Automated Assay Detects C. difficile Including Hypervirulent Strains

A high-throughput, automated assay detects Clostridium difficile including the A-B+ 1470 variant, as well as the NAP1 strain.

The Intelligent Medical Devices, Inc. (IMDx; Cambridge, MA, USA) C. difficile assay for the Abbott (Abbott Park, IL, USA) m2000 is the first assay released under a multiyear distribution agreement between Abbott and IMDx whereby IMDx will design, develop, obtain regulatory clearances, and manufacture assays for the Abbott FDA-cleared m2000 instrument. The assay received the CE markimg for a high throughput automated C. difficile assay.

The C. difficile assay was designed for the Abbott m2000 using the IMDx bioinformatics process. It demonstrates a sensitivity of 95.7% and a specificity of 100%. "Our assays are developed to incorporate evolving clinical needs. Not only do we offer automated detection of toxigenic C. difficile genes, shortening the time needed to diagnose infections, but we also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470. Early identification of pathogens is critical in improving patient healthcare, shortening hospital stays, and reducing expenses," said Alice Jacobs, MD, chairman and CEO of IMDx.

C. difficile may develop after prolonged antibiotic use and is the most frequent cause of healthcare-associated diarrhea, also causing more severe intestinal conditions such as colitis. The bacterium is easily transmitted via direct contact with high-touch surfaces in patient rooms, contaminated patient-care items, and hands of health-care workers.

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