两种HIV-1核酸定量检测试剂盒v2.0的对比研究  

Comparison of the two assays for HIV-1 viral load quantitation

作　　者：李繁[1] 蒋岩[1] 屈然 小尼玛[1] 潘品良[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心,北京102206

出　　处：《中国艾滋病性病》2014年第3期146-148,153,共4页Chinese Journal of Aids & STD

基　　金：国家科技重大专项(2012ZX10001001-001-002)~~

摘　　要：目的比较罗氏COMBAS AmpliPrep/COMBAS TaqMan HIV-1Test version 2.0(简称TagMan v2.0试剂)和生物梅里埃NucliSENS EasyQ HIV-1v2.0(简称EasyQ v2.0试剂)两种试剂,检测艾滋病病毒Ⅰ型(HIV-1)病毒载量间的相关性和一致性。方法对40份血浆样本采用TaqMan EasyQ v2.0试剂和EasyQ v2.0试剂分别检测HIV-1病毒载量。统计学处理采用配对t检验、回归分析和Bland-Altman分析。结果 TaqMan v2.0和EasyQ v2.0试剂测得的病毒载量均值分别为(4.41±0.72)log10拷贝/mL和(3.75±0.75)log10拷贝/mL,差异有统计学意义(t=10.441,P<0.001)。对两种试剂的检测结果进行回归分析表明,两种试剂有较强的相关性(R2=0.817)。用Bland-Altman分析比较两种试剂检测结果的差异均值,结果具有较好的一致性。结论 TaqMan v2.0和EasyQ v2.0两种试剂盒在检测HIV-1病毒载量时具有较好的相关性和一致性。Objective To compare the Roche＇s COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0with the NucliSENS EasyQ HIV-1 v2.0 for HIV-1 viral load quantitation, and investigate the correlation and con-sistency of the two assays. Methods Viral load was detected by Roches COBAS AmpliPrep/COBAS TaqManHIV-1 Test version 2.0 and Biomerieux NucliSENS EasyQ HIV-1 v2.0 assay in parallel for 40 plasma samples. Theresults of two assays were compared by paired t-test, regression analysis and Bland-Ahman plot. Results The aver-age HIV-1 viral loads detected by TaqMan kit and EasyQ kit were（4.41±0.72）1og10 copies/ml and（3.75±0.75）log10 copies/ml respectively,and the difference between the two assays（t= 10. 441, P〈0. 001）was statistically sig-nificant. There was a strong correlation of the quantifiable VLs between the two kits （R2 =0. 817）. Bland Altmanplot showed that there was good consistency for the mean VL differences obtained from the two assays. Conclusions This study showed that there was a good correlation and consistency between the Roche＇s COMBAS AmpliPrep/COMBAS TaqMan HIV-1 Test version 2.0 kit and the BIOMERIEUX NucliSENS EasyQ HIV-1 v2.0 kit for HIV-1 viral load quantitation.

关 键 词：Ⅰ型艾滋病病毒 病毒载量 罗氏COBASTaqMan 生物梅里埃EasyQ 

分 类 号：R373.9[医药卫生—病原生物学]