Department of Environmental and Preventive Medicine, Faculty of Medicine, Oita University, Yufu, Japan.
Department of Endoscopy, Cho Ray Hospital, Ho Chi Minh City, Vietnam.
J Gastroenterol Hepatol. 2021 Aug;36(8):2198-2209. doi: 10.1111/jgh.15467. Epub 2021 Mar 9.
To determine the application range of diagnostic kits utilizing anti-Helicobacter pylori antibody, we tested a newly developed latex aggregation turbidity assay (latex) and a conventional enzyme-linked immunosorbent assay (E-plate), both containing Japanese H. pylori protein lysates as antigens, using sera from seven Asian countries.
Serum samples (1797) were obtained, and standard H. pylori infection status and atrophy status were determined by culture and histology (immunohistochemistry) using gastric biopsy samples from the same individuals. The two tests (enzyme-linked immunosorbent assay and latex) were applied, and receiver operating characteristics analysis was performed.
Area under the curve (AUC) from the receiver operating characteristic of E-plate and latex curves were almost the same and the highest in Vietnam. The latex AUC was slightly lower than the E-plate AUC in other countries, and the difference became statistically significant in Myanmar and then Bangladesh as the lowest. To consider past infection cases, atrophy was additionally evaluated. Most of the AUCs decreased using this atrophy-evaluated status; however, the difference between the two kits was not significant in each country, but the latex AUC was better using all samples. Practical cut-off values were 3.0 U/mL in the E-test and 3.5 U/mL in the latex test, to avoid missing gastric cancer patients to the greatest extent possible.
The kits were applicable in all countries, but new kits using regional H. pylori strains are recommended for Myanmar and Bangladesh. Use of a cut-off value lower than the best cut-off value is essential for screening gastric cancer patients.
为了确定使用抗幽门螺杆菌抗体的诊断试剂盒的应用范围，我们使用来自七个亚洲国家的血清，对新开发的乳胶聚集浊度测定法（乳胶）和常规酶联免疫吸附测定法（E 板）进行了测试，这两种方法均使用日本幽门螺杆菌蛋白裂解物作为抗原。
收集血清样本（1797 份），并使用来自同一人群的胃活检样本通过培养和组织学（免疫组织化学）确定标准的幽门螺杆菌感染状态和萎缩状态。应用两种检测方法（酶联免疫吸附测定和乳胶），并进行受试者工作特征分析。
E 板和乳胶曲线的受试者工作特征分析的曲线下面积（AUC）几乎相同，越南的 AUC 最高。乳胶的 AUC 在其他国家略低于 E 板的 AUC，在缅甸和孟加拉国最低时差异具有统计学意义。为了考虑既往感染病例，还对萎缩进行了额外评估。使用这种萎缩评估状态后，大多数 AUC 降低；然而，在每个国家，两种试剂盒之间的差异均不显著，但使用所有样本时，乳胶的 AUC 更好。为了尽可能避免漏诊胃癌患者，E 测试的实用截止值为 3.0 U/mL，乳胶测试的实用截止值为 3.5 U/mL。
这些试剂盒在所有国家均适用，但对于缅甸和孟加拉国，建议使用使用地区幽门螺杆菌菌株的新试剂盒。为了筛选胃癌患者，使用低于最佳截止值的截止值是必要的。
