Proof Source Key Points:

C. difficile
Evolution of Testing Algorithms at a University Hospital for the Detection of Clostridium
difficile Infections. Culbreath K et al; J Clin Microbiol epub 20 June 2012. From Peter Gilligans
laboratory at UNCH

Abstract
We present the evolution of testing algorithms at our institution in which the C. DIFF QUIK CHEK
COMPLETE immunochromatographic cartridge assay determines the presence of both glutamate
dehydrogenase and C. difficile toxins A and B as a primary screen for C. difficile infection and
indeterminant results (GDH positive/toxin A/B negative) are confirmed by the GeneXpert C. difficile
PCR assay. This two-step algorithm is a cost-effective method for highly sensitive detection of
toxigenic Clostridium difficile.

Key Points/Statements
This is the peer-reviewed published paper of the data Dr. Gilligan presented in his C. difficile
webinar. The conclusions are very similar to those presented in the webinar.

The Gilligan lab tested 4321 specimens over a 12 month period. Samples were tested on the
C. DIFF QUIK CHEK COMPLETE and GDH positives were confirmed by cytotoxicity testing
and PCR. This very large sample size greatly strengthens the conclusions drawn from the
study.

Operational impact: 87% of specimens were reported after performing the C. DIFF QUIK CHEK
COMPLETE. Samples needing confirmation were tested on-demand using the Cepheid
GeneXpert.

Strong economic impact: Using an algorithm of C. DIFF QUIK CHEK COMPLETE with
confirmation by Cepheid Xpert PCR saved the lab $89,244 annually compared to a PCR only
approach.

The Tox A/B portion of the C. DIFF QUIK CHEK COMPLETE had a positive predictive value
(PPV) of 90% in this study, confirming the 90 - 100% PPV seen in other studies. This means
toxin positive samples can be reliably reported with no further testing.

The lab expected to go 100% PCR after the study was completed, but the results were
unequivocal that algorithm testing provided the best patient care, with positive impacts to
laboratory workflow and cost savings.

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