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Journal of Clinical Microbiology, June 1998, p. 1608-1611, Vol. 36, No. 6
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Sensitivities and Specificities of Premier E. coli O157 and Premier EHEC Enzyme Immunoassays for Diagnosis of Infection with Verotoxin (Shiga-Like Toxin)-Producing Escherichia coli

A. M. R. Mackenzie,1,2,3,* P. Lebel,4 E. Orrbine,2,3 P. C. Rowe,2,5 L. Hyde,6 F. Chan,2 W. Johnson,6 P. N. McLaine,2,3 and The Synsorb Pk Study Investigatorsdagger

Division of Microbiology, Ottawa Civic Hospital,1 Canadian Pediatric Kidney Disease Research Centre, Children's Hospital of Eastern Ontario Research Institute,2 Department of Pediatrics, University of Ottawa,3 and Laboratory Centre for Disease Control,6 Ottawa, Ontario, and Hôpital Sainte-Justine, Montreal, Quebec,4 Canada, and Johns Hopkins University School of Medicine, Baltimore, Maryland5

Received 30 September 1997/Returned for modification 26 January 1998/Accepted 11 March 1998

This study describes the performance of two rapid enzyme immunoassays, Premier E. coli O157 and Premier EHEC (Meridian Diagnostics Inc., Cincinnati, Ohio) for the detection in stools of Escherichia coli O157 and verotoxins (Shiga-like toxins), respectively. Both tests were performed on stools from 876 children presenting to eight emergency departments with diarrhea. Standard culture, including E. coli O157:H7 isolation, was performed, and paired sera were taken for anti-O157-lipopolysaccharide antibody determination. Stools from patients enrolled in the study, and those yielding discordant results, were sent to a reference laboratory for repeat testing and further investigation, including cytotoxicity and non-O157 verotoxin-producing E. coli culture. Results were classified as field results (obtained in the eight site laboratories) and resolved results (obtained after repeat testing in the central laboratory). The "gold standard" for sensitivity of both tests and for specificity of Premier E. coli O157 was isolation of E. coli O157:H7 or a fourfold anti-O157 antibody rise. Specimens positive by the Premier EHEC test and negative for E. coli O157 culture were examined for non-O157 verotoxin-producing E. coli. The field sensitivity of Premier E. coli O157 was 86%, that of Premier EHEC was 89%, and the specificity of Premier E. coli O157 was 98%. Ten of 13 discordant Premier E. coli O157 results were reassigned as true results after repeat testing. Ten non-O157 verotoxin-producing E. coli isolates were recovered from Premier EHEC-positive, E. coli O157 culture-negative stools. Only one specimen gave an unequivocally false-positive Premier EHEC result. Both tests are highly sensitive and are specific if correctly performed. The Premier EHEC test will be particularly valuable as a practical routine test for the detection of non-O157 verotoxin-producing E. coli.

* Corresponding author. Mailing address: Ottawa Civic Hospital, Laboratory Medicine Bldg. M34, 1053 Carling Ave., Ottawa, Ontario K1Y 4E9, Canada. Phone: (613) 761-4359. Fax: (613) 761-5401. E-mail: amrmackenzie{at}civich.ottawa.on.ca.

dagger The SYNSORB Pk Study investigators are Scott Henwick and M. Peterson, Matsqui-Sumas-Abbotsford General Hospital, Abbotsford, British Columbia, Canada; Robert Rennie and Helen Tabor, University of Alberta Hospital, Edmonton, Alberta, Canada; Dierdre Church and Gary Katzko, Alberta Children's Hospital, Calgary, Alberta, Canada; Daryl Hoban, Health Sciences Centre, Winnipeg, Manitoba, Canada; Angela Quinlan, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada; Jane McDonald, Montreal Children's Hospital, Montreal, Quebec, Canada; Isabelle Savage, L'Hôpital Sainte-Justine, Montreal, Quebec, Canada; and Clifford Clark, Laboratory Centre for Disease Control, Ottawa, Ontario, Canada.

Journal of Clinical Microbiology, June 1998, p. 1608-1611, Vol. 36, No. 6
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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