ROC曲线对ELISA法检测HBsAg阳性判断值的确定及应用评价  

Confirmation and Application Evaluation of Cut-off Value in HBsAg Test by ELISA with Receive Operation Curve

作　　者：康炜[1] 辛娜[1] 尤涛[1] 李建华[1] 郑乃青 李卓[1] 田宇[1] 白跳艳 

机构地区：[1]西安医学院附属医院检验科,西安710077

出　　处：《现代检验医学杂志》2010年第6期49-50,54,共3页Journal of Modern Laboratory Medicine

摘　　要：目的 应用受试者工作特征（ROC）曲线对ELISA法定性检测乙型肝炎表面抗原（HBsAg）的cut-off值进行确定,并将确定结果应用于低水平HBsAg阳性标本进行综合评价.方法 采用酶联免疫吸附法（ELISA）检测1 021例乙型肝炎HBsAg血清学标志物,对从中筛选出的195例低水平HBsAg阳性标本进行化学发光微粒子免疫分析法定量,并对两种方法的结果进行评价.结果 195例HBsAg低水平阳性标本,经化学发光微粒子免疫分析法定量阳性190例（97.4%）,阴性1例（0.5%）,不确定4例（2.1%）.ROC曲线分析结果显示,当ELISA检测HBsAg的A值在0.11时,灵敏度和特异度的比例较为合适,特异度为97.1%,敏感度为98.6%,用0.11作cut-off值对195例低水平HBsAg阳性标本重新判读结果,与应用试剂盒本身根据公式计算的cut-off值判读结果进行比较结果差异无统计学意义.结论 ELISA实验目前广泛使用的根据公式计算cut-off值判读结果的方法是可行的,能够满足临床的基本需求.Objective To confirm the cut-off value in HBsAg test by ELISA with receive operation curve and evaluate the results of low level HBsAg by applying the new cut-off value. Methods 1 021 samples HBsAg was tested by ELISA,195 low level HBsAg positive samples were detected by mieropartlcalenzyme immunofluorescence assay （MEIA）. Results Among 195 low level HBsAg positive samples,190 （97.4%） were confirmed,and only 1 sample （0. 5%） was negative and 4 samples （2.1%） were uncertain. According to the receiver operating characteristic （ROC） curve,when the cut-off value was 0.11,the specificity was 97.1% and the sensitivity was 98.6%. Confirmed the positive and negative samples with new cut-off value and compared with the result confirmed by the cut-off value calculated by the formula,there was no significance in the two methods. Conclusion The cut-off value which was widely used by kit is available in clinical application.

关 键 词：乙型肝炎表面抗原 cut—off值 ROC曲线 

分 类 号：R446.61[医药卫生—诊断学]