HIV-1核酸血筛试剂国家参考品的研制  

Preparation of National Reference Panel of HIV-1 RNA for NAT Donor Screening

作　　者：许四宏[1] 宋爱京[1] 聂建辉[1] 李秀华[1] 李敬云[2] 鲍作义[2] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国人民解放军艾滋病确认实验室,北京100071

出　　处：《中国生物制品学杂志》2009年第2期174-177,共4页Chinese Journal of Biologicals

基　　金：国家十五攻关课题资助项目(2004BA71907)

摘　　要：目的研制HIV-1RNA血筛试剂国家参考品。方法收集HIV-1病毒培养物、我国不同地区的HIV-1感染者血浆以及正常人样品,经HIV-1病毒载量试剂检测,对HIV-1RNA阳性的样品进行env基因型分析,从中筛选参考品的候选样品。结果共筛选8份HIV-1RNA阳性的样品作为阳性参考品,病毒载量均高于5000IU/ml;8份HIV、HBV、HCV均为阴性的血浆样品作为阴性参考品;以1份病毒培养样品作为灵敏度参考品的原始样品,经WHOHIV-1RNA标准品标定,其HIV-1病毒载量为3.79×104IU/ml;反复3次冻融对参考品的病毒载量无明显影响。结论已制备HIV-1RNA血筛试剂国家参考品,为我国HIV-1核酸血筛试剂的质量控制和标准化提供了依据。Objective To prepare the national reference panel of HIV-1 RNA for NAT donor screening. Methods HIV-1 cultures as well as the plasma samples of healthy donors and patients with HIV-1 infection in various regions in China were collected and tested with HIV-1 viral load agent. The samples positive for HIV-1 RNA were analyzed for env genotype, from which the candidate references were screened. Results Eight samples with HIV-1 viral load of more than 5 000 IU/ml were screened as positive references, and 8 samples negative tor HIV, HBV and HCV as negative references. One HIV-1 culture with HIV-1 viral load of 3.79 × 10^4 IU/ml calibrated with WHO HIV-1 RNA standard was screened as sensitivity reference. Three cycles of freeze-thawing showed no significant effect on the viral load of the references. Conclusion The national reference panel of HIV-1 RNA for NAT donor screening was prepared, which provided a basis for the quality control and standardization of HIV-1 NAT reagents for donor screening.

关 键 词：HIV-1 RNA 核酸血筛 国家参考品 

分 类 号：R512.91[医药卫生—内科学]