From the Document: "The COVID-19 [coronavirus disease 2019] pandemic is affecting communities throughout the United States, with the country reporting the highest number of cases and deaths from the disease globally. Containment and mitigation efforts by federal, state, and local governments have been undertaken to 'flatten the curve'--that is, to slow widespread transmission that could overwhelm the nation's health care system. Diagnostic testing is a critical part of the clinical management of COVID-19, caused by the SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] virus. In addition, both diagnostic and serology testing at scale may be a key component of efforts to ease mitigation measures prior to the development, manufacture, and broad distribution of a vaccine or effective therapeutic. Efforts in the United States to rapidly develop, scale up, and disseminate testing for COVID-19 have faced challenges, including supply chain issues; a shifting regulatory landscape; a lack of consensus around federal coordination of or strategy for testing; concerns with the accuracy of both molecular and serology tests; an early lack of data on test results and capacity; and a delayed ramp-up by commercial laboratories and test manufacturers of both centralized and point-of-care testing. In addition, manufacturing and quality issues with the nation's initial test--developed by the Centers for Disease Control and Prevention (CDC)--resulted in significant delay in early access to testing throughout the country."
CRS In Focus, IF11516
Congressional Research Service: https://crsreports.congress.gov/