Large-scale, in-house production of viral transport media to support SARS-CoV-2 PCR testing in a multi-hospital healthcare network during the COVID-19 pandemic.
Large-scale, in-house production of viral transport media to support SARS-CoV-2 PCR testing in a multi-hospital healthcare network during the COVID-19 pandemic.
复制标题
大规模、内部生产病毒传输介质，以支持 COVID-19 大流行期间多医院医疗保健网络中的 SARS-CoV-2 PCR 检测。
DOI：
10.1101/2020.04.29.20085514
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
Kirby,JamesE
中科院分区：
文献类型：
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作者：
Smith,KennethP;Cheng,Annie;Chopelas,Amber;DuBois-Coyne,Sarah;Mezghani,Ikram;Rodriguez,Shade;Talay,Mustafa;Kirby,JamesE
由于对严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）逆转录- pcr （RT-PCR）检测的广泛需求，COVID-19大流行严重扰乱了全球病毒运输介质（VTM）的供应。为了应对这种持续的短缺，我们开始在内部生产VTM，以支持我们医院网络中的诊断测试。由于我们的诊断实验室没有生产试剂的设备，我们利用了由于我们医疗中心的研究部门关闭而可用的空间和人员。我们使用了CDC描述的VTM配方，该配方生产简单，不需要过滤灭菌，并使用了商业供应商提供的试剂。通过几种质量保证措施对VTM的性能进行了评价。基于峰值实验的周期阈值（CT）值，我们发现我们的VTM支持在雅培m2000平台上使用雅培实时SARS-CoV-2紧急使用授权（EUA）检测高度一致的SARS-CoV-2靶扩增（变异系数= 2.95%）。研究人员还发现，VTM与多种类型的拭子兼容，并且根据加速稳定性研究，VTM能够在室温下保持至少4个月的功能。我们进一步讨论了如何在危机环境下应对与大规模VTM生产相关的后勤挑战，包括使用VTM输送管生产的分段装配线。
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 (CT) 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.