血站抗-HCV试剂参考品的建立及应用  

Establishment and Application of Anti-tlCV Reagent Reference Blood Center

作　　者：高波[1] 孙莉[1] 张磊[1] 陈冬梅[1] 

机构地区：[1]北京市红十字血液中心质监办,北京100088

出　　处：《现代检验医学杂志》2012年第2期152-154,共3页Journal of Modern Laboratory Medicine

基　　金：卫生部卫生行业科研专项药物使用安全与输血安全相关技术与标准研究资助项目（200902008）.

摘　　要：目的通过建立抗-HcV试剂参考品以用于评价血站使用的抗-HCV批批鉴定试剂。方法收集自2009年11月-201O年9月北京市红十字血液中心复检报废的抗-HCV阳性及阴性血浆各150份，所有样品均用确证试剂进行检测。根据确证结果挑选组成参考盘的阳性、阴性及精密度参考品，灵敏度参考品是通过用正常阴性血浆将阳性血浆倍比稀释后，挑选合适样品再用确证试剂栓测后获得，以上样品组成该室内部抗-HCV参考品。用A，B，C和D四种国产及进口试剂检测该室制备参考品后与国家标准参考品进行比较。结果该室内部抗-HCV试剂参考品组成包括20份阳性参考品、20份阴性参考品、4份灵敏度参考品、1份精密度参考品。用A，B，c和D四种国产及进口试剂经ELISA检测后与国家参考品比较符合率100％。结论本套参考品与国家参考品实验符合度高，灵敏度检测结果更适宜本实验室应用，稳定性良好，适合该血站内部使用。Objective To prepare the anti-HCV reagent screening and internal quality control serum plate in Beijing Red Cross Blood Center and evaluate its effect. Methods RII3A （recombinant immunoblot assay） was performed with 150 plasma sam- ples which were anti-HCV positive by the second screening, and then 20 comfirmatory positive samples were selected as pos- itive reference,3 samples whose S/CO values were about 1-6 as weak positive reference,20 comfirmatory negative samples （disruptors such as hemolytic blood,chyliformed blood, ALT and HI3sAg positive blood） as negative reference. These above references were tested compared with national standard quality control serum plate,and accessed by national diagnostic rea- gent and imported reagent after stored at -20℃ for 6 months and at 4℃ for 2 weeks. Results The conformation rate of this reference to national reference was 100%. There was no significant difference between national diagnostic reagent and imported reagent,and t value was 0. 047 % and 0. 052 %, respectively. The ranges of coefficient of variation were 5.87 % 9.03% （stored at -20℃ for 6 months） and 7.05 %-11.03 % stored at 4℃ for 2 weeks） respectively. Conclusion The set of references was in high coincidence degree with national reference serum plate. The result of sensitivity tests has shown that the references are more suitable for our laboratory than other reagents. And the references are suitable for inner use in our blood center with its good stability.

关 键 词：抗-HCV 诊断试剂 参考品 

分 类 号：R446[医药卫生—诊断学]