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Study Title and Description

Six rapid tests for direct detection of Clostridium difficile and its toxins in fecal samples compared with the fibroblast cytotoxicity assay.



Key Questions Addressed
1 Key Question 1 - Summary of matched comparisons of select assays for C. difficile toxins
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Primary Publication Information
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TitleData
Title Six rapid tests for direct detection of Clostridium difficile and its toxins in fecal samples compared with the fibroblast cytotoxicity assay.
Author Turgeon DK., Novicki TJ., Quick J., Carlson L., Miller P., Ulness B., Cent A., Ashley R., Larson A., Coyle M., Limaye AP., Cookson BT., Fritsche TR.
Country Department of Laboratory Medicine, School of Medicine, University of Washington, Seattle, Washington 98195-7110, USA.
Year 2003
Numbers Pubmed ID: 12574264

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 1 - Summary of matched comparisons of select assays for C. difficult toxins (Table C1)
Design Details
Question... Follow Up Answer Follow-up Answer
Patients/ Site n=1003 Consecutive samples, all suspected CDI; Childrens, university & cancer centers in Seattle, WA; 45% stem cell transplant patients Unknown spectrum Unknown selection
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Tested Specimens n=1003 any consistency; fresh for CTA, rest frozen at -20o C; Unknown interim time Unknown blinded Unknown indeterminate results
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Reference Standard/ % Positive in Sample CTA 10.1%
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Tests Compared Premier Cytoclone A/B, Meridian C. diff Tox A/B, Techlab
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PPV/ NPV Premier Cytoclone A/B, Meridian PPV 74/82=90.2% NPV 890/917=97.1% C. diff Tox A/B, Techlab PPV 78/83=94.0% NPV 897/902=99.4%
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True Positive/ False Positive‡ Premier Cytoclone A/B, Meridian True Positive 74/101=73.3% False Positive 8/898=0.9% C. diff Tox A/B, Techlab True Positive 78/101=77.2% False Positive 5/902=0.6%
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Results & Comparisons

No Results found.