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

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7patients with antibiotic-associated diarrhea may range from 5 to 20%, and hospitals mayexperience rates lower or higher than this range. It is important to consider any testresults in conjunction with clinical symptoms because some healthy adults and largenumbers of healthy infants (up to 50%) will be positive for C. difficile toxin. In addition,C. difficile carriage rates of 22 to 32% have been reported in cystic fibrosis patients (1,3).Because the C. DIFF QUIK CHEK ® test detects both toxigenic and non-toxigenic strainsof C. difficile, the expected values of this test are higher compared to that of any toxintest. A positive result in the C. DIFF QUIK CHEK ® test confirms the presence ofC. difficile in a fecal specimen; a negative result indicates the absence of the organism.A positive result should be followed by a toxin-specific test to confirm the presence oftoxigenic C. difficile. The prevalence of a positive C. DIFF QUIK CHEK ® test at anindependent study site was 18.2% (N=578).PERFORMANCE CHARACTERISTICSClinical evaluationThe C. DIFF QUIK CHEK ® test was compared to the bacterial culture test at twoclinical laboratories and in-house at TECHLAB ® , Inc. Specimens included in theevaluation were submitted to the clinical laboratories for routine testing. The presumptivebacterial culture test was performed according to the in-house procedures. Theresults are shown in Table 1.Table 1.Summary of clinical performance comparing C. DIFF QUIK CHEK ® testto presumptive bacterial culturen=979C. DIFF QUIK CHEK ®positiveC. DIFF QUIK CHEK ®negativePresumptive BacterialCulture positivePresumptive BacterialCulture negative206 5616 70195% Confidence LimitsSensitivity 92.8% 88.3% - 95.7%Specificity 92.6% 90.4% - 94.3%Predictive Positive Value 78.6% 73.1% - 83.3%Predictive Negative Value 97.8% 96.3% - 98.7%FOR INFORMATIONAL USEONLYCorrelation 92.6% 91.7% - 93.4%Discrepant samples were resolved using commercial tests for C. difficile glutamatedehydrogenase in ELISA or membrane test formats, or by a research PCR assay for thedetection of C. difficile GDH gene gluD. Twenty-nine of the 56 apparent false positivesamples were positive by another GDH test, and were considered true positives.Twenty-seven remained false positive. Thirteen of the 16 apparent false negativesamples were negative by another GDH test, and were considered true negatives. Threeremained false negative.EFFECT OF FECAL SPECIMEN CONSISTENCYThe reaction of fecal specimens of varying consistencies in the C. DIFF QUIKCHEK ® test is shown in table 2. A total of 305 fecal samples of known consistency wasincluded in the analysis. The percentages of positive reactions using either resolvedculture assay or the C. DIFF QUIK CHEK ® test were similar in all three types of fecal
Page 1 and 2: C. DIFF QUIK CHEK ®A rapid test fo
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Page 13 and 14: 13Muestras formes/sólidas - Es pre
Page 15 and 16: 15LIMITACIONES1. El test C. DIFF QU
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Page 25 and 26: LEISTUNGSDATENKlinische Beurteilung
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Page 31 and 32: 31INTERPRÉTATION DES RÉSULTATS1.
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Page 35 and 36: 35INTERFÉRENCES ANALYTIQUESLes sub

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

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