两种HIV-1 RNA定量检测方法的临床对比研究  

Comparison of two assays for HIV-1 RNA quantitation

作　　者：蔡侃儒[1] 程林[1] 陈伟梅[1] 黄乙甘 唐娴[1] 徐六妹[1] 何云[1] 王辉[1] CAI Kanru;CHENG Lin;CHEN Weimei;HUANG Yigan;TANG Xian;XU Liumei;HE Yun;WANG Hui(Shenzhen Third People's Hospital,Shenzhen 518112, China)

机构地区：[1]深圳市第三人民医院,广东深圳518112

出　　处：《中国艾滋病性病》2019年第1期18-21,共4页Chinese Journal of Aids & STD

基　　金：国家自然科学基金(31500750);广东省自然科学基金(2016A030313030);深圳市科技创新基金(JCYJ20160427183909738;JCYJ20170412151650600);深圳市三名工程(SZSM201512029)~~

摘　　要：目的比较达安基因艾滋病病毒1型(HIV-1)核酸检测Ⅱ代(简称达安基因)和罗氏Cobas TaqMan HIV-1Test Version 2.0(简称罗氏Cobas TaqMan)两种试剂,检测HIV-1血浆病毒载量的相关性及一致性。方法采用达安基因试剂和罗氏Cobas TaqMan试剂,平行检测663份HIV-1感染者血浆病毒载量,采用配对t检验、相关分析和Bland-Altman等方法进行统计分析。结果罗氏Cobas TaqMan与达安基因试剂检测结果高于检测下限的比例一致(分别为65.31%和65.76%)。对于病毒载量低于1 000IU/mL的样本,二者的差异无统计学意义(P=0.856 8)。罗氏Cobas TaqMan与达安基因试剂检测结果具有很强的相关性(r=0.962 0,P<0.000 1)。此外,Bland-Altman分析两种方法检测病毒载量的结果具有较高的一致性。结论达安基因和罗氏Cobas TaqMan试剂,检测HIV-1血浆病毒载量的结果具有较好的相关性和一致性。Objective To compare DaanGene’s human immunodeficiency virus type 1(HIV-1)test version 2.0(DaanGene)reagent and Roche’s Cobas TaqMan HIV-1test version 2.0(Cobas TaqMan)for HIV-1plasma viral load quantitation,and investigate the correlation and consistency of the two assays.Methods The plasma viral load of 663HIV-1infected patients was detected in parallel by DaanGene and Cobas TaqMan assays.The results obtained from the two assays were analyzed using paired t test,correlation analysis and Bland-Altman.Results The proportion of HIV-1plasma viral load above the lower limit of detection determined by Cobas TaqMan and DaanGene was consistent(65.31%and 65.76%,respectively).For samples with viral load less than 1 000IU/mL,there was no significant difference between the two assays(P=0.856 8).In addition,HIV-1plasma viral load detected by Cobas TaqMan was strongly correlated with that by DaanGene’reagent(r=0.962 0,P<0.000 1).Furthermore,Bland-Altman analysis showed that there was good consistency for the viral loads obtained from the three assays.Conclusion There are great correlation and consistency between Roche’s Cobas TaqMan and DaanGene’s HIV-1test reagents for HIV-1plasma viral load quantitation.

关 键 词：艾滋病病毒1型 病毒载量 相关性 一致性 

分 类 号：R373.9[医药卫生—病原生物学]