摘要
目的:建立丙型肝炎病毒抗体(抗-HCV)酶联免疫吸附试验(ELISA)诊断试剂评价参考系统,筛选出适合本地区的献血员抗-HCV检测策略。方法:使用Chiron的RIBA HCV 3.0试剂确认献血员中筛查出抗-HCV阳性和阴性的血清标本,建立抗-HCV参比血清,评价8种国内外抗-HCV EIA试剂的灵敏度、特异度、符合率等指标。结果:构建了抗-HCV诊断试剂评价质控体系,分别包括24份抗-HCV阳性标本、24份抗-HCV阴性标本及8份用于灵敏度评价的系列稀释标本;8种抗-HCV EIA试剂对参比血清的检测结果 Kappa值分别为0.67、0.71、0.75、0.75、0.88、0.79、0.58。结论:自制抗-HCV试剂评价体系更适合各地的试剂评价工作,在制定筛查策略时,双抗原夹心法试剂优于间接法试剂。
Objective：To establish the evaluation reference system for domestic anti-hepatitis C virus（HCV）enzyme linked immunosorbent assay（ELISA）diagnostic kits to evaluate sensitivity and specificity of 7domestic and imported anti-HCV ELISA kits by known HCV reference serum.Method：The 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 8imported and domestic anti-HCV EIA kits were evaluated with the reference serum.The coincidence of the domestic kits with imported kits was analyzed.Result：The quality control systems of diagnostic reagents of anti-HCV were constructed.Each quality control system was consisted of 56 samples,including 24 antiHCV positive,24anti-HCV negative and 8diluted specimens for sensitivity evaluation.The Kappa value of 8antiHCV EIA kits for the detection of reference serum were 0.67,0.71,0.75,0.75,0.88,0.79,0.58.Conclusion：The evaluation reference samples could offer dependable detection results and improved domestic hepatitis C diagnostic reagents.The anti-HCV ELISA reagent in double antigen sandwich method has a higher sensitivity and specificity than that in the indirect method.
出处
《临床血液学杂志（输血与检验）》
CAS
2015年第3期462-464,共3页
Journal of Clinical Hematology(Blood Transfusion & Laboratory Medicine)
基金
湖州市科研计划项目(No:2012YSB30)
