BACKGROUND Viral load (VL) determination is an essential parameter of the management of patients infected with HIV, HBV or HCV. Many available molecular systems run on a "batch" mode while "random access" systems provide more flexibility. OBJECTIVES We compared the performance of HIV-1, HCV and HBV quantification assays on the recently developed Abbott Alinity m system to the m2000 RealTime assays. STUDY DESIGN Plasma specimens sent for viral load determination were prospectively tested on m2000 and Alinity m systems, according to manufacturers' instructions. Additional low and high tittered samples were used to assess reproducibility. RESULTS Assays concordance was evaluated from 180 samples for HIV-1, 122 for HBV, and 92 for HCV. A good correlation and a linear relation over the quantification range was observed for the three markers (r > 0.974). The Alinity m assays yielded higher results with a mean quantification bias of 0.22 log cp/ml for 75 HIV-1, 0.3 log IU/ml for 79 HBV, and 0.2 log for 35 HCV samples, though results were equivalent within an allowable difference of 0.3-0.4 log. Qualitative discordance was observed for 43/180 HIV results, 10/122 HBV and 7/92 HCV and involved undetectable or low-level VL. CONCLUSION The Alinity m assays have performance equivalent to m2000. Upon implementation, physicians should be aware of the relative overquantification compared to previous Abbott assays, particularly around clinical decision thresholds. With reduced turnarounds and hands-on times compared to the m2000 system, the Alinity m platform may improve significantly the laboratory workflow efficiency for the benefit of physicians and patients.

中文翻译：

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用Abbott Alinity m和m2000分析法比较临床样品中HIV-1，HCV和HBV的数量。

背景技术病毒载量（VL）的确定是管理感染HIV，HBV或HCV的患者的重要参数。许多可用的分子系统都以“批处理”模式运行，而“随机访问”系统则提供了更大的灵活性。目的我们比较了最近开发的雅培Alinity m系统上的HIV-1，HCV和HBV定量检测与m2000 RealTime检测的性能。研究设计根据制造商的说明，在m2000和Alinity m系统上前瞻性地测试了用于测定病毒载量的血浆标本。使用另外的滴定度高和低的样品来评估可重复性。结果从180个样本的HIV-1、122个样本的HBV和92个样本的HCV中评估了检测方法的一致性。对于这三个标记，在定量范围内观察到良好的相关性和线性关系（r> 0.974）。Alinity m分析获得了更高的结果，对于75个HIV-1，平均定量偏差为0.22 log cp / ml，对于79 HBV，为0.3 log IU / ml，对于35个HCV样品为0.2 log，尽管结果在允许的差0.3-0.4对数。观察到43/180 HIV结果，10/122 HBV和7/92 HCV的定性不一致，并且涉及不可检测或低水平的VL。结论Alinity m分析的性能等同于m2000。实施后，医师应意识到与以前的雅培测定法相比的相对定量过高，尤其是在临床决策阈值附近。与m2000系统相比，可减少周转时间和动手时间，