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Adapting to the Coronavirus Pandemic: Building and Incorporating a Diagnostic Pipeline in a Shared Resource Laboratory
Cytometry Part A ( IF 3.7 ) Pub Date : 2020-10-29 , DOI: 10.1002/cyto.a.24248
Emma Russell 1 , Ana Agua-Doce 1 , Lotte Carr 1 , Asha Malla 1 , Kerol Bartolovic 1 , Dina Levi 1 , Carl Henderson 1 , Debipriya Das 1 , Hefin Rhys 1 , Philip Hobson 1 , Sukhveer Purewal 1 , Andrew Riddell 1
Affiliation  

In March 2020, with lockdown due to the coronavirus pandemic underway, the Francis Crick Institute (the Crick) regeared its research laboratories into clinical testing facilities. Two pipelines were established, one for polymerase chain reaction and the other for Serology. This article discusses the Cricks Flow Cytometry Science Technology Platform (Flow STP) role in setting up the Serology pipeline. Pipeline here referring to the overarching processes in place to facilitate the receipt of human sera through to a SARs‐CoV‐2 enzyme‐linked immunosorbent assay result. We examine the challenges that had to be overcome by a research laboratory to incorporate clinical diagnostics and the processes by which this was achieved. It describes the governance required to run the service, the design of the standard operating procedures (SOPs) and pipeline, the setting up of the assay, the validation required to show the robustness of the pipeline and reporting the results of the assay. Finally, as the lockdown started to ease in June 2020, it examines how this new service affects the daily running of the Flow STP. © 2020 The Authors. Cytometry Part A published by Wiley Periodicals LLC on behalf of International Society for Advancement of Cytometry.

中文翻译:

适应冠状病毒大流行:在共享资源实验室中建立和整合诊断管道

2020 年 3 月,由于冠状病毒大流行正在进行封锁,弗朗西斯·克里克研究所 (Crick) 将其研究实验室重新调整为临床测试设施。建立了两条管道,一条用于聚合酶链反应,另一条用于血清学。本文讨论了克里克斯流式细胞术科学技术平台 (Flow STP) 在建立血清学管道中的作用。此处的管道指的是促进接收人体血清到 SARs-CoV-2 酶联免疫吸附测定结果的总体流程。我们研究了研究实验室必须克服的挑战,以纳入临床诊断以及实现这一目标的过程。它描述了运行服务所需的治理、标准操作程序 (SOP) 和管道的设计,分析的设置,显示管道稳健性所需的验证并报告分析结果。最后,随着锁定在 2020 年 6 月开始放松,它研究了这项新服务如何影响 Flow STP 的日常运行。© 2020 作者。细胞术 A 部分由 Wiley Periodicals LLC 代表国际细胞术进步协会出版。
更新日期:2020-10-29
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