Evaluation of the Xpert Clostridium diffcile assay for the diagnosis of Clostridium diffcile infection

Abstract

Infection with Clostridium diffcile is a growing concern because of the increasing prevalence and spread of nosocomial infections. Emergence of the hypervirulent 027/NAP1/BI strain is also notable. Existing diagnostic methods have low sensitivity or are time-consuming. Therefore, establishing a rapid and accurate microbiological diagnostic assay is needed. We evaluated the Xpert C. diffcile assay (Xpert CD assay; Cepheid, USA) to detect toxigenic C. diffcile. This assay is a real-time multiplex PCR assay that can be used to detect toxigenic C. diffcile strains and differentiate the C. diffcile presumptive 027/NAP1/BI strain. A total of 253 loose stool specimens were collected and toxigenic cultures, VIDAS C. diffcile A & B assays (VIDAS CDAB assay; bioMérieux, France), and the Xpert CD assay were performed. In comparison to toxigenic cultures, the sensitivity, specifcity, and positive and negative predictive values were 100%, 94.6%, 83.1%, and 100%, respectively, for the Xpert CD assay and 40.8%, 98.0%, 100%, and 88.9%, respectively, for VIDAS CDAB assay. Because of the low prevalence of the PCR ribotype 027 in Korea, the evaluation of the usefulness of the Xpert CD assay for screening for the 027 strain was limited. The Xpert CD assay provides great sensitivity in diagnosing toxigenic C. diffcile infection. In addition, this method has excellent usability because it is simple and fast. © The Korean Society for Laboratory Medicine.