不同抗-HCV酶联免疫试剂性能指标评价

卜秋宁; 王玲; 刘鹏; 王晓娟; 韩建; 陈香梅; 鲁凤民; 庄辉

doi:10.11847/zgggws2013-29-03-24

不同抗-HCV酶联免疫试剂性能指标评价

Evaluation on performance index of different domestic and imported anti-HCV EIA kits

摘要

摘要: 目的用已知参比血清评价国内外6种抗-丙型肝炎病毒(HCV)酶免疫试验(EIA) 的灵敏度、特异度、符合率等性能。方法从献血员中筛查出抗-HCV阳性和阴性的血清标本,建立抗-HCV参比血清;应用该参比血清评价2种进口(Murex和Ortho)和4种国产抗-HCV EIA试剂的灵敏度、特异度、符合率等指标。结果6种抗-HCV EIA试剂对参比血清的检测结果灵敏度分别为92.16%、92.16%、90.20%、94.12%、90.20%和92.16%,特异度分别为94.44%、64.81%、90.74%、88.89%、96.30%和79.63%,符合率为85.71%~93.33%;对参比血清的检测结果,4种国产试剂与Murex一致性较好,Kappa值>0.6,且国产试剂与Murex的符合率普遍高于与Ortho试剂的符合率。结论改进后的4种国产和2种进口抗-HCV EIA试剂灵敏度接近,但6种国内外试剂的特异性差异较大。

Abstract: ObjectiveTo evaluate sensitivity and specificity of 6 domestic and imported anti-hepatitis C virus(HCV) enzyme immunoassay(EIA) kits by known HCV reference serum.MethodsThe anti-HCV positive and negative specimens selected from blood donors were set up as anti-HCV reference serum.The sensitivity,specificity,and coincidence rates of 2 imported(Murex and Ortho) and 4 domestic anti-HCV EIA kits were evaluated with the reference serum.The coincidence of the domestic kits with imported kits was analyzed.ResultsThe sensitivity of 6 anti-HCV EIA kits for the detection of reference serum were 92.16%,92.16%,90.2%,94.12%,90.2%,and 92.16% and the specificity was 94.44%,64.81%,90.74%,88.89%,96.3%,and 79.63%,respectively.The coincidence rates ranged from 85.71% to 93.33%。The coincidence of 4 domestic kits with Murex was better for the detection of reference serum,with a Kappa value of >0.6,and the coincidence rate of domestic kits with Murex was generally higher than that of with Ortho.ConclusionThe sensitivity of 4 improved domestic and imported anti-HCV EIA kits is similar,however,the specificity varies from each other.

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