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Comparison of a frozen human foreskin fibroblast cell assay to an enzyme immunoassay and toxigenic culture for the detection of toxigenic Clostridium difficile |
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| Authors: | Alastair J. Strachan Natalie E. Evans O. Martin Williams Robert C. Spencer Rosemary Greenwood Chris J. Probert |
| Affiliation: | 1. Department of Clinical Sciences, University of Bristol, Bristol, UK;2. Health Protection Agency Microbiology Services, Bristol, Bristol, UK;3. Research Design Service–South West, University Hospital Bristol NHS Foundation Trust, Bristol, UK;4. Department of Gastroenterology, University of Liverpool, Liverpool, UK |
| Abstract: | This study set out to validate the Hs27 ReadyCell assay (RCCNA) as an alternative CCNA method compared against a commonly used commercial enzyme immunoassay (EIA) method and toxigenic culture (TC) reference standard. A total of 860 samples were identified from those submitted to the Health Protection Agency microbiology laboratories over a 30-week period. RCCNA performed much better than EIA when using TC as a gold standard, with sensitivities of 90.8% versus 78.6% and positive predictive value of 87.3% to 81.9%, respectively. The Hs27 Human Foreskin Fibroblast ReadyCells are an easy-to-use and a sensitive CCNA method for the detection of toxigenic Clostridium difficile directly from stool. A turnaround time of up to 48 h for a negative result and possible need for repeat testing make it an unsuitable method to be used in most clinical laboratory setting. |
| Keywords: | Clostridium difficile Enzyme immunoassay Toxigenic culture Cytotoxin |
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