国产丙型肝炎诊断试剂评价质控体系的建立  

Establishment of quality control system for domestic hepatitis C diagnostic reagents

作　　者：卜秋宁[1] 王玲[1] 刘鹏[1] 王晓娟[1] 韩建[1] 陈香梅[1] 朱永红[1] 鲁凤民[1] 

机构地区：[1]北京大学医学部病原生物学系,100191

出　　处：《中华检验医学杂志》2012年第2期137-140,共4页Chinese Journal of Laboratory Medicine

基　　金：基金项目：国家科技重大专项“艾滋病和病毒性肝炎等重大传染病防治”资助项目（2008ZX10002-012）

摘　　要：目的 建立丙型肝炎诊断试剂考评用质控体系.方法 收集自2009年2至6月期间4080份献血员血清标本,用酶免疫实验检测筛选出抗-HCV阳性和抗-HCV阴性的146份标本.分别使用2种进口（Murex、Ortho）和4种国产抗-HCV EIA试剂（分别为英科新创、中山生物、万泰和科华公司）对筛选出的标本进行重复检测；使用Chiron的RIBA HCV 3.0和HCV RNA PCR试剂进行确认试验；采用Roche和Abbott HCV RNA定量试剂进行HCV RNA定量检测,RNA阳性标本进行HCV基因型检测.选择不同强度的或不同含量的确认阳性和阴性的标本及系列稀释标本建立抗-HCV和HCV RNA诊断试剂评价质控体系.结果 构建了抗-HCV和HCV RNA诊断试剂评价质控体系.每种质控体系均由50份标本组成.分别包括20份抗-HCV/HCV RNA阳性标本、20份抗-HCV/HCVRNA阴性标本及10份用于灵敏度评价的系列稀释标本.阳性标本包括强、中和弱阳性,并包含国内常见HCV基因型和亚型.阴性标本包括样本吸光度值/临界值接近临界值的标本.结论 本研究所建立的质控体系背景资料丰富、检测结果稳定可靠,为新研制和改进后国产丙肝诊断试剂的性能评价提供参考数据.Objective To evaluate the quality of domestic hepatitis C diagnostic reagents objectively,and to build up the quality control systems for assessment of hepatitis C diagnostic reagents.Methods 4080 serum samples from blood donors were collected and detected with EIA kits.146anti-HCV positive and negative samples were selected and tested repeatedly by two different imported （ Murex and Ortho） and domestic anti-HCV EIA kits（InTec,ZHONGSHAN BIO-TECH,WANTAI and KHB）,then confirmed by CHIRON RIBA HCV 3.0 and PCR qualitative reagents.The samples were tested by nucleic acid quantitative assay and the RNA positive samples were detected by genotyping reagents.Results The quality control systems of diagnostic reagents of anti-HCV and HCV RNA were constructed.Each quality control system was consisted of 50 samples,including 20 anti-HCV/HCV RNA positive,20 anti-HCV/HCV RNA negative and 10 diluted specimens for sensitivity evaluation.The positive samples with dominant HCV genotypes in China contained strong,moderate and weak positive samples.The negative samples involved those S/CO value （ signal-to-cutoff ratios ） close to threshold.Conclusion The quality control systems established in this study are suitable for assessment of the new and improved domestic hepatitis C diagnostic reagents.

关 键 词：丙型肝炎 诊断试剂 评价 质控体系 

分 类 号：R512.63[医药卫生—内科学]