国产抗丙型肝炎抗体检测试剂盒灰区范围的设置.pdfVIP

国产抗丙型肝炎抗体检测试剂盒灰区范围的设置

陆银华;朱宇清;徐翀;赵晓君;曹丹如;朱岭峰;顾志冬

【摘要】目的：设置上海地区临床实验室常用的4种国产抗丙型肝炎病毒（HCV）

抗体（简称抗HCV）检测试剂的灰区范围。方法收集抗HCV临床初检阳性样本

656例，分别用荣盛、新波、科华和科美4家国产抗HCV检测试剂进行复检，分

别计算初检不同S/CO值范围的复检率；选择抗HCV初、复检结果不一致的弱阳

性样本338例，采用确认试验[重组免疫印迹法（RIBA）]进行确认，对RIBA结

果为不确定的样本采用实时荧光定量聚合酶链反应（PCR）检测HCVRNA。以

RIBA和HCVRNA结果作为金标准，绘制受试者工作特征（ROC）曲线，探讨其

最佳临界S/CO值。以95%真阳性和95%真阴性S/CO值确定4种国产抗HCV

检测试剂阴、阳性灰区范围。结果4种国产抗HCV检测试剂的阴性复检符合率

均90%，S/CO值均12.01；阳性复检符合率均95%。荣盛、新波、科华及科

美4种国产试剂检测抗HCV的最佳临界S/CO值分别为1.31、2.48、3.22和

4.32。分别以95%真阳性率和95%真阴性率确定4种国产抗HCV检测试剂的阳

性和阴性临界值，得出荣盛、新波、科华及科美4种国产抗HCV检测试剂S/CO

值的灰区范围分别为0.6～1.3、0.7～2.5、0.7～4.0和0.7～4.3。结论确认了上

海地区4种常用国产抗HCV检测试剂的最佳临界S/CO值，为临床提供了4种抗

HCV检测试剂的灰区范围。%ObjectiveTosetthegrayzonesof4

commonly-useddomesticanti-hepatitisCvirus(HCV)antibodydetection

kitsinclinicallaboratoriesofShanghai.MethodsAtotalof656cases

diagnosedasanti-HCVantibodypositiveinitiallywerecollected,and4

domesticanti-HCVantibodydetectionkits,Rongsheng,Xinbo,Kehuaand

Kemei,wereusedforreview.Thereviewratesofdifferentinitialdetection

signal-to-cutoff(S/CO)ratiowerecalculated,respectively.Atotalof338

weakly-positivesampleswithinconsistentinitialandreviewresultswere

chosen.Recombinantimmunoblotassay(RIBA)wasusedforvalidation

test,andforsamplesshowinguncertain,fluorescencequantitation

polymerasechainreaction(PCR)wasusedforthedetectionofHCVRNA.

TheresultsofRIBAandHCVRNAwereasgoldstandard,andreceiver

operatingcharacteristic(ROC)curvewasusedtodiscussoptimalS/COratio.

With95%truepositiveand95%truenegativeS/COratios,thenegative

andpositivegrayzonesfor4domesticanti-HCVantibodydetectionkits

wereidentified.ResultsThe4domesticanti-HCVantibodydetection

kits′negativereviewrateswere90%,S/COratioswere12.01,