Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Ramat-Gan, Israel.
Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
PLoS One. 2019 Feb 19;14(2):e0211079. doi: 10.1371/journal.pone.0211079. eCollection 2019.
Respiratory viral infections constitute the majority of samples tested in the clinical virology laboratory during the winter season, and are mainly diagnosed using molecular assays, namely real-time PCR (qPCR). Therefore, a high-quality extraction process is critical for successful, reliable and sensitive qPCR results. Here we aimed to evaluate the performance of the newly launched eMAG compared to the fully automated MagNA PURE 96 (Roche, Germany) and to the semi-automated easyMAG (bioMerieux, France) extraction platforms. For this analysis, we assessed and compared the analytic and clinical performance of the three platforms, using 262 archived respiratory samples positive or negative to common viruses regularly examined in our laboratory (influenza A, B, H1N1pdm, Respiratory Syncytial Virus (RSV), human Metapneumovirus (hMPV), parainfluenza-3, adenovirus and negative samples). In addition, quantitated virus controls were used to determine the limit of detection of each extraction method. In all categories tested, eMAG results were comparable to those of the easyMAG and MagNa PURE 96, highly sensitive for all viruses and over 98% clinical specificity and sensitivity for all viruses tested. Together with its high level of automation, the bioMerieux eMAG is a high-quality extraction platform enabling effective molecular analysis and is mostly suitable for medium-sized laboratories.
呼吸道病毒感染在冬季临床病毒学实验室检测样本中占大多数，主要通过分子检测方法（即实时 PCR(qPCR)）进行诊断。因此，高质量的提取过程对于成功、可靠和敏感的 qPCR 结果至关重要。在这里，我们旨在评估新推出的 eMAG 与全自动 MagNA PURE 96（罗氏，德国）和半自动 easyMAG（生物梅里埃，法国）提取平台的性能。为此，我们使用在我们实验室定期检测的常见病毒（甲型流感、乙型流感、H1N1pdm、呼吸道合胞病毒（RSV）、人偏肺病毒（hMPV）、副流感-3、腺病毒和阴性样本）检测的 262 个存档呼吸道样本，评估和比较了这三个平台的分析和临床性能。此外，还使用定量病毒对照来确定每种提取方法的检测限。在所有测试类别中，eMAG 的结果与 easyMAG 和 MagNa PURE 96 的结果相当，对所有病毒均高度敏感，对所有测试病毒的临床特异性和敏感性均超过 98%。eMAG 与高水平的自动化相结合，是一种高质量的提取平台，能够进行有效的分子分析，最适合中型实验室。
