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Study Title and Description

Comparison of nine commercially available Clostridium difficile toxin detection assays, a real-time PCR assay for C. difficile tcdB, and a glutamate dehydrogenase detection assay to cytotoxin testing and cytotoxigenic culture methods.



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 nine commercially available Clostridium difficile toxin detection assays, a real-time PCR assay for C. difficile tcdB, and a glutamate dehydrogenase detection assay to cytotoxin testing and cytotoxigenic culture methods.
Author Eastwood K., Else P., Charlett A., Wilcox M.
Country Microbiology Department, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Year 2009
Numbers Pubmed ID: 19710274

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 Unknown n CDI suspected with some previously diagnosed CDI; Leeds Teaching Hospitals, London, UK Unknown spectrum Unknown selection
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Tested Specimens n=600 only 558 for GeneOhm test; fresh, unformed refrigerated except for GeneOHm that were frozen at -20 o C for < 8 months; Unknown blinded;
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Reference Standard/ % Positive in Sample CTA of specimen and cultured organisms when stool CTA was negative 20.8%
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Tests Compared GeneOhm C. difficile (tcdB), Becton Dickinson Premier Toxin A&B, Meridian Premier ImmunoCard Toxins A&B, Meridian Tox A/B II, Techlab Tox A/B Quik Chek, Techlab ProSpecT Toxin A/B, Remel Xpect Toxin A/B, Remel VIDAS C. difficile Tox A/B
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PPV/ NPV GeneOhm C. difficile (tcdB), Becton Dickinson PPV 92/108=85.2% NPV 433/444=97.5% Premier Toxin A&B, Meridian PPV 101/113=89.4% NPV 463/487=95.1% Premier ImmunoCard Toxins A&B, Meridian PPV 86/88=97.7% NPV 442/471=93.8% Tox A/B II, Techlab PPV 100/119=84.0% NPV 456/481=94.8% Tox A/B Quik Chek, Techlab PPV 93/96=96.9% NPV 470/502=93.6% ProSpecT Toxin A/B, Remel PPV 102/134=76.1% NPV 443/466=92.9% Xpect Toxin A/B, Remel PPV 86/89=96.6% NPV 472/503=93.8% VIDAS C. difficile Tox A/B PPV 100/102=98.0% NPV 462/478=96.6%
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True Positive/ False Positive‡ GeneOhm C. difficile (tcdB), Becton Dickinson True Positive 92/103=89.3% False Positive 16/449=3.6% Premier Toxin A&B, Meridian True Positive 101/125=80.8% False Positive 12/475=2.5% Premier ImmunoCard Toxins A&B, Meridian True Positive 86/115=74.8% False Positive 2/444=0.4% Tox A/B II, Techlab True Positive 100/125=80.0% False Positive 19/475=4.0% Tox A/B Quik Chek, Techlab True Positive 93/125=74.4% False Positive 3/473=0.6% ProSpecT Toxin A/B, Remel True Positive 102/125=81.6% False Positive 32/475=6.7% Xpect Toxin A/B, Remel True Positive 86/117=73.5% False Positive 3/475=0.6% VIDAS C. difficile Tox A/B True Positive 100/116=86.2% False Positive 2/464=0.4%
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Results & Comparisons

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