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With continued community transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the US, there has been sustained focus on the role of testing to mitigate and suppress spread. After the first case of coronavirus disease 2019 (COVID-19) was diagnosed in the US in mid-January 2020, testing lagged behind due to challenges with test validation at the Centers for Disease Control and Prevention. In late February 2020, the US Food and Drug Administration (FDA) eased its restrictions on Emergency Use Authorization, which led to a rapid increase in the number of authorized tests. By May 2020, the private sector was performing 99% of US COVID-19 testing. By August 2020, the number of SARS-CoV-2 tests peaked and then plateaued at approximately 1 million tests per day. Multiple parallel efforts to bring diagnostic innovation to COVID-19 testing are underway and are likely to result in more tests as well as new innovative platforms. For instance, the Rapid Acceleration of Diagnostics program is a $1.5-billion US government program launched by the National Institutes of Health to support development, production scale-up, and deployment of rapid tests with a goal of 6 million tests available per day.1
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Corresponding Author: Yukari C. Manabe, MD, Johns Hopkins University, 1830 E Monument St, Room 443, Baltimore, MD 21287 (email@example.com).
Published Online: November 13, 2020. doi:10.1001/jama.2020.21694
Conflict of Interest Disclosures: Dr Manabe reported receiving grants from Becton-Dickinson, Hologic, Quanterix, and miDiagnostics outside the submitted work. No other disclosures were reported.
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