Diagnostic Microbiology & Infectious Disease
Volume 66, Issue 2 , Pages 129-134, February 2010

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☆

  • Kirk M. Doing

      Affiliations

    • Affiliated Laboratory, Inc., Bangor, ME 04401, USA
    • Department of Biology and Ecology, University of Maine, Orono, ME 04469, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1-207-973-6900; fax: +1-207-973-6999.
    • ,
  • Marilyn S. Hintz

      Affiliations

    • Affiliated Laboratory, Inc., Bangor, ME 04401, USA
    • ,
  • Calvin Keefe

      Affiliations

    • Affiliated Laboratory, Inc., Bangor, ME 04401, USA
    • ,
  • Sarah Horne

      Affiliations

    • Department of Biology and Ecology, University of Maine, Orono, ME 04469, USA
    • ,
  • Shelby LeVasseur

      Affiliations

    • Department of Biology and Ecology, University of Maine, Orono, ME 04469, USA
    • ,
  • Martha L. Kulikowski

      Affiliations

    • Affiliated Laboratory, Inc., Bangor, ME 04401, USA

Received 17 July 2009; accepted 2 September 2009.

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.

Keywords: Clostridium difficile, Toxin

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☆ Work performed at Affiliated Laboratory.

PII: S0732-8893(09)00364-2

doi:10.1016/j.diagmicrobio.2009.09.001

Diagnostic Microbiology & Infectious Disease
Volume 66, Issue 2 , Pages 129-134, February 2010

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