Department of Immunological and Molecular Diagnostics, University Hospital for Infectious Diseases, Zagreb, Croatia.
Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana, Slovenia.
Clin Microbiol Infect. 2020 Apr;26(4):411-420. doi: 10.1016/j.cmi.2019.09.017. Epub 2019 Sep 28.
Mobile microbiology is an evolving concept that has the potential to reduce morbidity and mortality associated with infectious diseases on a global level. Molecular methods used in the context of mobile microbiology ensure rapid and accurate aetiological diagnostics and allow timely initiation of clinical care. The great majority of published data regarding molecular diagnostics in mobile laboratories have focused on emerging viral infections and using laboratory-developed assays. Use of clinically validated and commercially available molecular diagnostic instruments in routine diagnostics of infectious diseases in mobile laboratories has received only limited attention in the field.
This review summarizes the suitability of a range of portable diagnostic molecular instruments for application in mobile laboratories by taking into account the instruments' analytical concepts, technical features and environmental requirements, as well as results of major validation studies.
Data on technical features of selected portable instruments were mainly extracted from manufacturers' websites. Information on validation studies of various molecular assays developed for the selected instruments was extracted from peer-reviewed publications searched for through PubMed.
Eight portable diagnostic molecular instruments (Alere q, GeneXpert Edge, GeneXpert Omni, Genedrive, PanNAT, Revogene, cobas Liat and ID Now) that are commercially available or in the launching stage are presented and evaluated in the context of the mobile microbiology concept, with particular emphasis on technical features and environmental requirements. Both the cobas Liat and the Alere i assays have been extensively validated in a variety of studies carried out in both adult and paediatric patients from various settings (ranging from primary care to emergency care departments in tertiary centres). Most studies showed comparable performance of cobas Liat and Alere i molecular assays with the standard-of-care in vitro diagnostics molecular assays routinely performed in dedicated/centralized molecular diagnostics laboratories. In addition, acceptable performance of Alere q and Genedrive instruments has been shown in implementations studies for early infant diagnosis of children born to human immunodeficiency virus-positive mothers and detection of hepatitis C virus RNA, respectively. Additional validation studies on existing (GeneXpert Edge, PanNAT, Revogene) and emerging (GeneXpert Omni) technologies are warranted.
Several portable molecular diagnostic platforms reviewed are suitable for mobile microbiology applications. Further development in this field should be directed toward providing a broader range of assays per instrument, multiplexing, reducing the frequency of invalid results, and price cutting.
移动微生物学是一个不断发展的概念，有可能降低全球范围内传染病的发病率和死亡率。移动微生物学中使用的分子方法确保了快速准确的病因诊断，并能及时开始临床护理。关于移动实验室分子诊断的绝大多数已发表数据都集中在新兴的病毒感染上，并使用实验室开发的检测方法。在移动实验室中，常规诊断传染病时使用经过临床验证和市售的分子诊断仪器，这在该领域只受到了有限的关注。
本综述通过考虑仪器的分析概念、技术特点和环境要求以及主要验证研究的结果，总结了一系列便携式诊断分子仪器在移动实验室中的适用性。
选定便携式仪器的技术特点数据主要从制造商的网站上提取。从通过 PubMed 搜索的同行评议出版物中提取了针对所选仪器开发的各种分子检测的验证研究信息。
介绍并评估了目前市售或处于推出阶段的 8 种便携式诊断分子仪器（Alere q、GeneXpert Edge、GeneXpert Omni、Genedrive、PanNAT、Revogene、cobas Liat 和 ID Now），特别强调了技术特点和环境要求，使其与移动微生物学概念相关联。cobas Liat 和 Alere i 检测已在各种研究中得到广泛验证，这些研究在不同环境下（从初级保健到三级中心的急诊部门）的成人和儿科患者中进行。大多数研究表明，cobas Liat 和 Alere i 分子检测与在专门/集中分子诊断实验室中常规进行的标准体外诊断分子检测的性能相当。此外，在针对艾滋病毒阳性母亲所生儿童的早期婴儿诊断和丙型肝炎病毒 RNA 检测的实施研究中，分别显示了 Alere q 和 Genedrive 仪器的可接受性能。需要进一步验证现有的（GeneXpert Edge、PanNAT、Revogene）和新兴的（GeneXpert Omni）技术。
综述中评估的几种便携式分子诊断平台适用于移动微生物学应用。该领域的进一步发展应致力于为每个仪器提供更广泛的检测范围、多重检测、减少无效结果的频率和降低价格。
