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Study Title and Description

Comparison of real-time PCR for detection of the tcdC gene with four toxin immunoassays and culture in diagnosis of Clostridium difficile infection.



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 Comparison of real-time PCR for detection of the tcdC gene with four toxin immunoassays and culture in diagnosis of Clostridium difficile infection.
Author Sloan LM., Duresko BJ., Gustafson DR., Rosenblatt JE.
Country Division of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota 55906, USA.
Year 2008
Numbers Pubmed ID: 18434563

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=200 suspected CDI; Mayo Clinic, Rochester, MN Unknown spectrum Unknown selection
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Tested Specimens n=200 soft or liquid; fresh or frozen < 48 hrs. Unknown blinded; Unknown indeterminate results
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Reference Standard/ % Positive in Sample Toxigenic culture using toxin A and B gene detection for cultured organisms 22.0%
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Tests Compared Premier Toxin A&B, Meridian ImmunoCard Toxin A&B, Meridian Xpect C. diff. toxin A/B, Remel
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PPV/ NPV Premier Toxin A&B, Meridian PPV 21/24=87.5% NPV 153/176=86.9% ImmunoCard Toxin A&B, Meridian PPV 21/23=91.3% NPV 154/177=87.0% Xpect C. diff. toxin A/B, Remel PPV 21/46=45.6% NPV 131/154=85.1%
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True Positive/ False Positive‡ Premier Toxin A&B, Meridian True Positive 21/44=47.7% False Positive 3/156=1.9% ImmunoCard Toxin A&B, Meridian True Positive 21/44=47.7% False Positive 2/156=1.3% Xpect C. diff. toxin A/B, Remel True Positive 21/44=47.7% False Positive 25/156=16.0%
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Results & Comparisons

No Results found.