Rapid Expert Consultation on SARS-CoV-2 Laboratory Testing for the COVID-19 Pandemic (April 8, 2020) (2020) / Chapter Skim
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Rapid Expert Consultation
Rapid Expert Consultation
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Office of Science and Technology Policy Executive Office of the President Eisenhower Executive Office Building 1650 Pennsylvania Avenue, NW Washington, DC 20504 Dear Dr. Droegemeier: Attached please find a rapid expert consultation on the uses, interpretation, and future directions of laboratory tests that was prepared by David Relman, David Walt, and Kristian Andersen, members of the National Academies of Sciences, Engineering, and Medicine's Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats.
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DETECTION OF VIRAL RNA Most COVID-19 tests in current use detect the disease agent directly and measure viral RNA. Viral RNA indicates current infection and suggests infectivity and transmission risk for others; however, the presence of viral RNA in an individual, especially late in infection, may represent viral remnants rather than intact virus particles capable of transmission.
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Rapid tests that detect viral RNA include Cepheid's SARS-CoV-2 cartridge 7 for use on its rapid PCR Xpert platform with a 45-minute turn-around, and Abbott's ID NOW COVID-19 isothermal amplification test 8 for use on its ID NOW platform with results in less than 15 minutes. Both of these tests are helpful toward building local capacity, but at the time of this rapid expert consultation (April 8)
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These tests also offer useful information, but the utility and meaning of serological information are quite distinct from the utility and meaning of viral RNA diagnostic test results. Serological tests measure whether an individual has been previously exposed to the agent; however, they have also been used to complement RT-PCR results in establishing a diagnosis later in the course of illness (see also Rapid Expert Consultation on Viral Shedding and Antibody Response (April 8, 2020)
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17 Some types of viral RNA intermediates may be indicative of active replication in, or proximal to, the specimen. These RNAs are produced during the viral life cycle in a human cell but are not incorporated into the mature virus particle; thus, the presence of these RNAs indicates active replication, rather than previously assembled viable virus.
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Relman, M.D. Member Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats APPENDIX Authors and Reviewers of This Rapid Expert Consultation This rapid expert consultation was prepared by staff of the National Academies of Sciences, Engineering, and Medicine, and members of the National Academies' Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats: Kristian Andersen, The Scripps 21 Khan et al.
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The following individuals served as reviewers: Jim Chappell, Vanderbilt University Medical Center; Mark Denison, Vanderbilt University Medical Center; Michael Diamond, Washington University; Matthew Frieman, University of Maryland School of Medicine; Linsey Marr, Virginia Tech; Michael Osterholm, University of Minnesota; and Stanley Perlman, University of Iowa. Ellen Wright Clayton, Vanderbilt University Medical Center, and Susan Curry, University of Iowa, served as arbiters of this review on behalf of the National Academies' Report Review Committee and their Health and Medicine Division.
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