Healthcare-associated infection (HAI) - February 01, 2015

Evaluation of BD MAX™ Cdiff assay for toxigenic C.difficile detection

Evaluation of the BD MAX™ Cdiff assay for the detection of toxigenic Clostridium difficile in human stool specimens

Papanin Putsathit 1Justin MorganDamien BradfordNelly EngelhardtThomas V Riley

February 2015

Abstract: The Becton Dickinson (BD) PCR-based GeneOhm Cdiff assay has demonstrated a high sensitivity and specificity for detecting Clostridium difficile. Recently, the BD MAX™ platform, using the same principles as BD GeneOhm, has become available in Australia. This study aimed to investigate the sensitivity and specificity of BD MAX™ Cdiff assay for the detection of toxigenic C. difficile in an Australian setting. Between December 2013 and January 2014, 406 stool specimens from 349 patients were analysed with the BD MAX™ Cdiff assay.

Direct and enrichment toxigenic culture were performed on bioMérieux ChromID C. difficile agar as a reference method. isolates from specimens with discrepant results were further analysed with an in-house PCR to detect the presence of toxin genes.

The overall prevalence of toxigenic C. difficile was 7.2%. Concordance between the BD MAX™ assay and enrichment culture was 98.5%. The sensitivity, specificity, positive predictive value and negative predictive value for the BD MAX™ Cdiff assay were 95.5%, 99.0%, 87.5% and 99.7%, respectively, when compared to direct culture, and 91.7%, 99.0%, 88.0% and 99.4%, respectively, when compared to enrichment culture.

The new BD MAX™ Cdiff assay appeared to be an excellent platform for rapid and accurate detection of toxigenic C. difficile.

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.