Evaluation of eight enzyme immunoassays for detection of immunoglobulin G against Helicobacter pylori.

Eight commercial enzyme-linked immunosorbent assays (ELISAs) were used to test sera taken from 102 patients in whom Helicobacter pylori infection status had been determined by means of biopsy culture, PCR, histology, and urease production and by 13C urea breath test. By those means, 61 patients had been found to be infected. Assays were compared by receiver operating characteristic analysis. Sensitivities ranged from 86 to 98%; specificities ranged from 83 to 98%. In a group consisting of the assays by Bio-Whittaker, Meddens Biotech, Orion (Pyloriset EIA G, new version), and Enteric Products, Inc. (HM Cap), differences in performance were not statistically significant. Sensitivities in this group ranged from 93 to 98%; specificities ranged from 95 to 98%. Assays from this group may be useful in addition to biopsy-based methods in diagnosing H. pylori infection.