【摘要】  目的  探讨粪便幽门螺杆菌（Hp）特异性抗原（HpSA）在诊断Hp感染中的价值。方法  371例因上消化道症状就诊于我院消化内科的患者均采用酶免疫分析(EIA)法检测HpSA，以病理组织学或13C-尿素呼气试验（13C-UBT）作为诊断 Hp 感染的“金标准”，应用ROCKIT for windows1.1β和SPSS 15.0进行统计学分析，应用不拘分布形式参数法（拟合双正态模型）和非参数法绘制光滑受试者操作特征分析曲线（ROC curve）和经验 ROC 曲线，以曲线下面积（Az）评价HpSA试验的诊断价值。结果χ2检验表明EIA法检测Hp感染与“金标准”比较差异无统计学意义（P >0.05）；EIA法检测HpSA敏感度89.2%，特异度96%，Youden指数0.85，Kappa值0.86；EIA法检测HpSA的不拘分布形式参数法和非参数法ROC曲线下面积分别为0.95和0.93，与完全无诊断价值的机会线下面积0.50相比差异均有显著性统计学意义（P <0.001）。结论  HpSA（单克隆抗体包被是一种非侵入性诊断Hp感染的方法，该法简便易行，值得临床进一步推广。

【Abstract】 Objective To evaluate diagnosis value of the detection of Helicobacter pylori (Hp ) specific antigen (HpSA) in the stool samples for the diagnosis of Hp infection. Methods HpSA specimens were detected by enzyme immunoassay (EIA) in 371 cases, the evaluation of Hp infection status was defined as positive when pathohistology or 13C-urea breath test (13C-UBT) was positive, ROCKIT for windows 1.1 β software and SPSS 15.0 software package were used to analyze the datum. Parametric distribution-free approach (PDF) and non -parametric method were used to drawn the relative operating characteristic (ROC) curve. Using the area under the ROC curve (Az ) to evaluate significance of the detection of HpSA in the diagnosis of HP infection. Results The chi -square test showed that there was not significant difference between diagnosis of Hp infection by EIA and by the gold standard (P>0.05). The sensitivity and specificity of detecting the HpSA by EIA were 89.2 % and 96 %, respectively; Youden′s index =0.85, Kappa =0 .86. The area under the ROC curve of PDF and non-parametric method by EIA were 0 .95 and 0.93, respectively, there was significant difference between it and 0.50 (P<0.001). Conclusions The Hp stool antigen coated by monoclonal antibody test is a simple, non -invasive method which was worth spreading in clinical application.