HIV抗体确认试剂国家参考品的建立  

Establishment of National Reference for Confirmation Reagent of HIV Antibody

作　　者：宋爱京[1] 许四宏[1] 李秀华[1] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所细胞室,北京1000509

出　　处：《中国生物制品学杂志》2007年第3期209-212,共4页Chinese Journal of Biologicals

基　　金：国家十五攻关课题资助项目(编号2004BA71907)

摘　　要：目的建立评价HIV抗体确认试剂的国家参考品。方法从我国部分地区收集HIV感染者或可疑感染者以及非HIV感染者血浆样品,并对其进行HIV抗体、核酸以及抗体条带等检测,从中筛选出有代表性的样品组成参考品,用4家不同的HIV抗体确认试剂进行检测和标化。结果共筛选出27份样品组成HIV抗体确认试剂参考品,其中10份为HIV抗体确认阳性参考品,12份为HIV抗体确认阴性参考品,5份为HIV抗体不确定参考品。用4家不同的HIV抗体确认试剂标化12次,10份HIV抗体确认阳性参考品均检测为确认阳性;5份不确定参考品均检测为确认阳性或不确定,无检测为阴性者;12份阴性参考品10次均检测为确认阴性。结论该参考品可用于评价HIV抗体确证试剂的质量。Objective To establish a national reference for evaluation of confirmation reagent of HIV antibody. Methods Collect plasma sample from the patients or doubtful patients with HIV infection, as well as those from donors without HIV infection, in various regions for determination of HIV antibody, RNA and antibody band. Establish the national reference by screening the representative samples and calibrate with the HW confirmation reagents from 4 manufacturers. Results The national reference consisting of 27 samples was established ,of which 10 were confirmed as HIV antibedy-positive, 12 as negative and 5 as indefinite. After 12 calibrations, all the 10 HIV antibody-positive references were confirmed as positive, and 12 negative samples as negative. The 5 indefinite samples were confirmed as positive or indefinite, but not negative. Conclusion The established national reference might be used for the evaluation of quality of HIV antibody confirmation reagent.

关 键 词：人免疫缺陷病毒 抗体 确认试剂 

分 类 号：R392.33[医药卫生—免疫学]