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‘Ultra-sensitive’ C. difficile assay shows promise in pilot studies

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NEW ORLEANS — A new “ultra-sensitive” Clostridium difficile toxin A and B assay developed by Singulex showed “excellent sensitivity and precision” in small pilot studies, the results of which were presented at ASM Microbe.

The company developed the assay for use on the Sgx Clarity system, an automated in vitro diagnostics platform that uses clinically validated “Single Molecule Counting” technology, which provides the specificity of toxin tests and sensitivity “that rivals molecular methods,” according to a press release.

In the studies, the assay was able to detect C. difficile toxins A and B at 100 times lower concentrations than commercially available immunoassays, and test results took less than an hour.

An ultra-sensitive C. difficile toxin immunoassay “would be a game changer,” according to Christopher Polage, MD, associate professor of pathology and infectious diseases at the University of California, Davis School of Medicine.

“Our experience shows the importance of toxin testing to identify patients with C. difficile infection and minimize over-diagnosis but there’s still a lot of anxiety in the field,” he said in the press release. “Labs worry about missing individual CDI cases but hospitals are facing huge financial pressures to reduce CDI and blaming labs for using tests that don’t distinguish between infected and colonized patients. Having an ultra-sensitive toxin test would allow labs to give physicians a toxin result to help maximize the accuracy of CDI diagnosis without the worry of missing cases. This would improve patient care and allow hospitals to reduce CDI rates and avoid financial penalties, representing a ‘win–win’ for everyone.”

The platform is CE marked and available in Europe, and the company expects to receive FDA clearance in 2018, according to the press release.

Reference:

Chromy B, et al. Abstract 7044. Presented at: ASM Microbe; June 1-5, 2017; New Orleans.

Disclosures: Healio Gastroenterology was unable to confirm Polage’s relevant financial disclosures at the time of publication.