国产抗丙型肝炎抗体检测试剂盒灰区范围的设置

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 HCV RNA。以 RIBA 和 HCV RNA 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。%Objective To set the gray zones of 4 commonly-used domestic anti-hepatitis C virus(HCV)antibody detection kits in clinical laboratories of Shanghai. Methods A total of 656 cases diagnosed as anti-HCV antibody positive initially were collected,and 4 domestic anti-HCV antibody detection kits,Rongsheng,Xinbo,Kehua and Kemei,were used for review. The review rates of different initial detection signal-to-cut off(S/CO)ratio were calculated,respectively. A total of 338 weakly-positive samples with inconsistent initial and review results were chosen. Recombinant immunoblot assay(RIBA)was used for validation test,and for samples showing uncertain,fluorescence quantitation polymerase chain reaction(PCR)was used for the detection of HCV RNA. The results of RIBA and HCV RNA were as gold standard,and receiver operating characteristic(ROC)curve was used to discuss optimal S/CO ratio. With 95% true positive and 95% true negative S/CO ratios,the negative and positive gray zones for 4 domestic anti-HCV antibody detection kits were identified. Results The 4 domestic anti-HCV antibody detection kits′negative review rates were > 90%,S/CO ratios were >12.01,and their positive review rates were > 95%. The optimal S/CO ratios for Rongsheng,Xinbo,Kehua and Kemei were 1.31,2.48,3.22 and 4.32,respectively. With 95% true positive rates and 95% true negative rates for determining 4 domestic anti-HCV antibody detection kits′positive and negative cut-off values,the gray zones for optimal S/CO ratios were 0.6-1.3,0.7-2.5,0.7-4.0 and 0.7-4.3,respectively. Conclusions The 4 commonly-used domestic anti-HCV antibody detection kits′optimal S/CO ratios are confirmed. It provides 4 kinds of gray zones for anti-HCV antibody detection kits in clinic.