一种新型国产试剂检测HIV-1病毒载量

Evaluation of a new domestic reagent for detection of HIV-1 viral load

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 new domestic high - precision magnetic HIV PCR fluormetric diagostic kit in detecting the HIV viral load. Methods A total of 219 plasma samples were collected from HIV- 1/AIDS individuals for detecting RNA viral load with Roche COBAS TAQMAN48 and a domestic reagent. The detection results of the two reagents were compared. Results There was a linear relation between the viral load revealed by the two reagents, and the distribut- ions of the high, middle and low viral load were not significantly different. The results were not consistent within the viral load range from log3 to log4. Conclusions The gap between the new domestic diagnc^stie regent and Roche COBAS TAQMAN48 in detection performance is narrowing although the regent needs to be improved in sensitivity for detecting low viral load and sta- bility for middle viral load.