应用ROC曲线评价酶免疫法检测粪便幽门螺杆菌特异性抗原试验的临床价值  

To Evaluate the Clinical Utility for Detecting Helicobacter Pylori Stool Antigen(HpSA) in Feces by Enzyme Immunoassay(EIA) Based on ROC Curve

作　　者：闫伟[1] 曹建彪[1] 王志红[1] 王继恒[1] 

机构地区：[1]北京军区总医院消化内科,北京100700

出　　处：《中国现代医学杂志》2010年第7期971-975,979,共6页China Journal of Modern Medicine

摘　　要：目的探讨粪便幽门螺杆菌(Hp)特异性抗原(HpSA)在诊断Hp感染中的临床价值。方法按照随机、对照、盲法的原则,采用酶免疫法(EIA)检测353例因上消化道症状就诊于该院消化内科门诊或住院患者的HpSA,以13C-尿素呼气试验检查(13C-UBT)作为诊断Hp感染的"金标准",应用ROCKIT for windows 1.1β软件和SPSS15.0软件对数据进行统计学分析,应用不拘分布形式参数法(拟合双正态模型参数法)和非参数法分别绘制光滑受试者操作特征分析曲线(receiver operating characteristic curve,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"比较差异无显著性(P>0.05);诊断试验的一般指标: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%,优势比963.03,Youden指数0.93,Kappa值0.93;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0.966和0.944,与完全无诊断价值的机会线下面积0.50相比差异有显著性(P<0.001)。结论HpSA是一种非侵入性诊断Hp感染的方法,该法简便易行,准确性和可靠性均较高,值得临床进一步推广。【Objective】To evaluate the clinical utility for the diagnosis of Helicobacter pylori（Hp） infection by enzyme immunoassay（EIA） for detecting Hp stool antigen（HpSA） in feces.【Methods】According to the random comparison and double-blind,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,ROCKIT for windows 1.1 β software and SPSS 15.0 software package were used to analyze the data,using the relative operating characteristic（ROC） curve with Parametric distribution-free approach（PDF）and non-parametric method,to evaluate significance of the detection of HpSA in the diagnosis of HP infection as the area under the ROC curve（Az）.【Results】The chi-square test show that there was not significantly significant 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 were 98.24% and 94.54%,respectively;the positive and negative likelihood ratio were 55.5 and 0.06,respectively;the accuracy was 96.32%,the odds ratio was 963.03,Youden＇s index=0.93,Kappa=0.93;the area under the ROC curve of Parametric distribution-free approach（PDF） and non-parametric method by EIA were 0.966 and 0.944,respectively.There was significantly different between them and 0.50（P0.001）.【Conclusions】The Hp stool test is a simple,non-invasive method which was worth spreading in clinical.The EIA method for Hp antigen testing is better in high accurate and reliable test for the diagnosis of Hp infection.

关 键 词：螺杆菌 幽门 粪便 抗原 诊断试验 

分 类 号：R446.61[医药卫生—诊断学]