A Closer Look into FDA-EUA Approved Diagnostic Techniques of Covid-19

ACS Infect Dis. 2021 Oct 8;7(10):2787-2800. doi: 10.1021/acsinfecdis.1c00268. Epub 2021 Sep 27.

Abstract

The 2019 coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 virus, caused a worldwide pandemic in 2020 and is the most urgent health issue worldwide. In this review, we highlight the details of Food and Drug Administration-Emergency Use Authorizations approved diagnostics kits, focusing on the similarities and differences. It is essential to understand the currently available options and the advantages and disadvantages each provides to select the appropriate products that maximize the testing efficiency. We believe this work will provide a holistic evaluation of the current COVID-19 diagnostic resources, including variations across the countries, and guide developing novel diagnostic techniques to improve and optimize the current testing options.

Keywords: COVID-19; FDA-EUA; molecular diagnostics; multicountry analysis; serological diagnostics.

Publication types

  • Review

MeSH terms

  • COVID-19 Testing
  • COVID-19*
  • Humans
  • Pandemics
  • SARS-CoV-2
  • United States
  • United States Food and Drug Administration