cobas® Cdiff Test

For use on the cobas® 4800 System
IVD For in vitro diagnostic use.
Answers that help stop the threat of infection

Traditional methods for identification of Clostridioides difficile (C.difficile) include toxigenic culture, which is labor intensive and slow, and enzyme immunoassays (EIA), which have limited sensitivity. Algorithms have been developed using combinations of EIA testing to overcome shortcomings of individual assays.1 However, these algorithms may introduce delays in reporting results to physicians, which adversely impacts patient management.

Molecular technologies (including nucleic acid amplification tests [NAAT]) offer better sensitivity and turnaround time in identifying toxigenic C. difficile when compared to several other approaches (glutamate dehydrogenase [GDH] assay, toxin A and B immunoassay, cell culture cytotoxicity neutralization assay), either alone or in combination.1

In recent years, the frequency and severity of C. difficile-associated disease has continued to increase, prompting a need for rapid and reliable C. difficile testing, particularly in vulnerable elderly populations. By rapidly detecting C. difficile in patient stool samples, the cobas® Cdiff Test on the cobas® 4800 System combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from C. difficile-associated disease.

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References:

  1. Surawicz et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98.
  2. cobas® Cdiff Test [package insert]. Indianapolis, IN: Roche Diagnostics; 2019.
  3. Argent Microbiology Workflow Study 2014. Roche data on file.