title: Evaluation of the C.Diff Quik Chek Complete Assay, a new glutamate dehydrogenase and A/B toxin combination lateral flow assay for use in rapid, simple diagnosis of clostridium difficile disease.
abstract: The diagnosis of Clostridium difficile infection continues to be a challenge for many clinical microbiology laboratories. A new lateral flow assay, the C.Diff Quik Chek Complete assay, which tests for the presence of both glutamate dehydrogenase (GDH) and C. difficile toxins A and B, was evaluated for its ability to diagnose C. difficile disease. The results of this assay were compared to those of both PCR and toxigenic culture. The results showed that this assay allows 88% of specimens to be accurately screened as either positive (both tests positive) or negative (both tests negative) for the presence of toxigenic C. difficile in less than 30 min and with minimal hands-on time. Use of a random-access PCR for the analysis of specimens with discrepant results (one test positive and the other negative) allows the easy, rapid, and highly sensitive (100%; 95% confidence interval [CI], 89.6 to 100%) and specific (99.6%; 95% CI, 97.3 to 99.9%) diagnosis of C. difficile disease. The use of this algorithm would save institutional costs, curtail unnecessary isolation days, reduce the nosocomial transmission of disease, and increase the quality of care for patients.
authors.affiliation: Kaiser Permanente-NW, 13705 N.E. Airport Way, Portland, OR 97230, USA. susan.e.sharp@kp.org
authors.forename: Susan E
authors.initials: SE
authors.lastname: Sharp
authors.forename: Lila O
authors.initials: LO
authors.lastname: Ruden
authors.forename: Julie C
authors.initials: JC
authors.lastname: Pohl
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Hatcher
authors.forename: Linda M
authors.initials: LM
authors.lastname: Jayne
authors.forename: W Michael
authors.initials: WM
authors.lastname: Ivie
mesh_terms: D001426:Bacterial Proteins / Q000032:analysis*; D001427:Bacterial Toxins / Q000032:analysis*; D001431:Bacteriological Techniques / Q000379:methods*; D002623:Chemistry Techniques, Analytical; D016360:Clostridioides difficile / Q000201:enzymology*; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis* / Q000382:microbiology; D004768:Enterotoxins / Q000032:analysis*; D005969:Glutamate Dehydrogenase / Q000032:analysis*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile; D005969:Glutamate Dehydrogenase