C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. In recent years, C. difficile infections have become more frequent, more severe and more difficult to treat, according to Mayo Clinic.
This test, the “ImmunoCard C. difficile GDH,” adds to a growing stable of C. difficile tests from Cincinnati-area Meridian Bioscience. The test detects an antigen called GDH that is produced by toxigenic and nontoxigenic strains of C. difficile, according to a statement from the company.
The new test is intended for use by laboratories to screen patients with diarrhea for C. diff.
Meridian received U.S. Food and Drug Administration clearance for another C. difficile test that detects the same antigen in May.
In March, the company received FDA clearance on what it called the only C. difficile test on the market aimed at patients younger than 2 years old.