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目的评价一种新型国产高精度磁珠法实时荧光定量核酸检测试剂在人类免疫缺陷病毒1型(HIV-1)病毒载量检测中的应用。方法收集219份HIV-1感染者/艾滋病(AIDS)患者血浆样本,同时采用国产磁珠法试剂和罗氏COBAS TAQMAN48系统进行病毒载量检测,比较两种方法所得数据间的关系。结果两种不同试剂检测出的病毒载量结果存在一定的线性关系,在高中低三个域值内的分布差异无统计学意义,但是在log3~4范围内,偏差较大。结论这种新型国产试剂在低载量的检测敏感性和中载量的稳定性方面还需进一步优化,但在检测性能上与国际上最常用的罗氏试剂之间的差异在逐步缩小。
Objective To evaluate the application of a novel home-made high-precision magnetic beads real-time fluorescent quantitative nucleic acid detection reagent in the detection of human immunodeficiency virus type 1 (HIV-1) viral load. Methods A total of 219 plasma samples of HIV-1 / AIDS patients were collected. The viral load was detected by domestic magnetic bead reagent and Roche COBAS TAQMAN48 system. The relationship between the data obtained by the two methods was compared. Results There was a certain linear relationship between the results of two different reagents. There was no significant difference in the distribution of high, middle and low three domains, but the deviation was large in the range of log3 ~ 4. Conclusion The new domestic reagents need to be further optimized for low sensitivity and medium loading stability. However, the difference between the detection performance and the most commonly used Roche reagent in the world is gradually decreasing.