The Successes and Challenges of SARS-CoV-2 Molecular Testing in the United States.

ABSTRACT

SARS-CoV-2 was identified and diagnostic methods developed at an impressive speed due in great part to the wider use of molecular methods in 2019 compared with 2002 during the SARS pandemic. The development of rapid and novel molecular diagnostic assays, leveraging of the high adaptability of molecular tests, and the integration of SARS-CoV-2 genotyping into public health, clinical, and research laboratories have been some of the successes in SARS-CoV-2 molecular testing. The main challenges are related to regulatory hurdles, supply chain constraints, and laboratory preparation.