化学发光微粒子免疫测定技术对低风险人群HCV感染确证的应用价值

目的应用化学发光微粒子免疫测定(CMIA)技术检测一种酶联免疫吸附试验(ELISA1)反应性样本,通过HCV核酸和蛋白检测参考标准分析CMIA在献血者HCV感染确证中的应用价值。方法 102例ELISA1反应性献血者血液样本补充核酸3项联检、另一种酶联免疫吸附试验(ELISA2)、丙型肝炎病毒抗体补充试验(Western Blot法)和CMIA试验。结果 102例抗-HCV阳性献血者中,32例(31.37%,32/102)HCV RNA反应性样本,50例(49.02%,50/102)ELISA2及Western Blot均为反应性。以HCV核酸检测结果为参考标准,CMIA与之低度相关(Spearman相关系数rs=0.395,P0.01),Kappa检验两者一致性弱(Kappa=0.270,P0.01)。以ELISA2及Western Blot蛋白检测结果为参考标准,CMIA与之结果高度相关(Spearman相关系数rs=0.713,P0.01),Kappa检验两者高度一致性(Kappa=0.674,P0.01)。结论 CMIA作为HCV感染后蛋白标记物的检测方法,对低风险人群HCV病毒感染的确证有较大的应用价值。

Application value of CMIA in HCV infection validation in low risk population

Objective To detect the reactive samples of enzyme-linked immunosorbent assay (ELISA1) by chemiluminescence microparticle immunoassay (CMIA),and to analyze the application value of CMIA in HCV infection validation of blood donors.Methods Nucleic acid 3-item combined testing (NAT),another ELISA2,HCV antibody supplementary test(Western Blot test,WB) and CMIA test supplemented in blood samples of 102 ELISA1 anti-HCV reactive blood donors were retrospectively analysed.Results Among 102 blood donors of anti-HCV positive,32 cases (31.37%,32/102) were HCV RNA reactive samples,50 cases (49.02%,50/102) were ELISA2/WB reactive simultaneously.With CMIA NAT results as the reference standard,CMIA was poorly correlated with HCV RNA (Spearman correlation coefficient rs=0.395,P<0.01),and the consistency between them was weak by Kappa test (Kappa=0.270,P<0.01).With ELISA2/WB detection results as the reference standard,CMIA was highly correlated with the results(Spearman correlation coefficient rs=0.713,P<0.01),and which showed high consistency by Kappa test (Kappa=0.674,P<0.01).Conclusion CMIA as a detection method of protein label after HCV infection has great value in the HCV infection confirmation in low-risk population.