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目的：寻求敏感性高、特异性强的ＨＰ抗原和简便、可靠的检测ＨＰ抗体的方法，用于诊断ＨＰ感染。方法：分别以ＨＰ尿素酶、全菌破碎物、培养上清液为抗原。采用斑点金标免疫渗滤法（ＤＩＧＦＡ）检测ＨＰ培养、病理组织学检查、尿素酶试验均阳性和均阴性的血清各５０份；胃镜检查各类胃病患者血清２５８份，并以ＥＬＩＳＡ试剂盒做平行检测对照。结果：三种抗原的敏感性分别为１００％、９６％和７６％；５０份阴性血清的阴性符合率分别为９８％、９２％和６４％；２５８份各类胃病的抗体检出率分别为６１％、６２％和５２％；与ＥＬＩＳＡ符合率各为９８８％、９６５％和５８９％。将抗原浓度稀释至００５ｍｇ／ｍｌ时，尿素酶抗原和全菌破碎物抗原的特异性抗体检出率仍达８５％和７５％。培养上清液抗原的敏感性和特异性明显低于前二种抗原（Ｐ＜００１）。尿素酶抗原和全菌破碎抗原的敏感性和特异性明显低于前二种抗原（Ｐ＞００５）。结论：提示该全菌破碎物抗原用于ＤＩＧＦＡ检测ＨＰ抗体、敏感性高、特异性强，且简便、快速、无需任何仪器设备。适合于临床和流行病学调查应用。
OBJECTIVE: To search for HP antigen with high sensitivity and specificity and simple and reliable method to detect HP antibody, which is used to diagnose HP infection. Methods: Respectively with HP urease, whole bacteria disrupted, culture supernatant as antigen. Fifty serum samples of HP culture, histopathological examination and urease test were positive and negative, respectively. Fifty-eight serum samples were obtained from gastroscopy patients with various types of gastric diseases. ELISA kit was used Parallel test control. Results: The sensitivity of the three antigens were 100%, 96% and 76%, respectively. The negative coincidence rates of the 50 negative sera were 98%, 92% and 64% respectively. The detection rates of the antibodies against 258 kinds of stomach diseases were 61%, 62% and 52%, respectively. The coincidence rates with ELISA were 988%, 965% and 589%, respectively. When the antigen concentration was diluted to 0 05mg / ml, the specific antibody detection rate of urease antigen and whole-cell disrupted antigen was still 85% and 75%. The sensitivity and specificity of culture supernatant antigens were significantly lower than the former two antigens (P <001). The sensitivity and specificity of urease antigen and whole-cell antigen were significantly lower than those of the first two antigens (P> 0.05). Conclusion: It is suggested that the whole bacterial debris antigen is used to detect HP antibody by DIGFA. It has high sensitivity, specificity and is simple, rapid and requires no equipment. Suitable for clinical and epidemiological investigations.