FDA News

FDA approves new rapid C. diff test

Luminex announced that the FDA has cleared its Aries C. difficile assay for rapid detection of the infection.

The real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test detects both C. difficile toxins A and B, which could reduce false negatives from strains that only produce toxin A, according to a press release. It is part of the company’s gastroenterology testing menu that includes the xTAG Gastrointestinal Pathogen Panel, the Verigene Enteric Pathogens Test and the Aries Norovirus Assay CE-IVD.

C. difficile infections have become more frequent, severe and difficult to manage in recent years, increasing our need for better tools to diagnose and treat these debilitating and life-threatening infections,” Ray Widen, PhD, scientific director, esoteric testing and R&D at Tampa General Hospital, said in the press release. “This includes the ability to detect both toxin A and B genes of the bacterium. The Aries C. difficile Assay was easy to use and performed very well in our lab during the clinical trial. The combination of a simple workflow for ease of training, sample in/answer out capabilities for ease of use, rapid time to result, and flexible batch size, makes the Aries System a good fit for routine microbiology laboratories that may not have prior experience with molecular assays.”

The Aries System can run in multiple lab shifts and enables IVD and LDT assays to be run simultaneously in a sample to answer format when a universal assay protocol is used, according to the press release. Testing is entirely automated from sample preparation through analysis, and results take less than 2 hours “with minimal hands-on time while enabling easy implementation on weekends and night shifts.”

Disclosures: Widen was involved in a clinical trial of the assay, but Healio Gastroenterology was unable to confirm his relevant financial disclosures at the time of publication.

Luminex announced that the FDA has cleared its Aries C. difficile assay for rapid detection of the infection.

The real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test detects both C. difficile toxins A and B, which could reduce false negatives from strains that only produce toxin A, according to a press release. It is part of the company’s gastroenterology testing menu that includes the xTAG Gastrointestinal Pathogen Panel, the Verigene Enteric Pathogens Test and the Aries Norovirus Assay CE-IVD.

C. difficile infections have become more frequent, severe and difficult to manage in recent years, increasing our need for better tools to diagnose and treat these debilitating and life-threatening infections,” Ray Widen, PhD, scientific director, esoteric testing and R&D at Tampa General Hospital, said in the press release. “This includes the ability to detect both toxin A and B genes of the bacterium. The Aries C. difficile Assay was easy to use and performed very well in our lab during the clinical trial. The combination of a simple workflow for ease of training, sample in/answer out capabilities for ease of use, rapid time to result, and flexible batch size, makes the Aries System a good fit for routine microbiology laboratories that may not have prior experience with molecular assays.”

The Aries System can run in multiple lab shifts and enables IVD and LDT assays to be run simultaneously in a sample to answer format when a universal assay protocol is used, according to the press release. Testing is entirely automated from sample preparation through analysis, and results take less than 2 hours “with minimal hands-on time while enabling easy implementation on weekends and night shifts.”

Disclosures: Widen was involved in a clinical trial of the assay, but Healio Gastroenterology was unable to confirm his relevant financial disclosures at the time of publication.