应用全自动核酸检测系统MPLC-COBAS筛查献血员HIV-1 RNA

Automated assay system for detection of human immunodeficiency virus type1

目的建立一套全自动核酸检测系统筛检献血员艾滋病病毒1型(HIV-1)核糖核酸(RNA)。方法应用MagNAPureLC(MPLC)系统提取核酸,COBASAmplicor系统进行基因扩增与检测,再应用国际标准品和临床标本验证MPLC-COBAS系统。结果该系统的检测灵敏度(95%CI)HIV1RNA病毒为45～67IU/ml,5124份标本混样检测结果为阴性,81份HIV抗体(抗HIV)酶联免疫吸附试验(ELISA)假阳性混样检测结果及6份追踪样本核酸检测结果均为阴性。结论该系统具有全自动检测、灵敏度高、特异性好的特点,可进一步扩大临床标本检测量,探索出切实有效的核酸检测系统进行献血员筛查HIV1RNA。

Objective To establish automatic nucleic acid testing(NAT)to screen human immunodeficiency virus-1(HIV-1)RNA.Method Using MagNA Pure LC(MPLC)for RNA extraction,COBAS Amplicor for amplification and detection,we also test international standards and clinical specimens.Results The sensitivity of the NAT for HIV-1 RNA is 45-67IU/ml,all the clinical specimen are negative,including 5,124 screened as ELISA negative,81 screened as anti-HIV false positive and 6 follow-up.Conclusion MPLC-COBAS is fully automated and highly sensitive,with good specificity.We can test more clinical specimens to find out efficient NAT way for screening HIV-RNA.