现代检验医学杂志2012，Vol.27Issue(2)：152-154,3.DOI:10.3969/j.issn.1671-7414.2012.02.055
血站抗-HCV试剂参考品的建立及应用
Establishment and Application of Anti-HCV Reagent Reference Blood Center
摘要
Abstract
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 RIBA (recombinant immunoblot assay) was performed with 150 plasma samples which were anti-HCV positive by the second screening, and then 20 comfirmatory positive samples were selected as positive reference,3 samples whose S/CO values were about 1 — 6 as weak positive reference,20 comfirmatory negative samples (disrupters such as hemolytic blood,chyliformed blood, ALT and HBsAg positive blood) as negative reference. These above references were tested compared with national standard quality control serum plate,and accessed by national diagnostic reagent 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Key words
anti-HCV/diagnostic reagents/reference material分类
医药卫生引用本文复制引用
高波,孙莉,张磊,陈冬梅..血站抗-HCV试剂参考品的建立及应用[J].现代检验医学杂志,2012,27(2):152-154,3.基金项目
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). （200902008）
