Since the disease can rapidly become fulminant with serious concomitant complications such as intestinal obstruction, tissue disintegration, perforation and sepsis, and laboratory findings often take too long, many suspected cases are treated empirically. However, this approach is incorrect in many cases with suspected C. difficile infections (CDI). Studies have shown that rapid test results reduce the number of empiric therapies for suspected CDI and increase the treatment quality.1,2,3
Sofia 2 C. difficile FIA is a new CE-IVD approved test from Quidel. In accordance with the recommendation of the European Society for Clinical Microbiology and Infectious Diseases, it enables detection of C. difficile specific glutamate dehydrogenase (GDH) and disease-causing toxins in a single test (4 and Figure 1). The recommended detection of free toxins in stool is of particular prognostic relevance, as it is associated with a worse course of the disease.5,6 Furthermore, inclusion of free toxin testing, as recommended, avoids potential overdiagnosis of CDI. Overdiagnosis is especially likely when molecular testing is performed as the sole test, as it also provides a positive test result in pure carriers of the pathogen, even when no toxins are present in the stool and the diarrhoea is not caused by C. difficile.6
Source: Healthcare in Europe