AUTHOR=Habli Zeina , Saleh Sahera , Zaraket Hassan , Khraiche Massoud L. 

TITLE=COVID-19 in-vitro Diagnostics: State-of-the-Art and Challenges for Rapid, Scalable, and High-Accuracy Screening

JOURNAL=Frontiers in Bioengineering and Biotechnology

VOLUME=Volume 8 - 2020

YEAR=2021

URL=https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2020.605702

DOI=10.3389/fbioe.2020.605702

ISSN=2296-4185

ABSTRACT=The world continues to grapple with the devastating effects of the current COVID-19 pandemic. The highly contagious nature of this raspatory disease challenges advanced viral diagnostic technologies  for rapid, scalable, affordable and high accuracy testing. Molecular assays have been the gold standard for direct detection of the presence of the viral RNA in suspected individuals, while immunoassays have been used in the surveillance of individuals by detecting antibodies against SARS-CoV-2. Unlike molecular testing, immunoassays are indirect testing of the viral infection. More than 140 diagnostic assays have been developed as of this date and have received the Food and Drug Administration (FDA) emergency use authorization (EUA). Given the differences in assays format and/or design as well as the lack of rigorous verification studies, the performance and accuracy of these testing modalities remain unclear. In this review, we aim to carefully examine commercialized and FDA approved molecular based and serological based diagnostic assays, analyze their performance characteristics and shed the light on their utility and limitations in dealing with COVID-19 global public health crisis.