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This study evaluated the sensitivity of serological and direct methods for the diagnosis of Helicobacter pylori infection in 127 patients with gastric carcinoma and in 127 controls without this disease, matched for age and sex. Antral and oxyntic mucosal specimens were obtained from all patients, at operation in patients with gastric carcinoma and at endoscopy from controls. The urease test, microscopy of stained smears and culture for H. pylori were performed on all specimens. Sera from all patients were tested for antibodies to H. pylori by a highly sensitive and specific IgG-ELISA. Culture, urease test, stained smear and ELISA were significantly less sensitive in the patients with gastric carcinoma than in control subjects. However, the combination of several methods improved the diagnosis of H. pylori infection in the gastric carcinoma group. Infection was significantly more frequent in the gastric carcinoma patients than in the controls. H. pylori infection was associated with an increased risk of developing gastric carcinoma.