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.
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.
Doing
Kirk M
KM
Affiliated Laboratory, Inc., Bangor, ME 04401, USA. kdoing@ahs.emh.org
Hintz
Marilyn S
MS
Keefe
Calvin
C
Horne
Sarah
S
LeVasseur
Shelby
S
Kulikowski
Martha L
ML
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
D001426:Bacterial Proteins; D001427:Bacterial Toxins; D003603:Cytotoxins; D004768:Enterotoxins; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile; D005969:Glutamate Dehydrogenase