血液筛查抗-HIV检验试剂质量相关参数分析  

Analysis of the quality parameters of HIV antibody reagent for blood screening

作　　者：徐研[1] 张小英[2] 高加良[1] 

机构地区：[1]成都市血液中心,四川成都610041 [2]成都医学院

出　　处：《中国输血杂志》2014年第3期276-278,共3页Chinese Journal of Blood Transfusion

基　　金：四川卫生厅课题(120501)

摘　　要：目的对国产的5种抗-HIV检测试剂进行质量比较。方法采用抗-HIV质控血清盘、标准浓度为2NCU/mL的质控血清及常规的血液样品对5种国产的ELISA试剂进行灵敏度、特异性、精密性、最低检测限、板间变异系数及反应模式的均一性等参数分析。结果抗-HIV的ELISA检测试剂质量参数存在差异;常规血液样品S/CO结果分布显示反应模式的均一性有差别。结论血液筛查实验室对抗-HIV ELISA试剂的选择,应该在参照参考品的考核结果的同时,结合试剂盒本底均一性等综合因素进行。Objective To evaluate the quality of 5 types of HIV antibody reagents. Methods The quality parameters such as sensitivity, specificity, precision, minimum detection limit, inter-plate coefficient of variation and uniformity of re-sponse mode were analyzed by using anti-HIV control serum plate,2 NCU/mL quality control serum and routine blood sam-ples. Results The quality parameters of HIV antibody ELISA reagent are different. The S/CO of routine blood samples showed that there were differences in the reaction modes. Conclusion Blood screening laboratory for anti-HIV ELISA rea-gent selection, in accordance with the reference material results, it should be combined with kit background homogeneity fac-tors at the same time.

关 键 词：抗-HIV ELISA试剂 血液筛查 质量评价 

分 类 号：R457.1[医药卫生—治疗学] R446.6[医药卫生—临床医学]