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In March 2020, with lockdown due to the coronavirus pandemic underway, the Francis Crick Institute (the Crick) re-geared its research laboratories into clinical testing facilities. Two pipelines were established one for PCR and the other for Serology. This paper 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 (ELISA) 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 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. This article is protected by copyright. All rights reserved.
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Cytometry._Part_A_:_the_journal_of_the_International_Society_for_Analytical_Cytology
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Adapting to the Coronavirus Pandemic: Building and Incorporating a Diagnostic Pipeline in a Shared Resource Laboratory.
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