对五种国产核酸筛查试剂检测HIV-1RNA效果的初步评价

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-1RNA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-1 RNA含量分别为9.70×102 copies/ml和5.20×103 copies/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1.09×103 copies/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.