C. DIFF QUIK CHEK multilingual 1-2009 pg1.pmd - TechLab

8specimens (liquid, semi-solid, and solid). All of the specimens were submitted forC. difficile testing. The basis of the submission was the clinical history of the patient andnot the consistency of the specimen. The results show the C. DIFF QUIK CHEK ® testperformed similarly to the culture assay when testing samples of different consistencies.Table 2.Reaction of fecal specimens of varying consistencies in theC. DIFF QUIK CHEK ® testLiquid Semi-solid SolidNumber of SpecimensSpecimens Specimens Specimens(n=305) (n = 117) (n = 142) (n = 46)Positive by resolvedbacterial culture assay19 (16.2%) 37 (26.1%) 18 (39.1%)Positive byC. DIFF QUIK CHEK ® 18 (15.4%) 36 (25.4%) 21 (45.7%)Negative by resolvedbacterial culture assay98 (83.8%) 105 (73.9%) 28 (60.9%)Negative byC. DIFF QUIK CHEK ® 99 (84.6%) 106 (74.6%) 25 (54.3%)TRANSPORT MEDIAA total of 69 fecal specimens diluted in C&S Transport Media was tested in theC. DIFF QUIK CHEK ® test and the results were compared to those obtained by routinetesting. The test exhibited an agreement of 95.7% for the detection of C. difficile antigenin specimens prepared in Transport Media.REPRODUCIBILITYA total of eight fecal specimens, 6 positive and 2 negative were coded to preventidentification and were sent to each of three independent laboratories for analysis usingthe C. DIFF QUIK CHEK ® test. The results from each laboratory were compared with inhouseresults. The positive specimens were confirmed to be positive and the negativespecimens were confirmed to be negative at each site.CROSS REACTIVITYFecal specimens inoculated with the following microorganisms to a final concentrationof approximately 10 8 or higher organisms per mL did not react in the C. DIFF QUIKCHEK ® test:FOR INFORMATIONAL USEONLYBacteria: Aeromonas hydrophila, Bacillus cereus, Bacillus subtilis, Bacteroides fragilis,Campylobacter coli, Campylobacter fetus, Campylobacter jejuni, Candida albicans,Clostridium bifermentans, Clostridium butyricum, Clostridium perfringens Type A,Clostridium septicum, Clostridium sordellii (toxigenic and nontoxigenic), Clostridiumsporogenes, Enterococcus faecalis, Escherichia coli EIEC, Escherichia coli, Escherichiacoli 0157 H7, Escherichia coli ETEC, Klebsiella pneumoniae, Peptostreptococcusanaerobius, Proteus vulgaris, Pseudomonas aeruginosa, Salmonella typhimurium,Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Staphylococcus aureus,Staphylococcus aureus (Cowans), Staphylococcus epidermidis, Vibrio parahaemolyticus,Yersinia enterocolitica