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Study Title and Description

Detection of Clostridium difficile toxin: comparison of enzyme immunoassay results with results obtained by 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 Detection of Clostridium difficile toxin: comparison of enzyme immunoassay results with results obtained by cytotoxicity assay.
Author Musher DM., Manhas A., Jain P., Nuila F., Waqar A., Logan N., Marino B., Graviss EA.
Country Medical Service (Infectious Disease Section), Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, USA. daniel.musher@med.va.gov
Year 2007
Numbers Pubmed ID: 17567791

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 inpatients suspected CDI; Michael E. DeBakey VA Medical Center, Houston, TX Unknown spectrum Unknown selection
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Tested Specimens n=446 Unknown fresh Unknown consistency Unknown blinded Unknown indeterminate results Part 2 n=131 Convenience sample; Fresh; Unknown consistency Unknown blinded Unknown indeterminate results
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Reference Standard/ % Positive in Sample CTA 17.0% CTA 41.2%
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Tests Compared Premier Toxin A&B, Meridian ImmunoCard Toxin A & B, Meridian Premier Toxin A&B, Meridian C. difficile TOX A/B II, TechLab ProSpecT Clostridium difficile toxin A/B, Remel
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PPV/ NPV Premier Toxin A&B, Meridian PPV 75/85=88.2% NPV 360/361=99.7% ImmunoCard Toxin A & B, Meridian PPV 73/77=94.8% NPV 366/369=99.2% …………………. Premier Toxin A&B, Meridian PPV 52/57=91.2% NPV 72/74=97.3% C. difficile TOX A/B II, TechLab PPV 52/62=83.9% NPV 67/69=97.1% ProSpecT Clostridium difficile toxin A/B, Remel PPV 49/51=96.1% NPV 75/80=93.8%
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True Positive/ False Positive‡ Premier Toxin A&B, Meridian True Positive 75/76=98.7% False Positive 10/370=2.7% ImmunoCard Toxin A & B, Meridian True Positive 73/76=96.1% False Positive 4/370=1.1% ………………….. Premier Toxin A&B, Meridian True Positive 52/54=96.3% False Positive 5/77=6.5% C. difficile TOX A/B II, TechLab True Positive 52/54=96.3% False Positive 10/77=13.0% ProSpecT Clostridium difficile toxin A/B, Remel True Positive 49/54=90.7% False Positive 2/77=2.6%
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Results & Comparisons

No Results found.