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Journal of Clinical Microbiology, September 1999, p. 3044-3047, Vol. 37, No. 9
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Evaluation of Two Rapid Assays for Detection of Clostridium difficile Toxin A in Stool Specimens

Daniel P. Fedorko,1,* Howard D. Engler,1,dagger Elizabeth M. O'Shaughnessy,1 Esther C. Williams,1 Cynthia J. Reichelderfer,2 and William I. Smith Jr.2

Microbiology Service, Clinical Pathology Department, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892,1 and Department of Clinical Pathology, Suburban Hospital, Bethesda, Maryland 208142

Received 10 February 1999/Returned for modification 29 March 1999/Accepted 25 May 1999

Rapid laboratory diagnosis of Clostridium difficile-associated diarrhea (CDAD) is highly desirable in the setting of hospital cost containment. We tested 654 stool specimens to compare the performance of two assays for rapid detection of toxin A, the Immunocard Toxin A test (Meridian Diagnostics, Inc.) and the Culturette Brand Toxin CD enzyme immunoassay (EIA) (Becton Dickinson Microbiology Systems), with a cytotoxin assay (Cytotoxi Test; Advanced Clinical Diagnostics) and culture on cycloserine-cefoxitin-fructose agar followed by determination of the production of toxins A and B. A chart review was performed for patients whose stool specimens provided positive results on one to three of the assays. With the "gold standard" of all four assays positive or chart review evidence of CDAD, 97 (14.8%) stool specimens were positive by one or more assays and 557 (85.2%) were negative by all methods. Total agreement for all assays was 90.5% (592 of 654). The sensitivity, specificity, positive predictive value, and negative predictive value for toxigenic culture were 94.7, 98.6, 87.1, and 99.5%, respectively, for toxigenic culture; 87.7, 98.6, 86.2, and 98.8%, respectively, for the cytotoxin assay; 71.9, 99.3, 91.1, and 97.3%, respectively, for the Immunocard; and 68.4, 99.1, 88.6, and 96.9%, respectively, for the Culturette EIA. While easy to perform and highly specific, these rapid assays do not appear to be sufficient for accurate diagnosis of CDAD.

* Corresponding author. Mailing address: National Institutes of Health, Microbiology Service, CPD, Building 10, Room 2C385, 10 Center Dr. MSC 1508, Bethesda, MD 20892-1508. Phone: (301) 496-4433. Fax: (301) 402-1886. E-mail: dfedorko{at}nih.gov.

dagger Present address: MRL Reference Laboratory, Cypress, CA 90630.

Journal of Clinical Microbiology, September 1999, p. 3044-3047, Vol. 37, No. 9
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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