3种血浆HIV-1 RNA定量方法检测质量评价

COMPARATIVE EVALUATION OF THREE ASSAYS FOR THE QUANTITATION OF HIV-1 RNA IN PLASMA.

目的:评价3种血浆HIV-1 RNA定量方法的检测质量效果。方法:120份HIV-1阳性血浆样本分别用Amplicor、NASBA和bDNA2.0试剂盒测定其HIV-1 RNA浓度,之后对其敏感性、相关性以及批内和批间重复性进行统计学分析。结果:3种试剂盒对120份血浆样本的检测敏感性分别为75.83%(Amplicor)、66.67%(NASBA)和70.00%(bDNA2.0);平均HIV-1RNA浓度(log10拷贝/ml)分别为4.12±0.92(Amplicor)、4.05±0.88(NASBA)和4.04±0.77(bDNA 2.0);相关性比较中,差异有<0.50 log10的样本百分率分别为73.96%(Amplicor-bDNA2.0)、72.41%(NASBA-bDNA2.0)和68.09%(Amplicor-NASBA);批内重复性分析中,差异<0.50 log10的样本百分率分别为96.55%(Amplicor)、85.71%(NASBA)和100.00%(bDNA2.0);批间重复性分析中,差异<0.50 log10的样本百分率分别为96.77%(Amplicor)、83.33%(NASBA)和96.77%(bDNA2.0)。结论:3种病毒载量检测试剂盒定量血浆HIV-1RNA方法可靠,敏感性接近,相关性和重复性良好。

Objective： To evaluate the quantifying abilities of three assays for HIV - 1 RNA in plasma. Methods： HIV-1 RNA levels of 120 anti- HIV - 1 sero - positive specimens were tested by Amplicor, NASBA and bDNA2.0, respectively. The sensitivities, reproducibilities and correlations were evaluated for the three methods. Results： Among 120 anti - HIV- 1 sero- positive specimens, the detection sensitivities were 75.83% by Amplicor, 66.67% by NASBA and 70.00% by bDNA2.0, respectively. The percentages of the specimens with correlations differing less than 0.50 log10 were 73.96 % between Amplicor and bDNA 2.0, 72.41% between NASBA and bDNA 2.0 and 68.09% between Amplicor and NASBA, respectively. The percentages of the specimens with within-run reproducibilities differing less than 0.50 log10 were 96.55% for Amplicor, 85.71% for NASBA and 100.00 % for bDNA 2.0; and the percentages of the specimens with between-run reproducibilkies differing by less than 0.50 log10 were 96.77% for Amplicor, 83.33% for NASBA and 96.77% for bDNA 2.0. Conclusion： All three assays have colose sensitivities, reproducibilities and correlations. They are suitable and reliable for determining HIV- 1 RNA concentration in plasma.