Diagnostic accuracy of serological kits for Helicobacter pylori infection with the same assay system but different antigens in a Japanese patient population.

Helicobacter pylori infection is thought to be a causal risk factor for gastric carcinoma. Recently, diagnostic accuracy of serological kits for H. pylori infection that were made in Western countries has been reported to be lower when used among Oriental populations. Diagnostic accuracy of two serological kits [HM-CAP and HM-CAP with antigens extracted from clinically isolated Japanese H. pylori strains (J-HM-CAP)] was investigated in 440 samples from a Japanese patient population by using the (13)C-urea breath test as gold standard. According to the original optimal cut-off value, HM-CAP provided 87.5 % sensitivity and 84.8 % specificity with 86.8 % accuracy and J-HM-CAP provided 95.5 % sensitivity and 81.9 % specificity with 92.3 % accuracy. This study suggests that antigens from HM-CAP are satisfactory for examining a Japanese patient population, but that using local antigens improves accuracy.