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Study Title and Description

Comparison of BD GeneOhm Cdiff real-time PCR assay with a two-step algorithm and a toxin A/B enzyme-linked immunosorbent assay for diagnosis of toxigenic 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 BD GeneOhm Cdiff real-time PCR assay with a two-step algorithm and a toxin A/B enzyme-linked immunosorbent assay for diagnosis of toxigenic Clostridium difficile infection.
Author Kvach EJ., Ferguson D., Riska PF., Landry ML.
Country Department of Laboratory Medicine, Yale University School of Medicine, New Haven, CT 06520-8035, USA.
Year 2010
Numbers Pubmed ID: 19864479

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=341 in hospital with suspected CDI; Yale-New Haven Hospital, CT Unknown spectrum Unknown selection
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Tested Specimens n=400 fresh liquid or semisolid that were either GDH positive or negative; Some frozen at -20o C for < week after two-step GDH/CTA to do other tests; Excluded if patient being treated for CDI or retested within 7 days; Unknown blinded
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Reference Standard/ % Positive in Sample If not all positive or negative on 3 tests, then toxigenic culture using Premier Toxin A/B test of cultured organisms 26.2%
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Tests Compared GeneOhm C. difficile (tcdB), Becton Dickinson Tox A/B II, Techlab
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PPV/ NPV GeneOhm C. difficile (tcdB), Becton Dickinson PPV 96/96=100% NPV 295/304=97.0% Tox A/B II, Techlab PPV 70/71=98.6% NPV 294/329=89.4%
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True Positive/ False Positive‡ GeneOhm C. difficile (tcdB), Becton Dickinson True Positive 96/105=91.4% False Positive 0/295=0% Tox A/B II, Techlab True Positive 70/105=66.7% False Positive 1/295=0.3%
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Results & Comparisons

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