title: Reevaluation of the Premier Clostridium difficile toxin A and B immunoassay with comparison to glutamate dehydrogenase common antigen testing evaluating Bartels cytotoxin and Prodesse ProGastro Cd polymerase chain reaction as confirmatory procedures.
abstract: Enzyme immunoassays are currently the most common tests used in the clinical laboratory for the detection of Clostridium difficile toxins; however, significant problems with their performance have recently been described. We prospectively reevaluated the Meridian Premier C. difficile toxin A/B assay with direct comparison to a 2-step algorithm that screened for C. difficile common antigen and compared cytotoxin and real-time polymerase chain reaction (PCR) as confirmatory procedures. The Premier assay lacked sufficient sensitivity, missing 25% of true-positive samples. PCR was the most sensitive method and the only procedure that allowed same day testing and reporting.
authors.affiliation: Affiliated Laboratory, Inc., Bangor, ME 04401, USA. kdoing@ahs.emh.org
authors.forename: Kirk M
authors.initials: KM
authors.lastname: Doing
authors.forename: Marilyn S
authors.initials: MS
authors.lastname: Hintz
authors.forename: Calvin
authors.initials: C
authors.lastname: Keefe
authors.forename: Sarah
authors.initials: S
authors.lastname: Horne
authors.forename: Shelby
authors.initials: S
authors.lastname: LeVasseur
authors.forename: Martha L
authors.initials: ML
authors.lastname: Kulikowski
mesh_terms: D001426:Bacterial Proteins / Q000032:analysis* / Q000235:genetics / Q000276:immunology / Q000633:toxicity; D001427:Bacterial Toxins / Q000032:analysis* / Q000235:genetics / Q000276:immunology / Q000633:toxicity; D016360:Clostridioides difficile / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000382:microbiology; D003092:Colitis / Q000382:microbiology; D003603:Cytotoxins / Q000633:toxicity*; D004768:Enterotoxins / Q000032:analysis* / Q000235:genetics / Q000276:immunology / Q000633:toxicity; D005969:Glutamate Dehydrogenase / Q000032:analysis* / Q000235:genetics / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D001426:Bacterial Proteins; D001427:Bacterial Toxins; D003603:Cytotoxins; D004768:Enterotoxins; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile; D005969:Glutamate Dehydrogenase