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

Elizabeth J. Kvach, David Ferguson, Paul F. Riska, Marie L. Landry

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105 Citations (Scopus)

Abstract

The BD GeneOhm Cdiff assay, a real-time PCR assay for the detection of the Clostridium difficile toxin B (tcdB) gene, was compared with the toxin A/B (Tox A/B) II enzyme-linked immunosorbent assay (ELISA) and a two-step algorithm which includes a C. Diff Chek-60 glutamate dehydrogenase (GDH) antigen assay followed by cytotoxin neutralization. Four hundred liquid or semisolid stool samples submitted for diagnostic C. difficile testing, 200 GDH antigen positive and 200 GDH antigen negative, were selected for analysis. All samples were tested by the C. Diff Chek-60 GDH antigen and cytotoxin neutralization assays, the Tox A/B II ELISA, and the BD GeneOhm Cdiff assay. Specimens with discrepant results were tested by toxigenic culture as an independent "gold standard." Of 200 GDH-positive samples, 71 were positive by the Tox A/B II ELISA, 88 were positive by the two-step method, 93 were positive by PCR, and 96 were positive by the GDH antigen assay only. Of 200 GDH-negative samples, 3 were positive by PCR only. Toxigenic culture was performed for 41 samples with discrepant results, and 39 were culture positive. Culture resolution of discrepant results showed the Tox A/B II assay to have detected 70 (66.7%), the two-step method to have detected 87 (82.9%), and PCR to have detected 96 (91.4%) of 105 true positives. The BD GeneOhm Cdiff assay was more sensitive in detecting toxigenic C. difficile than the Tox A/B II assay (P < 0.0001); however, the difference between PCR and the two-step method was not significant (P < 0.1237). Enhanced sensitivity and rapid turnaround time make the BD GeneOhm Cdiff assay an important advance in the diagnosis of toxigenic C. difficile infection.

Original languageEnglish (US)
Pages (from-to)109-114
Number of pages6
JournalJournal of Clinical Microbiology
Volume48
Issue number1
DOIs
StatePublished - Jan 2010

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Clostridium Infections
Glutamate Dehydrogenase
Clostridium difficile
Real-Time Polymerase Chain Reaction
Enzyme-Linked Immunosorbent Assay
Antigens
Polymerase Chain Reaction
Cytotoxins

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

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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",
abstract = "The BD GeneOhm Cdiff assay, a real-time PCR assay for the detection of the Clostridium difficile toxin B (tcdB) gene, was compared with the toxin A/B (Tox A/B) II enzyme-linked immunosorbent assay (ELISA) and a two-step algorithm which includes a C. Diff Chek-60 glutamate dehydrogenase (GDH) antigen assay followed by cytotoxin neutralization. Four hundred liquid or semisolid stool samples submitted for diagnostic C. difficile testing, 200 GDH antigen positive and 200 GDH antigen negative, were selected for analysis. All samples were tested by the C. Diff Chek-60 GDH antigen and cytotoxin neutralization assays, the Tox A/B II ELISA, and the BD GeneOhm Cdiff assay. Specimens with discrepant results were tested by toxigenic culture as an independent {"}gold standard.{"} Of 200 GDH-positive samples, 71 were positive by the Tox A/B II ELISA, 88 were positive by the two-step method, 93 were positive by PCR, and 96 were positive by the GDH antigen assay only. Of 200 GDH-negative samples, 3 were positive by PCR only. Toxigenic culture was performed for 41 samples with discrepant results, and 39 were culture positive. Culture resolution of discrepant results showed the Tox A/B II assay to have detected 70 (66.7{\%}), the two-step method to have detected 87 (82.9{\%}), and PCR to have detected 96 (91.4{\%}) of 105 true positives. The BD GeneOhm Cdiff assay was more sensitive in detecting toxigenic C. difficile than the Tox A/B II assay (P < 0.0001); however, the difference between PCR and the two-step method was not significant (P < 0.1237). Enhanced sensitivity and rapid turnaround time make the BD GeneOhm Cdiff assay an important advance in the diagnosis of toxigenic C. difficile infection.",
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