Algorithm proposal based on the C. Diff Quik Chek Complete ICT device for detecting Clostridium difficile infection

Objective

To assess a new immunochromatography (ICT) test that detects glutamate dehydrogenase (GDH) antigen and Clostridium difficile toxin A/B simultaneously, and to propose an algorithm for the diagnosis of C. difficile infection (CDI) based on this test.

Methods

We analysed 970 stool samples. Discrepant results between GDH and toxin A/B were resolved using toxigenic culture as the reference.

Results

This test enabled us to obtain a conclusive result in <30 min in 93.8% of the samples. Among the discrepant results (GDH (+)/Toxin A/B (−)), 41.7% (25/60) were found to be toxigenic C. difficile by toxigenic culture.

Conclusion

This test has a high sensitivity and specificity for the diagnosis of CDI.