Gastrointestinal infection (GI) - November 01, 2017

Multisite evaluation of the BD MAX™ Extended Enteric Bacterial Panel

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

Patricia J Simner 1Margret Oethinger 2Kathleen A Stellrecht 3Dylan R Pillai 4Ram Yogev 5Helene Leblond 6Joel Mortensen 7

November 2017


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 for ETEC, for which the reference method was two alternate PCRs and sequencing.

Alternate PCR was also used to confirm the historical results for the retrospective specimens and for discrepant result analysis. A total of 2,410 unformed, deidentified 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 positive percent agreement (PPA) (95% confidence interval [CI]), negative percent agreement (NPA) (95% CI), and kappa coefficient (95% CI) for the BD MAX™ xEBP assay for all specimens combined were as follows: ETEC, 97.6% (87.4 to 99.6), 99.8% (99.5 to 99.9), and 0.93 (0.87 to 0.99); Vibrio, 100% (96.4 to 100), 99.7% (99.4 to 99.8), and 0.96 (0.93 to 0.99); Y. enterocolitica, 99.0% (94.8 to 99.8), 99.9% (99.8 to 99.9), and 0.99 (0.98 to 1); P. shigelloides, 100% (96.4 to 100), 99.8% (99.5 to 99.9), and 0.98 (0.95 to 1), respectively.

In this multicenter study, the BD MAX™ xEBP showed a high correlation (kappa, 0.97; 95% CI, 0.95 to 0.98) with the conventional methods for the detection of ETEC, VibrioY. enterocolitica, and P. shigelloides in stool specimens from patients suspected of acute gastroenteritis, enteritis, or colitis.

Copyright © 2017 American Society for Microbiology.

Access the full publication


By reading this content you are acknowledging our forward looking statement.

Why join BD MAX™ Club?

Connect with professionals from around the world BD MAX™ Club members represent a community of professionals in infectious diseases and molecular diagnostics. With regional meet-ups and live webinars from global experts, expand your laboratory’s network and collaborate with worldwide colleagues.

Tailored medical and technical expertise Whether you need compelling scientific research or tutorials for troubleshooting on the BD MAX™ System, BD MAX™ Club is here to accompany your molecular diagnostics journey. Log in to your BD MAX™ Club account anywhere, anytime to access our information database.

Exclusive members’ perks BD MAX™ Club membership unlocks doors to exclusive webinars and collaboration with industry leading experts. Engage with your colleagues in the molecular community and exchange with the BD research and development team.

More scientific content

Forward Looking Statement

The information included on this website and other information provided from time to time through webcasts, conference calls, securities analyst meetings, road show presentations, investor conferences, newsletters and similar events and communications contains forward-looking statements (as defined under Federal securities laws) based on current expectations and assumptions that involve risks and uncertainties. If the risks or uncertainties ever materialize or the assumptions prove incorrect, the results of BD may differ materially from those expressed or implied by such forward-looking statements and assumptions. Forward-looking statements may be identified by the use of words such as “plan,” “expect,” “believe,” “intend,” “will,” “may,” “anticipate,” “estimate” and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, future product development, regulatory approvals, competitive position and expenditures.

All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Many of these risks and uncertainties are beyond the company’s control. For a discussion of certain factors that could cause our actual results to differ from our expectations in any forward-looking statements see our latest Annual Report on Form 10-K and other filings with the SEC. BD expressly disclaims any undertaking to update or revise any forward looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable law or regulation.