Evaluation of three commercial enzyme-linked immunosorbent assay kits for diagnosis of Helicobacter pylori in Chinese patients

Most of the commercial serological assays for H. pylori nle developed and validated in western countries. We evaluated the accuracy of three popular commercial ELISA tests for H. pylori in the Chinese population. Eighty dyspeptic patients were recruited and diagnosis of H. pylori infection was based on biopsy urease lest, histology and urea breath test. Thirty-six patients (45%) were positive for H. pylori infection by two ol more positive reference tests. Anti-H. pylori IgG antibody was detected by three commercial ELISA tests: GAP Ige (Bio-Rad), HM-CAP (Enteric Products) and Pyloriset EIA-G (Orion). The respective sensitivity, specificity, positive and negative predictive values of the three tests were: GAP IgG (50%, 97.4%, 93.8%, 71.7%), HM-CAP (72.7%, 68.4%, 66.7%, 74.3%) and Pyloriset EIA-G (75%, 86.4%, 81.8%, 80.9%). Despite the high accuracy reported in the West, the performance of these commercial serological tests rc,iis unsatisfactory when used in Chinese patients. (C) 1999 Elsevier Science Inc.