We are evaluating the performance of a PCR assay designed in our laboratory for the diagnosis of Clostridium difficile disease. This assay uses a primer set to detect the toxin A gene and another set to detect the toxin B gene. Endpoint detection of PCR products is an ELISA format. Our PCR assay will be compared to the following methods for diagnosis of C. difficile disease: toxigenic culture, cytotoxin assay, and an ELISA for detection of toxins A and B. DNA has been extracted from 443 stool specimens and the PCR assay has been performed on 292 of these specimens so far. Data from the other 3 assays is available for all 443 specimens. Once all PCR assays have been performed a chart review will be performed for specimens with conflicting results. Our results will demonstrate if PCR is a useful tool for diagnosis of C. difficile gastrointestinal disease.
