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大规模内部生产病毒运输介质以支持新冠疫情期间多医院医疗网络中的SARS-CoV-2 PCR检测

Large-Scale, In-House Production of Viral Transport Media To Support SARS-CoV-2 PCR Testing in a Multihospital Health Care Network during the COVID-19 Pandemic.

作者信息

Smith Kenneth P, Cheng Annie, Chopelas Amber, DuBois-Coyne Sarah, Mezghani Ikram, Rodriguez Shade, Talay Mustafa, Kirby James E

机构信息

Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.

Harvard Medical School, Boston, Massachusetts, USA.

出版信息

J Clin Microbiol. 2020 Jul 23;58(8). doi: 10.1128/JCM.00913-20.

Abstract

The COVID-19 pandemic has severely disrupted worldwide supplies of viral transport media (VTM) due to widespread demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription-PCR (RT-PCR) testing. In response to this ongoing shortage, we began production of VTM in-house in support of diagnostic testing in our hospital network. As our diagnostic laboratory was not equipped for reagent production, we took advantage of space and personnel that became available due to closure of the research division of our medical center. We utilized a formulation of VTM described by the CDC that was simple to produce, did not require filtration for sterilization, and used reagents that were available from commercial suppliers. Performance of VTM was evaluated by several quality assurance measures. Based on cycle threshold ( ) values of spiking experiments, we found that our VTM supported highly consistent amplification of the SARS-CoV-2 target (coefficient of variation = 2.95%) using the Abbott RealTime SARS-CoV-2 Emergency Use Authorization (EUA) assay on the Abbott m2000 platform. VTM was also found to be compatible with multiple swab types and, based on accelerated stability studies, able to maintain functionality for at least 4 months at room temperature. We further discuss how we met logistical challenges associated with large-scale VTM production in a crisis setting, including use of a staged assembly line for VTM transport tube production.

摘要

由于对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)逆转录聚合酶链反应(RT-PCR)检测的广泛需求,新冠疫情严重扰乱了全球病毒运输培养基(VTM)的供应。为应对这一持续的短缺情况,我们开始在内部生产VTM,以支持我们医院网络中的诊断检测。由于我们的诊断实验室没有配备试剂生产设备,我们利用了因医疗中心研究部门关闭而腾出的空间和人员。我们采用了美国疾病控制与预防中心(CDC)描述的一种VTM配方,该配方易于生产,无需过滤进行灭菌,且使用的试剂可从商业供应商处获得。通过多种质量保证措施对VTM的性能进行了评估。基于加标实验的循环阈值( )值,我们发现,使用雅培m2000平台上的雅培实时SARS-CoV-2紧急使用授权(EUA)检测方法,我们的VTM能够高度一致地扩增SARS-CoV-2靶点(变异系数=2.95%)。还发现VTM与多种拭子类型兼容,并且根据加速稳定性研究,在室温下能够保持功能至少4个月。我们进一步讨论了在危机情况下如何应对与大规模VTM生产相关的后勤挑战,包括在VTM运输管生产中使用分段装配线。

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