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This study describes the performance of two rapid enzyme immunoassays, PremierE. coli O157 and Premier EHEC (Meridian Diagnostics Inc., Cincinnati, Ohio) for the detection in stools ofEscherichia 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, includingE. 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-producingE. 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 PremierE. coli O157 was isolation ofE. coli O157:H7 or a fourfold anti-O157 antibody rise. Specimens positive by the Premier EHEC test and negative forE. coli O157 culture were examined for non-O157 verotoxin-producingE. coli . The field sensitivity of PremierE. coli O157 was 86%, that of Premier EHEC was 89%, and the specificity of PremierE. coli O157 was 98%. Ten of 13 discordant PremierE. coli O157 results were reassigned as true results after repeat testing. Ten non-O157 verotoxin-producingE. 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-producingE. coli.

journal of clinical microbiology

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

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