【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。更多还原

【Abstract】 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 candi-date 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 for HIV,HBV and HCV as negative references.One HIV-1 culture with HIV-1 viral load of 3.79×104 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.更多还原