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|
Primary Publication Information
|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.|
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)
|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|
|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|
|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%|
|Tests Compared||GeneOhm C. difficile (tcdB), Becton Dickinson Tox A/B II, Techlab|
|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%|
|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%|
Results & Comparisons
No Results found.