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Clinical and Vaccine Immunology, March 2008, p. 575-578, Vol. 15, No. 3
1071-412X/08/$08.00+0     doi:10.1128/CVI.00282-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Comparison of the Premier Toxin A and B Assay and the TOX A/B II Assay for Diagnosis of Clostridium difficile Infection{triangledown}

Susan M. Novak-Weekley* and Michele H. Hollingsworth

Kaiser Permanente Regional Reference Laboratories, 11668 Sherman Way, North Hollywood, California 91605

Received 10 July 2007/ Returned for modification 20 September 2007/ Accepted 19 December 2007

Clostridium difficile causes nosocomial diarrhea and is responsible for complications such as pseudomembranous colitis, megacolon, and perforation. Using 442 stool specimens, we compared the sensitivities and specificities of the Premier toxin A and B (Meridian Bioscience, Inc.) and C. difficile TOX A/B II (TechLab, Inc., Blacksburg, VA) immunoassays in the Virology Department of the Kaiser Permanente Regional Reference Laboratories. The Premier toxin A and B assay demonstrated a higher sensitivity (97.44%) and a higher positive predictive value (79.17%) than the C. difficile TOX A/B II assay (87.18% and 75.56%, respectively), while assay specificities and negative predictive values were similar. We also performed experiments using serially diluted, purified toxin A and B antigens to understand the basis for assay differences. The two assays’ toxin A antibodies detected toxin A at comparable levels. Preliminary results indicated that the toxin B antibody in the Premier toxin A and B assay could detect toxin B at a concentration of 125 pg/100 µl, while the toxin B antibody in the C. difficile TOX A/B II assay could not detect toxin B below a concentration of 250 pg/100 µl. Therefore, the Premier toxin A and B assay provides greater sensitivity than the C. difficile TOX A/B II assay, perhaps due to a superior detection ability of its toxin B antibody.

* Corresponding author. Mailing address: Kaiser Permanente Regional Reference Laboratories, Virology Department, 11668 Sherman Way, North Hollywood, CA 91605. Phone: (818) 503-6884. Fax: (818) 503-6866. E-mail: Susan.M.Novak{at}kp.org

{triangledown} Published ahead of print on 2 January 2008.

Clinical and Vaccine Immunology, March 2008, p. 575-578, Vol. 15, No. 3
1071-412X/08/$08.00+0     doi:10.1128/CVI.00282-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



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