NEW YORK — Techlab said last week that it has received European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for its C. Diff Quik Chek Complete test.
The test is a rapid membrane enzyme immunoassay designed for the simultaneous detection of Clostridioides difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well, providing results within 30 minutes.
According to Blacksburg, Virginia-based Techlab, which is part of Denmark's SSI Diagnostica, the test can help clinicians differentiate between active C. difficile infection and colonization.