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1 1 (April 23, 2020)

handle is hein.crs/govdabh0001 and id is 1 raw text is: -....... .dr . . .. April 23, 2020 COVID-19 Testing: Key Issues The COVID-19 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 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. For more information, see CRS Report R46261, Development and Regulation of Domestic Diagnostic Testing for Novel Coronavirus (CO VID-19): Frequently Asked Questions. Public health testing may be used to help identify and contain the spread of a novel pathogen early in its introduction into the country, as well as to detect and monitor ongoing outbreaks. This testing relies on the CDC and the U.S. network of state and local public health laboratories, including some Department of Defense and international laboratories. In contrast, clinical diagnostic testing is carried out by a number of facilities, including private commercial laboratories (e.g., LabCorp); hospital and other clinical laboratories; and laboratories in academic medical centers and universities. These two systems, while overlapping and connected, have distinct purposes. Clinical testing may be centralized-a sample is collected and sent to a central laboratory for testing-or decentralized, or occurring at or near the patient or point of care, commonly referred to as point-of-care testing. Diagnostic testing for COVID-19, in part because it is caused by a novel pathogen, was initially carried out by the country's network of public health laboratories. However, it is generally not the role of the public health laboratories to carry out the large-scale clinical diagnostic testing needed during a pandemic response, and demand outstripped supply quickly as the country transitioned to community spread. The commercial sector-including commercial laboratories and commercial test kit manufacturers-as well as clinical laboratories in hospitals and at universities are seen as critical to achieving the scope of testing needed during the COVID-19 public health emergency. Despite ramping up capacity across U.S. laboratories of all types, the country's network of laboratories continues to face challenges meeting the unprecedented demand for testing, in terms of volume, speed, and accuracy. Currently the country performs approximately 150,000 tests per day, and a significant increase in capacity would likely require additional infrastructure (more testing platforms, standing up additional laboratory facilities), in addition to maintaining testing at full current capacity. Testing for COVID-19 currently involves both molecular tests and immunoassays. Diagnostic testing for COVID-19 generally relies on molecular tests that use nucleic acid amplification techniques such as polymerase chain reaction (PCR) to detect viral genetic material. These tests identify viral nucleic acid in samples taken from individuals' noses or throats using swabs. This type of test is technically complex but well-characterized, generally requiring both specific instruments and highly trained laboratory personnel. PCR tests may be high-throughput, so many samples may be run simultaneously, but the run time is generally several hours. PCR tests may be laboratory- developed tests (LDTs), test kits, or point-of-care tests. Point-of-care tests are usually faster and simpler to run, but often only run a single or a few samples at one time. COVID-19 testing may also be carried out using immunoassays. This type of test detects immune system proteins made by the host (antibodies) or viral components that stimulate the host's immune response (antigens). Tests that detect antibodies in the blood are called serology tests, and they generally indicate either late active infection or exposure to and recovery from prior infection. Serology tests are not generally used alone for diagnosis of disease; rather, they may sometimes be used in combination with a molecular test for diagnosis. Serology testing also may be used to identify individuals who can donate convalescent plasma as a possible therapeutic; to help guide development of a vaccine; and to determine the extent and spread of COVID-19 in the general population, as well as the infection fatality rate. Rapid antigen tests-which have not yet been authorized for use in the United States for COVID- 19-can detect viral antigens, generally in a throat or nose swab. These tests are usually point-of-care, low-cost, easy to use, and used for diagnostic purposes. However, these Wy's C.,, , yg\\ y gmm, Ngm 10M ILI

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