Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany.
Microbiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12) Madrid, Spain.
J Clin Virol. 2017 Jul;92:75-82. doi: 10.1016/j.jcv.2017.05.003. Epub 2017 May 11.
Viral load monitoring is essential for patients under treatment for HIV. Beckman Coulter has developed the VERIS HIV-1 Assay for use on the novel, automated DxN VERIS Molecular Diagnostics System. OBJECTIVES: Evaluation of the clinical performance of the new quantitative VERIS HIV-1 Assay at multiple EU laboratories.
Method comparison with the VERIS HIV-1 Assay was performed with 415 specimens at 5 sites tested with COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, 169 specimens at 3 sites tested with RealTime HIV-1 Assay, and 202 specimens from 2 sites tested with VERSANT HIV-1 Assay. Patient monitoring sample results from 4 sites were also compared.
Bland-Altman analysis showed the average bias between VERIS HIV-1 Assay and COBAS HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay to be 0.28, 0.39, and 0.61 log cp/mL, respectively. Bias at low end levels below 1000cp/mL showed predicted bias to be <0.3 log cp/mL for VERIS HIV-1 Assay versus COBAS HIV-1 Test and RealTime HIV-1 Assay, and <0.5 logcp/mL versus VERSANT HIV-1 Assay. Analysis on 174 specimens tested with the 0.175mL volume VERIS HIV-1 Assay and COBAS HIV-1 Test showed average bias of 0.39 logcp/mL. Patient monitoring results using VERIS HIV-1 Assay demonstrated similar viral load trends over time to all comparators.
The VERIS HIV-1 Assay for use on the DxN VERIS System demonstrated comparable clinical performance to COBAS HIV-1 Test, RealTime HIV-1 Assay, and VERSANT HIV-1 Assay.
病毒载量监测对于接受 HIV 治疗的患者至关重要。贝克曼库尔特公司开发了 VERIS HIV-1 检测试剂盒，用于新型自动化 DxN VERIS 分子诊断系统。目的：在多个欧盟实验室评估新型定量 VERIS HIV-1 检测试剂盒的临床性能。
在 5 个地点用 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test，v2.0 对 415 个标本进行方法比较，在 3 个地点用 RealTime HIV-1 Assay 对 169 个标本进行方法比较，在 2 个地点用 VERSANT HIV-1 Assay 对 202 个标本进行方法比较。还比较了 4 个地点的患者监测样本结果。
Bland-Altman 分析显示，VERIS HIV-1 检测试剂盒与 COBAS HIV-1 Test、RealTime HIV-1 Assay 和 VERSANT HIV-1 Assay 的平均偏差分别为 0.28、0.39 和 0.61 log cp/mL。在低于 1000cp/mL 的低值水平下，VERIS HIV-1 检测试剂盒相对于 COBAS HIV-1 Test 和 RealTime HIV-1 Assay 的预测偏差小于 0.3 log cp/mL，相对于 VERSANT HIV-1 Assay 的预测偏差小于 0.5 logcp/mL。对用 0.175mL 体积 VERIS HIV-1 检测试剂盒和 COBAS HIV-1 Test 检测的 174 个标本进行分析，平均偏差为 0.39 logcp/mL。用 VERIS HIV-1 检测试剂盒进行患者监测的结果表明，病毒载量随时间的变化趋势与所有比较试剂相似。
用于 DxN VERIS 系统的 VERIS HIV-1 检测试剂盒的临床性能与 COBAS HIV-1 Test、RealTime HIV-1 Assay 和 VERSANT HIV-1 Assay 相当。
