title: Comparison of a frozen human foreskin fibroblast cell assay to an enzyme immunoassay and toxigenic culture for the detection of toxigenic Clostridium difficile.
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.
authors.affiliation: Department of Clinical Sciences, University of Bristol, Bristol, UK. ally.strachan@bristol.ac.uk
authors.forename: Alastair J
authors.initials: AJ
authors.lastname: Strachan
authors.forename: Natalie E
authors.initials: NE
authors.lastname: Evans
authors.forename: O Martin
authors.initials: OM
authors.lastname: Williams
authors.forename: Robert C
authors.initials: RC
authors.lastname: Spencer
authors.forename: Rosemary
authors.initials: R
authors.lastname: Greenwood
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Probert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001427:Bacterial Toxins / Q000032:analysis* / Q000633:toxicity*; D018929:Cell Culture Techniques / Q000379:methods; D016360:Clostridioides difficile / Q000302:isolation & purification* / Q000472:pathogenicity; D003015:Clostridium Infections / Q000175:diagnosis* / Q000382:microbiology; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D001427:Bacterial Toxins