两种HIV-1核酸定量检测试剂盒v2．0的对比研究

目的 比较罗氏COMBAS AmpliPrep／COMBAS TaqMan HIV—1 Test version 2．0（简称TagMan v2．0试剂）和生物梅里埃NucliSENS EasyQ HIV-1 v2．0（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。

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

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.