Assay Techniques and Test Development for COVID-19 Diagnosis
Linda J. Carter, L. Garner, Jeffrey Smoot, Yingzhu Li, Qiongqiong Angela Zhou, Catherine J. Saveson, Janet M. Sasso, Anne C. Gregg, Divya J. Soares, Tiffany R. Beskid, Susan R. Jervey, Cynthia Liu
Abstract
An ongoing theme of the COVID-19 pandemic is the need for widespread availability of accurate and efficient diagnostic testing for detection of SARS-CoV-2 and antiviral antibodies in infected individuals. This report describes various assay techniques and tests for COVID-19 diagnosis. Most tests for early detection of SARS-CoV-2 RNA rely on the reverse transcription-polymerase chain reaction, but isothermal nucleic acid amplification assays, including transcription-mediated amplification and CRISPR-based methodologies, are promising alternatives. Identification of individuals who have developed antibodies to the SARS-CoV-2 virus requires serological tests, including enzyme-linked immunosorbent assay (ELISA) and lateral flow immunoassay. This report also provides an overview of current development in COVID-19 diagnostic techniques and products to facilitate future improvement and innovation.