R-Biopharm direct detection of C. difficile toxins A and B

Article No. N0803 is a simple, one-step rapid test based on lateral flow technology that enables direct detection of C. difficile toxins A and B in well homogenised stool samples in 15 minutes. The test kit contains all utensils needed for successful assay performance and allows users to make 25 individual determinations. A positive control, which is not provided with the kit, can be ordered separately under Art. No. NP0804.

Because the rapid test provides a quick diagnosis, transport-related decomposition of the toxins in the stool samples can be avoided and immediate patient management measures can be initiated as needed.

The first results of internal validation and comparison studies show that the sensitivity of the rapid test for C. difficile toxins A and B is good.

The rapid test is currently being investigated in a clinical comparison study where it will be compared to the cytotoxicity test (gold standard), culture and several competing immunological test products for detection of C. difficile toxins A and B. In addition to the obligatory detection of toxins A and B, the study will assess which test algorithm most reliably detects cases of C. difficile infection for which there is a clear causal relationship to the clinical picture.

A glutamate dehydrogenase antigen test and polymerase chain reaction tests for these toxigenic strains will round up the spectrum of testing methods to be investigated in the scope of this study.