一种国产HIV-1核酸定量试剂与罗氏试剂的临床对比研究
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摘要
目的对比分析一种国产人类免疫缺陷病毒1型(HIV-1)核酸定量试剂和进口罗氏试剂检测HIV-1血浆病毒载量的相关性和一致性。方法收集2018年1-5月期间在深圳市第三人民医院就诊的HIV/AIDS患者临床检测剩余血浆样本652份,采用某国产HIV-1核酸定量检测Ⅰ代试剂(简称国产试剂)和罗氏Cobas TaqMan HIV-1 Test Version 2.0试剂,平行检测HIV-1感染者血浆病毒载量,采用配对t检验、线性回归和Bland-Altman等方法,对检测结果进行统计分析,评价两种检测试剂检测结果的相关性和一致性。结果进口与国产试剂检测结果均高于或均低于检测下限的样本分别为362例和209例,检测结果一致性较高,达到87.58%(571/652)。两种试剂检测结果均高于检测下限的362例样本中,国产试剂和进口试剂检测的平均病毒载量分别为(74 642±11 077)IU/mL和(103 694±14 883)IU/mL,差异有统计学意义(t=3.842,P=0.000 1)。两种检测方法在病毒载量高于1 000 IU/mL时差异有统计学意义(t=3.867,P=0.000 1),但是在病毒载量低于1 000 IU/mL时差异并无统计学意义(t=1.074,P=0.285 2)。相关性分析显示,两种方法检测结果具有很强的相关性(r=0.962 0,P<0.000 1);差异分析显示,Cobas TaqMan与国产试剂定量值差异平均值为-0.009 2 log10IU/mL,95%可信区间为(-0.641 6～0.623 2)log10IU/mL,95%(344/362)的样本检测值在95%可信区间内。结论国产试剂与和罗氏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 the correlation and consistency of a domestic human immunodeficiency virus type 1(HIV-1) test kit and a imported kit in detecting HIV-1 plasma viral load. Methods The HIV-1 plasma viral loads of 652 HIV-1 infected patients were detected in parallel by a domestic HIV-1 test kit version 1.0(domestic reagent) and Roche's Cobas TaqMan HIV-1 test version 2.0(imported reagent). The HIV-1 viral loads determined by the two assays were analyzed by paired t test, linear regression and Bland-Altman to assess the correlation and consistency between the domestic reagent and the imported reagent. Results The results of HIV-1 plasma viral load from 362 samples were both above the lower limit of detection(LOD) and 209 samples were both below the LOD determined by the imported and domestic reagents. The consistency of the two reagents was 87.58%(571/652). The mean HIV-1 plasma viral loads of the 362 samples determined by the domestic and the imported reagent were(74 642± 11 077) IU/mL and( 103 694± 14 883) IU/mL,respectively, with significant differences(t=3.842, P=0.000 I). Importantly, for samples with viral load less than 1 000 IU/mL, there was no significant difference between the two assays( t=1.074, P=0.285 2). In addition, HIV-1 plasma viral loads detected by the two assays were strongly correlated(r=0.962 0,P<0.00 1). Bland-Altman analysis showed that the average difference between the imported and the domestic reagents was-0.009 2 log10 IU/mL, and the 95% confidence interval was(-0.641 6,0.623 2) log10 IU/mL. Conclusion There was a great correlation and consistency between the domestic and the imported reagent in the detection of HIV-1 plasma viral load.
Objective To compare the correlation and consistency of a domestic human immunodeficiency virus type 1(HIV-1) test kit and a imported kit in detecting HIV-1 plasma viral load. Methods The HIV-1 plasma viral loads of 652 HIV-1 infected patients were detected in parallel by a domestic HIV-1 test kit version 1.0(domestic reagent) and Roche's Cobas TaqMan HIV-1 test version 2.0(imported reagent). The HIV-1 viral loads determined by the two assays were analyzed by paired t test, linear regression and Bland-Altman to assess the correlation and consistency between the domestic reagent and the imported reagent. Results The results of HIV-1 plasma viral load from 362 samples were both above the lower limit of detection(LOD) and 209 samples were both below the LOD determined by the imported and domestic reagents. The consistency of the two reagents was 87.58%(571/652). The mean HIV-1 plasma viral loads of the 362 samples determined by the domestic and the imported reagent were(74 642± 11 077) IU/mL and( 103 694± 14 883) IU/mL,respectively, with significant differences(t=3.842, P=0.000 I). Importantly, for samples with viral load less than 1 000 IU/mL, there was no significant difference between the two assays( t=1.074, P=0.285 2). In addition, HIV-1 plasma viral loads detected by the two assays were strongly correlated(r=0.962 0,P<0.00 1). Bland-Altman analysis showed that the average difference between the imported and the domestic reagents was-0.009 2 log10 IU/mL, and the 95% confidence interval was(-0.641 6,0.623 2) log10 IU/mL. Conclusion There was a great correlation and consistency between the domestic and the imported reagent in the detection of HIV-1 plasma viral load.
引文
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[11]Ryscavage P,Kelly S,Li JZ,et al.Significance and clinical management of persistent low-level viremia and very-low-level viremia in HIV-1-infected patients[J].Antimicrob Agents Chemother,2014,58(7):3585-3598.
[12]Helou E,Shenoi S,Kyriakides T,et al.Characterizing patients with very-low-level HIV viremia:a community-based study[J].J Int Assoc Provid AIDS Care,2017,16(3):261-266.
[13]Nightingale S,Geretti AM,Beloukas A,et al.Discordant CSF/plasma HIV-1 RNA in patients with unexplained low-level viraemia[J].J Neurovirol,2016,22(6):852-860.
[14]Garner W,White K,Szwarcberg J,et al.Concordance of HIV-1RNA values by amplicor and TaqMan 2.0 in patients with confirmed suppression in clinical trials[J].Clin Infect Dis,2016,62(7):929-934.
[2]中国疾病预防控制中心.2018年第2季度全国艾滋病性病疫情[J].中国艾滋病性病,2018,24(8):755.
[3]中国疾病预防控制中心.2018年第3季度全国艾滋病性病疫情[J].中国艾滋病性病,2018,24(11):1075.
[4]张岭,蒋岩,潘品良.HIV-1病毒载量检测常用技术及研究进展[J].传染病信息,2015,28(6):352-356.
[5]刘昶权,何溪,张国明,等.高效抗逆转录病毒治疗法对艾滋病患者血脂水平的影响[J].热带医学杂志,2017,17(10):1332-1334.
[6]Mossoro-Kpinde CD,Jenabian MA,Gody JC,et al.Evaluation of the Upgraded Version 2.0 of the Roche COBAS?AmpliPrep/COBAS?TaqMan HIV-1 Qualitative Assay in Central African Children[J].Open AIDS J,2016,10:158-163.
[7]Carmona S,Peter T,Berrie L.HIV viral load scale-up:multiple interventions to meet the HIV treatment cascade[J].Curr Opin HIV AIDS,2017,12(2):157-164.
[8]Peter T,Ellenberger D,Kim AA,et al.Early antiretroviral therapy initiation:access and equity of viral load testing for HIVtreatment monitoring[J].Lancet Infect Dis,2017,17(1):e26-e29.
[9]Sollis KA,Smit PW,Fiscus S,et al.Systematic review of the performance of HIV viral load technologies on plasma samples[J].PLoS One,2014,9(2):e85869.
[10]Hermans LE,Moorhouse M,Carmona S,et al.Effect of HIV-1low-level viraemia during antiretroviral therapy on treatment outcomes in WHO-guided South African treatment programmes:a multicentre cohort study[J].Lancet Infect Dis,2018,18(2):188-197.
[11]Ryscavage P,Kelly S,Li JZ,et al.Significance and clinical management of persistent low-level viremia and very-low-level viremia in HIV-1-infected patients[J].Antimicrob Agents Chemother,2014,58(7):3585-3598.
[12]Helou E,Shenoi S,Kyriakides T,et al.Characterizing patients with very-low-level HIV viremia:a community-based study[J].J Int Assoc Provid AIDS Care,2017,16(3):261-266.
[13]Nightingale S,Geretti AM,Beloukas A,et al.Discordant CSF/plasma HIV-1 RNA in patients with unexplained low-level viraemia[J].J Neurovirol,2016,22(6):852-860.
[14]Garner W,White K,Szwarcberg J,et al.Concordance of HIV-1RNA values by amplicor and TaqMan 2.0 in patients with confirmed suppression in clinical trials[J].Clin Infect Dis,2016,62(7):929-934.