The detection of faecal cytotoxicity using tissue culture was compared with three commercial Clostridium difficile enzyme immunoassay (EIA) kits; Premier C difficile toxin A (Meridian Diagnostic, Inc.); CD-TOX C difficile toxin A (Porton Cambridge); and Cytoclone A+B EIA (Cambridge Biotech Corporation). Of 160 faecal samples examined by all four methods, 52 (32.5%) were cytotoxic, 44 (27.5%) were positive by Premier, 48 (30%) by CD-TOX EIA, and 50 (31.3%) with Cytoclone. When compared with detection of cytotoxicity by tissue culture assay, the following performance indices were obtained: Premier, sensitivity 84.1%, specificity 99.1%, positive predictive value (PPV) 97.8%, negative predictive value (NPV) 93%; CD-TOX, sensitivity 92.3%, specificity 88.0%, PPV 78.7%, NPV 95.9%; Cytoclone, sensitivity 96.2%, specificity 93.5%, PPV 87.7%, NPV 98.1%. EIA results were available within three hours, whereas the results of the cytotoxin assay were available after 24-48 hours. All three kits provided satisfactory results and, although relatively expensive, all could be used in the laboratory effectively to screen for diarrhoeal disease associated with C difficile.
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