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Study Title and Description

Clostridium difficile testing in the clinical laboratory by use of multiple testing algorithms.



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 Clostridium difficile testing in the clinical laboratory by use of multiple testing algorithms.
Author Novak-Weekley SM., Marlowe EM., Miller JM., Cumpio J., Nomura JH., Vance PH., Weissfeld A.
Country Southern California Permanente Medical Group, North Hollywood, California 91605, USA. Susan.M.Novak@kp.org
Year 2010
Numbers Pubmed ID: 20071552

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 = 432 suspected CDI; patients under 2 years old excluded; Southern CA Permanente Medical Labs; Unknown spectrum Unknown selection
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Tested Specimens n = 432 Unknown fresh Unformed, refrigerated; Unknown blinded;
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Reference Standard/ % Positive in Sample Toxigenic culture using CTA on cultured organisms 16.7%
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Tests Compared GeneXpert C.difficile (tcdB), Cepheid Premier Toxins A&B, Meridian 1st C. difficle CHEK- 60 (GDH), Techlab; if positive, then Premier Toxins A&B
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PPV/ NPV GeneXpert C.difficile (tcdB), Cepheid PPV 68/81=84.0% NPV 343/347=98.8% Premier Toxins A&B, Meridian PPV 42/61=68.9% NPV 341/371=91.9% 1st C. difficle CHEK-60 (GDH), Techlab; if positive, then Premier Toxins A&B PPV 40/46=87.0% NPV 354/386=91.7%
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True Positive/ False Positive‡ GeneXpert C.difficile (tcdB), Cepheid True Positive 68/72=94.4% False Positive 13/356=3.7% Premier Toxins A&B, Meridian True Positive 42/72=58.3% False Positive 19/360=5.3% 1st C. difficle CHEK-60 (GDH), Techlab; if positive, then Premier Toxins A&B True Positive 40/72=55.6% False Positive 6/360=1.7%
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Results & Comparisons

No Results found.