ROC曲线评价酶免法检测消化病患者幽门螺杆菌  

To Evaluate the EnzymeImmunoassay (EIA) for Detecting Helicobacter Pylori Stool Antigen (HpSA) Based on ROC Curve

作　　者：王志红[1] 曹建彪[2] 闫伟[1] 

机构地区：[1]北京军区总医院消化内科,北京100700 [2]北京军区总医院肝病科,北京100700

出　　处：《科学技术与工程》2011年第12期2649-2653,共5页Science Technology and Engineering

摘　　要：为探讨消化疾病患者粪便幽门螺杆菌特异性抗原(Hp Stool antigen,HpSA)在诊断Hp感染中的临床意义,随机收集353例北京军区总医院消化内科住院和门诊患者病例,其中男性206例,女性147例,年龄范围(14—89)岁,平均年龄约49岁。入组者均空腹6 h以上,留取新鲜粪便标本,应用酶免疫法(EIA)检测HpSA,同时以13C-尿素呼气试验(13C-UBT)作为金标准。应用SPSS15.0软件对数据进行统计学分析,并绘制受试者操作特征分析曲线(Receiver Operating Characteristic curve,ROC curve),评价HpSA试验的诊断价值。χ2检验结果表明EIA法检测Hp感染与13C-UBT比较差异无显著性(p>0.05);EIA法检测HpSA敏感度94.35%,特异度98.30%,阳性预测值98.24%,阴性预测值94.54%,阳性似然比55.5,阴性似然比0.06,符合率96.32%,Youden指数0.93,Kappa值0.93;EIA法检测HpSA的ROC曲线下面积为0.944,与完全无诊断价值的机会线下面积0.50相比差异显著(p<0.001)。说明HpSA是一种非侵入性诊断Hp感染的方法,准确性和可靠性均较高,值得推广应用。To evaluate the clinical utility for the Helicobacter pylori Stool Antigen（HpSA） of the patients with digest disease,according to the randomcomparison,HpSA specimens were detected by enzyme immunoassay（EIA） in 353 patients,the evaluation of Hp infection status was defined as positive when 13C-urea breath test（13C-UBT） was positive,SPSS 15.0 software package were used to analyze the data,using the relative operating characteristic（ROC） curve,to evaluate significance of the detection of HpSA in the diagnosis of Hp infection as the area under the ROC curve.It is resulted that chi-square test show that there is not significantly different diagnosis of Hp infection by EIA which comparing the gold standard（P 0.05）.The sensitivity and specificity of the HpSA by EIA were 94.35% and 98.30%;respectively,the positive and negative predictive values are 98.24% and 94.54%;the positive and negative likelihood ratio are 55.5 and 0.06,the accuracy is 96.32%,Youden＇ index 0.93,Kappa 0.93;the area under the ROC curve of EIA is 0.944.There is significantly different between them and 0.50（P0.001）.It is conclused that HpSA is a simple,non-invasive method of high accurate and reliable test which is good for popularizing in clinical.

关 键 词：幽门螺杆菌 粪便 抗原 消化疾病 诊断试验 

分 类 号：R446.61[医药卫生—诊断学]