Method Description

Test is performed on the Cepheid GeneXpert Dx System, which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in simple or complex samples using real-time polymerase chain reaction (PCR) and reverse transcription PCR assays. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated.

The Cepheid Xpert C difficile/Epi Assay is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridioides (Clostridium) difficile from patients suspected of having C difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C difficile is by detection of binary toxin gene sequences and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C difficile toxin production.

The Xpert C difficile/Epi Assay is intended as an aid in the diagnosis of CDI. Detection of 027/NAP1/BI strains of C difficile by the Xpert C difficile/Epi Assay is presumptive and is solely for epidemiological purposes and is not intended to guide or monitor treatment for C difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.(Package insert: Xpert C difficile /Epi. Cepheid; Rev. J, 04/2020)