Serodiagnosis of Helicobacter pylori infection in Korean patients using enzyme-linked immunosorbent assay.

Helicobacter pylori (H. pylori) is a gram-negative spiral bacteria that are associated with gastritis, peptic ulcer and gastric cancer. We have developed enzyme-linked immunosorbent assay (ELISA) that detects serum anti-H. pylori immunoglobulin G antibodies using H. pylori strains isolated from Korean patients. To assess the sensitivity and specificity of our assay system with different commercial kits, serum samples from 249 Korean patients with a variety of gastrointestinal diseases were tested. Among 249 Korean patients, 178 (71.5%) were positive in culture and/or urease test. The sensitivity and specificity between our assay system and four other commercial kits (Bio-Rad, DAKO, ROCHE, and IPR) were as follows: 97.8% and 92%, 94.3% and 53%, 56.5% and 92%, 83.3% and 96%, 58.2% and 92%, respectively. All sera showing discordant immunoassay results between different ELISA kits were confirmed by immunoblot analysis. These results indicate that our assay system showed a highly accurate and reliable results in diagnosis of H. pylori infection in Korean patients.