Assay Techniques and Test Development for COVID-19 Diagnosis

TLDR

The COVID‑19 pandemic underscores the need for widespread, accurate, and efficient diagnostic testing for SARS‑CoV‑2 RNA and antiviral antibodies, with RT‑PCR as the standard but promising isothermal and CRISPR‑based alternatives emerging. The report aims to describe current assay techniques for COVID‑19 diagnosis and to overview ongoing development of diagnostic methods and products to guide future improvement and innovation. Diagnostic methods include RT‑PCR for viral RNA, isothermal amplification and CRISPR‑based assays, and serological ELISA and lateral‑flow tests, with the report summarizing ongoing development of these techniques.

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.