基于qPCR的两种试剂在HIV-1病毒载量检测中的比较研究  

Comparative study on the performance of two qPCR-based assays for HIV-1 viral load

作　　者：付钰淋[1] 任强[1] 常文辉[1] 邹扬帆[1] Fu Yulin;Ren Qiang;Chang Wenhui;Zou Yangfan(Department of AIDS Prevention and Control,Shanxi Province Center for Disease Control and Prevention,Xi’an 710054,China)

机构地区：[1]陕西省疾病预防控制中心艾滋病预防控制所,西安710054

出　　处：《国际病毒学杂志》2023年第2期115-119,共5页International Journal of Virology

摘　　要：目的比较两种实时荧光定量PCR试剂检测HIV-1病毒载量间的相关性和一致性,以及性能参数。方法两种检测试剂各采用3个批号对系列稀释的定值质控品检测,分析两种检测试剂的检测线性度和精密度。再用两种试剂对166例HIV抗体阳性样品和27例阴性样品分别进行检测,比较两者的相关性和一致性。结果TaqMan病毒载量检测试剂与系列浓度定值质控品检测结果的决定系数为R2=0.978,Xpert病毒载量检测试剂与系列浓度定值质控品检测结果的决定系数为R2=0.987;对不同浓度定值质控品检测结果的不同批号间和总变异系数均<7%。两种试剂不同批号检测定值质控品的结果差异无统计学意义。两种试剂对血浆样本检测结果显示,对阴性样品检测的符合率为100%,在40 cps/mL的临界值处的观察一致性为50%,在其量化下限附近缺乏一致性,线性范围内检测结果之间的决定系数为R2=0.946。Bland-Altman分析显示,偏差均值为0.41 log10(IU/mL)。结论两种试剂检测性能均良好,在HIV-1病毒载量检测中具有较好的临床等效性。Objective To analyze the correlation and consistency between two real-time fluorescent quantitative PCR assays in the detection of HIV-1 viral load and to obtain the performance criteria.Methods Three batches of each reagent with different lot numbers were selected to test serially diluted quantification control materials to assess the linearity and precision.Both reagents were also used to analyze 166 HIV-positive and 27 HIV-negative samples to compare the correlation and consistency between the two assays.Results The coefficients of determination for serially diluted quantification control materials by COBAS AmpliPrep COBAS TaqMan HIV-1 test(version 2.0)and GeneXpert HIV-1 viral load assay were 0.978(R2=0.978)and 0.987(R2=0.987),respectively.The inter-batch and overall coefficients of variation of serially diluted quantification control materials were all<7%.There were no statistically significant differences in the results of serially diluted quantification control materials by different batches of both reagents.The test results of plasma samples indicated that the rate of agreement for negative samples was 100%.The observer agreement rate was 50%at the level of cut-off value,which was 40 cps/mL,indicating lacking of agreement reaching the lower limits by the two assays.Within the linear range,the coefficient of determination for the test results was 0.946(R2=0.946).Bland-Altman analysis showed a mean difference of 0.41 log10 IU/mL.Conclusions Both assays showed good performance in the test and had well clinical equivalence for detection of HIV-1 viral load.

关 键 词：HIV-1 病毒载量 实时荧光定量PCR 

分 类 号：R446.5[医药卫生—诊断学]