides Compared to the reference method, the PPA (95% CI), NPA (95% CI) and Kappa coefficient (95% CI) for the BD MAX™ xEBP assay for all specimens combined were: ETEC - 97.6% (87.4-99.6), 99.8%(99.5-99.9), 0.93 (0.87-0.99); Vibrio - 100% (96.4-100), 99.7% (99.4-99.8), 0.96 (0.93-0.99); Y. enterocolitica - 99.0% (94.8-99.8), 99.9% (99.8-99.9), 0.99 (0.98-1) and P. shigelloides - 100% (96.4-100), 99.8% (99.5-99.9), 0.98 (0.95-1). In this multicenter study, the BD MAX™ xEBP showed a high correlation (kappa: 0.97, 95%CI: 0.95-0.98) to the conventional methods for the detection of ETEC, Vibrio, Y. enterocolitica, and P. shigelloides in stool specimens from patients suspected of acute gastroenteritis, enteritis or colitis.

Publisher URL: https://www.ncbi.nlm.nih.gov/pubmed/28878009

DOI: PubMed:28878009

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