J Mol Diagn. Implementation of an Emergency Use Authorization Test During an Impending National Crisis

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J Mol Diagn. 2020 May 14. pii: S1525-1578(20)30325-1. doi: 10.1016/j.jmoldx.2020.05.001. [Epub ahead of print]
Implementation of an Emergency Use Authorization Test During an Impending National Crisis.


Lefferts JA¹, Gutmann EJ¹, Martin IW¹, Wells WA¹, Tsongalis GJ².

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Abstract

The laboratory response to the current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic may be termed heroic. From the identification of the novel coronavirus to implementation of routine laboratory testing around the world to the development of potential vaccines, laboratories have played a critical role in the efforts to curtail this pandemic. In this brief report, we review our own effort at a mid-sized, rural, academic medical center to implement a molecular test for the virus; and, we share insights and lessons learned from that process which might be helpful in similar situations in the future.
Copyright ? 2020. Published by Elsevier Inc.



PMID:32417222DOI:10.1016/j.jmoldx.2020.05.001