国产HBV DNA定量检测试剂盒(磁珠法)与COBAS AmpliPrep/COBAS TaqMan HBV DNA检测法2.0的性能评价

Evaluation and comparison of two HBV DNA quantitative assays:Roche COBAS AmpliPrep/COBAS TaqMan HBV DNA version 2.0 Test and a domestic HBV DNA quantitative reagent

目的比较国产乙型肝炎病毒核酸(HBV DNA)定量检测试剂盒(磁珠法)(简称对比试剂)与COBAS AmpliPrep/COBAS TaqMan HBV DNA检测法2.0(简称COBAS试剂)在溯源性准确度、精密度和临床应用质量方面的差异。方法用两种定量试剂分别对世界卫生组织(WHO)的HBV DNA标准品(稀释至19 975、1 998、200、60 IU/mL)进行溯源性分析,确定定量试剂检测的可靠性。然后,用两种定量试剂平行检测不同病毒载量(<20、20~100、100~200、200~2 000 IU/mL)的HBV DNA阳性临床血浆样本各25份,并评价两种定量试剂的一致性(符合率)和相关性。结果经溯源性分析,COBAS试剂组在上述4个检测节点的实测对数值与理论对数值的绝对偏差在0.001 g^0.05 lg IU/mL,在可接受范围之内(±0.3 lg IU/mL),而对比试剂组在上述4个检测节点的实测对数值与理论对数值的绝对偏差在-0.61^-0.35 lg IU/mL,均超出了可接受范围。两种试剂检测25份HBV DNA阳性血浆样本相关性较差,总符合率仅62.67%。结论COBAS AmpliPrep/COBAS TaqMan HBV DNA检测法2.0在溯源性方面一定程度优于对比HBV DNA定量检测试剂盒(磁珠法),两者在检测临床样本时的检测结果相关性较差,且临床一致性方面存在一定差距,对比HBV DNA定量检测试剂盒(磁珠法)在60~2 000 IU/mL病毒载量范围内对临床样本的判读需进一步探讨。

Objective In China,two detection products are currently in common use:the Roche COBAS AmpliPrep/COBAS TaqMan HBV DNA version 2.0 Test(′COBAS")and a CFDA-approved domestic high-sensitivity HBV DNA quantitative reagent with magnetic bead("Another HBV DNA TEST").The present study aimed to assess the traceability,stability and consistency of these two reagents.Methods The WHO HBV DNA international standard product(NIBSC 10/264)was used to evaluate the traceability of both the"Another HBV DNA TEST"reagent and CAP/CTM HBV v2 test.Each viral load was tested 20 times to assess stability.Clinical samples of different titers were collected for evaluation of consistency.Results The results showed that the absolute deviation between the COBAS assay and WHO standard sample was in the range of 0.00-0.05 lg IU/mL,while the absolute deviation between the"Another HBV DNA TEST"detection reagent and WHO standard sample was in the range of-0.61--0.35 lg IU/mL.The overall concordance rate of two assays was 62.67%.Conclusion Our study has revealed that CAP/CTM HBV v2test was superior to the comparative local reagent in traceability of HBV DNA detection.Poor consistency was observed between two assays.Further investigations are needed to confirm the performance of the local reagent in a virus load range of 60-2 000 IU/mL.