The reference method influence on the sensitivity of the Clostridium difficile enzyme immunoassays: A meta analysis.

ABSTRACT

The use of enzyme immunoassays to screen for toxins A and B produced by Clostridium difficile is a common procedure in algorithms designed for its detection. Moreover, the absence of a unique test capable of providing reliable results at low cost motivates a great discussion about which algorithm is the best. Thus, several studies have evaluated the performance of these enzyme immunoassays. However, all fail to provide sufficient explanations for the different behaviours observed in different studies that evaluate the same index test against a common reference method. Our main goal was to find out which factors affect the sensitivity of these assays, since the specificity is very close to 1. In this research, we verified that sensitivity increases with the prevalence rate and with the proportion of reported cases of onset diarrhea. Therefore, its use is advisable for high prevalence rates (e.g. in an epidemic setting). As far as reference methods are concerned, nucleic acid amplification tests can be used as a reference method, with a performance similar to the well-accepted toxigenic culture. The method chosen for toxigenicity screening in a toxigenic culture also seems to affect the evaluation performance of tests and should be better studied in the future.