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Rapid Expert Consultation on SARS-CoV-2 Laboratory Testing for the COVID-19 Pandemic (April 8, 2020)
Pages 47-54

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From page 47...
... 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.
From page 48...
... 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.
From page 49...
... This is an important finding in the event that current shortages of RNA extraction kits continue or worsen. One approach for increasing the scale of PCR testing relies on pooling samples for initial screening, with follow-up testing of subsets of the original pool if the initial screen produces a positive result.13 While early tests of this approach are promising and this  5 Thai et al.
From page 50...
... 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)
From page 51...
... 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. The identification and development of assays for these non-packaged replicative RNA intermediates may have clinical utility in predicting an increased likelihood of the presence of infectious virus.
From page 52...
... SUMMARY The two general classes of diagnostic tests, one to detect viral RNA and the other to detect human antibodies directed against the virus, each provide a distinct set of benefits and weaknesses. Detection of viral RNA generally indicates active, ongoing infection and suggests infectiousness for others, especially early in the course of infection, although the persistence of detectable viral RNA weeks after infection may no longer be synonymous with a virus capable of causing infection.
From page 53...
... 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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