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Journal of Clinical Microbiology, April 2003, p. 1480-1485, Vol. 41, No. 4
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.4.1480-1485.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Evaluation of the Effects of Strain-Specific Antigen Variation on the Accuracy of Serologic Diagnosis of Helicobacter pylori Infection

Patrice A. Marchildon,^1* Toshiro Sugiyama,² Yoshihiro Fukada,³ Jeffrey S. Peacock,¹ Masahiro Asaka,² Takashi Shimoyama,³ and David Y. Graham⁴

Enteric Products, Inc., Stony Brook, New York,¹ Department of Gastroenterology, Hokkaido University, Sapporo,² Department of Gastroenterology, Hyogo College of Medicine, Nishinomiya, Japan,³ Veterans Administration Medical Center and Baylor College of Medicine, Houston, Texas⁴

Received 25 September 2002/ Returned for modification 5 December 2002/ Accepted 14 January 2003

It has been suggested that enzyme immunoassay (EIA) kits validated in one region may yield variable diagnostic performance results in different regions, possibly due to strain-specific differences in antibody responses in different populations. We tested ¹³C-urea breath test-characterized serum samples from 109 U.S. patients and 288 Japanese patients using enzyme immunoassay with different preparations of high-molecular-weight cell-associated (HM-CAP) antigens that are conserved across Helicobacter pylori strains. Replicate antigens were prepared from five H. pylori clinical isolates. Eight antigen preparations were evaluated: two of U.S. origin and six of Japanese origin. The accuracies achieved with the eight antigen preparations ranged from 94.4 to 96.3% with the U.S. samples. With the Japanese samples the accuracies achieved ranged from 92.3 to 97.2%. Use of a pool of HM-CAP antigens prepared from isolates from Japan resulted in a higher median enzyme immunoassay value and slightly fewer samples with indeterminate results compared to the results obtained by use of the U.S. standard HM-CAP antigen for H. pylori-positive patients (accuracies, 97.2 and 92.3%, respectively), suggesting that variations in performance between both antigen source and patient population might be reduced by using antigens pooled from several strains.

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* Corresponding author. Mailing address: Enteric Products, Inc., 717 Main St., Westbury, NY 11590. Phone: (516) 333-8230. Fax: (516) 333-8278. E-mail: pmarchildon{at}ezem.com.

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Journal of Clinical Microbiology, April 2003, p. 1480-1485, Vol. 41, No. 4
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.4.1480-1485.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

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