Clinical Microbiology and Virology, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.
Clinical Microbiology and Virology, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.
J Clin Virol. 2018 Sep;106:7-10. doi: 10.1016/j.jcv.2018.06.015. Epub 2018 Jun 25.
Viral load measurement is routine for the management of patients infected with HIV, HCV or HBV, using sensitive, quantitative, nucleic acid amplification tests (NAATs). However, platforms are not equivalent in terms of turnaround time, random access capability and operator hands-on time.
We compared the performance of the Hologic Panther transcription-mediated amplification based Aptima assays for HIV, HBV and HCV viral load measurement with the corresponding Abbott m2000 RealTime assays. All Aptima assays were run according to the manufacturer's instructions, on archived patient samples for HIV (n = 251 including subtypes 01_AE, A (A1), B, BG recombinant, C CRF02_AG and G), HBV (n = 117 including genotypes A, B, C and D) and HCV (n = 82 including genotypes 1, 2, 3 and 4). Additional testing was performed with WHO international standards and expanded HIV-1 subtype and HCV NIBSC genotype panels.
The Hologic Panther Aptima assays for HIV-1 RNA, HBV DNA and HCV RNA viral load measurements performed equivalently to the Abbott m2000 RealTime assays. The performance of the Aptima assays was also acceptable on the WHO and NIBSC standards and subtype/genotype panels.
The Aptima Panther platform offers equivalent clinical performance for the viral load measurement of these three viruses, with the added benefits of reduced turnaround time, random access capability and reduced 'hands-on time' for staff, resulting in a potentially superior workflow for diagnostic laboratories.
使用灵敏、定量的核酸扩增检测（NAAT）对 HIV、HCV 或 HBV 感染患者进行病毒载量检测是常规管理。然而，在检测周转时间、随机检测能力和操作人员手动操作时间方面，不同的检测平台并不相同。
我们比较了基于转录介导扩增的 Hologic Panther 检测系统与相应的 Abbott m2000 RealTime 检测系统用于 HIV、HBV 和 HCV 病毒载量检测的性能。所有 Aptima 检测均按照制造商的说明，在 HIV（n=251，包括 01_AE、A（A1）、B、BG 重组、C CRF02_AG 和 G 亚型）、HBV（n=117，包括基因型 A、B、C 和 D）和 HCV（n=82，包括基因型 1、2、3 和 4）的存档患者样本上进行。使用世界卫生组织国际标准和扩展的 HIV-1 亚型和 HCV NIBSC 基因型面板进行了额外的检测。
Hologic Panther Aptima 检测系统用于 HIV-1 RNA、HBV DNA 和 HCV RNA 病毒载量测量的性能与 Abbott m2000 RealTime 检测系统相当。Aptima 检测系统在世界卫生组织和 NIBSC 标准以及亚型/基因型面板上的性能也可以接受。
Aptima Panther 平台为这三种病毒的病毒载量测量提供了等效的临床性能，具有检测周转时间更短、随机检测能力更强、操作人员手动操作时间更少的优势，从而为诊断实验室提供了潜在更优的工作流程。
