Implementation of an Emergency Use Authorization Test During an Impending National Crisis

J Mol Diagn. 2020 Jul;22(7):844-846. doi: 10.1016/j.jmoldx.2020.05.001. Epub 2020 May 14.

Abstract

The laboratory response to the current severe acute respiratory syndrome coronavirus 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 midsized, 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.

Publication types

  • Review

MeSH terms

  • Betacoronavirus / isolation & purification*
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / standards*
  • Clinical Laboratory Techniques / statistics & numerical data
  • Coronavirus Infections / diagnosis*
  • Coronavirus Infections / prevention & control
  • Coronavirus Infections / virology
  • Delivery of Health Care / organization & administration*
  • Emergencies*
  • Health Plan Implementation*
  • Humans
  • Laboratories / legislation & jurisprudence*
  • Laboratories / standards
  • Pandemics / prevention & control
  • Pneumonia, Viral / diagnosis*
  • Pneumonia, Viral / prevention & control
  • Pneumonia, Viral / virology
  • SARS-CoV-2