对五种国产核酸筛查试剂检测HIV-1 RNA效果的初步评价  

Primary Evaluation on the Capacity of Five Domestic NAT Donor Screening Assays in Detecting HIV-1 RNA

作　　者：许四宏[1] 宋爱京[1] 聂建辉[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,北京100050

出　　处：《临床输血与检验》2011年第1期15-17,20,共4页Journal of Clinical Transfusion and Laboratory Medicine

基　　金：国家科技支撑计划"原料血浆病毒安全性评价技术研究"(No.2008BAI54B08)资助

摘　　要：目的对5种国产HBV/HCV/HIV-1核酸筛查试剂(A、B1、B2、C和D)检测HIV-1 RNA的能力进行初步评价。方法从我国不同地区收集60份HIV-1感染者样品(包含1份HIV-1感染窗口期样品)及540份HIV阴性样品,将60份HIV-1感染者样品随机分布于540份HIV阴性样品中,按照合并检测模式(pool模式)对该600份样品进行检测,将每种试剂检测结果为阳性的pool分别按说明书进一步拆分和/或鉴别试验。结果 A、B1、B2和C四种试剂检测HIV-1 RNA的效果较强,其阴性和阳性符合率均为100%;D试剂则较差,其中2份HIV-1感染者样品(基因型分别为BC和B/B′,HIV-1RNA含量分别为9.70×102copies/ml和5.20×103copies/ml)分别处于2个pool中,该2个pool经D试剂检测,均为HIV-1 RNA阴性。对检测结果为阳性的35个pool进行拆分检测时,D试剂检测1份HIV-1感染者样品(B/B′亚型、HIV-1 RNA含量为1.09×103copies/ml)为HIV-1 RNA阴性,3份HIV-1 RNA阴性样品为HIV-1 RNA阳性。对于1份HIV-1感染窗口期样品,5种试剂均检测为HIV-1 RNA阳性。结论 A、B1、B2和C四种试剂均有较高的一致性,但D试剂具有一定的假阳性和漏检,应进一步提高质量。Objective To evaluate the capacity of five domestic NAT donor screening assays of HBV DNA,HCV RNA and HIV-1 RNA（A,B1,B2, C and D assays） in detecting HIV-1 RNA.Methods 60 HIV-1 positive plasma were collected from HIV-1-infected individuals and 540 HIV-1 negative plasma were collected from donors with negative for anti-HIV in different regions in China.The 60 samples positive for HIV-1 RNA were randomly distributed into 540 negative samples for HIV-1 RNA.Mini-pool test and further discrimination test were completed according to the manufactures′ instruction of the five assays.Results For A,B1,B2 and C assays,the coincidence rates of HIV-1 infected and negative samples for HIV were 100%.However,for D assay,2 pools containing one HIV-1 genotype BC sample（viral load： 9.70×102 copies/ml） and 1 genotype B/B′ sample（viral load： 5.20×103 copies/ml）,respectively,were detected as negative for HIV-1 RNA,and in further discrimination test,the 35 pools were detected as positive for HIV-1 RNA,1 HIV-1 infected sample（genotype： B/B′,HIV-1 viral load： 1.09×103 copies/ml） was detected as negative for HIV-1 RNA,three samples negative for HIV-1 RNA were detected as positive for HIV-1 RNA.For all the 5 assays,1 sample at the window period of HIV-1 infection was detected as positive for HIV-1 RNA.Conclusions Higher efficient performance was found on four assays,A,B1,B2 and C assays.However,for D assay,the false negative results were found in pool test and further discrimination test,and false positive result was found in discrimination test.Thus further improvement on the quality of D assay should be made.

关 键 词：HBV HCV HIV-1 国产核酸筛查试剂 

分 类 号：R373[医药卫生—病原生物学] R392.11[医药卫生—基础医学]