Description
A rapid test for the identification of toxigenic Clostridium difficile bacteria
The VERIGENE® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence 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 test is performed on the VERIGENE System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test 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.
C. difficile infections (CDI) cause symptoms that range from mild diarrhea to the more severe and potentially fatal pseudomembranous colitis. Further complicating CDI is the emergence of PCR ribotype 027 hypervirulent strain, the epidemic strain of C. difficile, believed to be the cause of the increase in occurrence and severity of CDI since 2000.
Accurate diagnosis of CDI is essential to ensure patients receive appropriate treatment, and that correct infection control measures are put in place. However, the current standard of care tests for diagnosis of CDI lack the accuracy necessary for optimal patient management of those with suspected CDI.
The automated VERIGENE System is uniquely suited to deliver an easy to use, cost-effective solution for rapid identification of toxin-producing C. difficile and differentiation of the PCR ribotype 027 strain, allowing for improved infection control and reporting of the epidemic strain.
Clostridium difficile Test Specifications:
Toxin A (tcdA gene)
Toxin B (tcdB gene)
PCR Ribotype 027 hypervirulent strain (For epidemiologic purposes only)
Features:
Automation: Sample-to-result
Instrumentation: VERIGENE® Reader and Processor SP
Workflow: On-demand and scalable
Sample Type: Stool
Pipetting Steps: One
Hands-On Time: <5 minutes
Run Time: <2 hours
