Commercial PCR Assay For Diagnosis C. difficile Colitis

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Until recently, the only commercially available tests for diagnosis of Clostridium difficile-associated diarrhea were assays for the detection of toxins A and B. Although not FDA approved, there is now a commercially available kit to perform nested PCR for detection of toxin A and/or B genes in patient stool specimens. The only available performance data regarding this assay is in a published abstract from a recent national meeting. We purchased kits from the Korean manufacturer and have begun to evaluate the performance of the assay compared to the traditional C. difficile detection methods culture and an ELISA for toxins A and B. So far, this commercial assay compares well with the traditional methods. We will continue our comparison until we have tested 300 specimens by all methods. We have developed our own PCR assay for the detection of C. difficile toxin A and B genes and we plan on using this assay to resolve discrepant results. A chart review will be peformed to determine the clinical relevance of results generated by the commercial diagnostic PCR kit. To date there are no published articles describing the performance of this PCR kit.