A novel diagnostic monoclonal antibody specific for Helicobacter pylori CagA of East Asian type.

我们开发并验证了酶联免疫吸附试验（ELISA）使用的单克隆抗体特异性识别东亚CagA阳性H。幽门。共32个H。pylori菌株进行检测，并对数据进行受试者工作特征（ROC）曲线分析。通过计算曲线下面积确定的试验准确度为0.96，表明准确度较高。在ROC最佳临界值下，ELISA方法的敏感性和特异性分别为88.0%和100%。经验证的ELISA在灵敏度和特异性方面表现出良好的性能。这些结果表明，该试验适用于东亚CagA携带菌株的诊断检测。我们还分析了CagA蛋白在H. pylori感染胃粘膜后，通过荧光免疫组化观察，发现CagA蛋白的表达通过与上皮细胞的粘附而上调。

We developed and validated an enzyme linked immunosorbent assay (ELISA) using a monoclonal antibody specifically recognizing East Asian CagA positive H. pylori. A total of 32 H. pylori strains were tested and the data were subjected to receiver operator characteristic (ROC) curve analysis. The accuracy of the test, determined by calculating the area under the curve, was 0.96, which indicated a high level of accuracy. At the ROC optimized cut off, the sensitivity and specificity of our ELISA method were 88.0% and 100%, respectively. The validated ELISA showed good performance in terms of sensitivity and specificity. These results suggest that this test is suitable for the diagnostic detection of East Asian CagA carrying strains. We also analyzed the localization of the CagA protein in H. pylori infected gastric mucosa with fluorescence immunohistochemistry, and found that CagA protein expression was up regulated by adhesion to epithelial cells.