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Implementing U.S. Covid-19 Testing: Regulatory and Infrastructural Challenges

Published online by Cambridge University Press:  01 January 2021

Yongtian Tina Tan  and
Aaron S. Kesselheim
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Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue 3: A Bold Agenda for the Next Steps in Health Reform , Fall 2020 , pp. 608 - 612
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

Nishiura, H. et al., “Estimation of the Asymptomatic Ratio of Novel Coronavirus Infections (COVID-19),” International Journal of Infectious Diseases 94, no. 94 (2020): 154–155.CrossRefGoogle Scholar
Buchanan, L., Lai, K. K., and McCann, A., “US Lags in Coronavirus Testing After Slow Response to Outbreak,” New York Times, March 17, 2020, available at <https://www.nytimes.com/interactive/2020/03/17/us/coronavirus-testing-data.html> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Id.Google Scholar
Johns Hopkins Coronavirus Resource Center, COVID-19 Dashboard by the Center for Systems Science and Engineering, August 15, 2020, available at <https://coronavirus.jhu.edu/map.html> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Corman, V., Landt, O., Kaiser, M., et al., “Detection of 2019 Novel Coronavirus (2019-nCoV) by Real-Time RT-PCR,” Euro Surveillance 25, no. 3 (2020): doi.org/10.2807/1560-7917. ES.2020.25.3.2000045.Google ScholarPubMed
Sharfstein, J., Becker, S., Mello, M., “Diagnostic Testing for the Novel Coronavirus,” JAMA 323, no. 15 (2020): 1437–1438, doi:10.1001/jama.2020.3864.CrossRefGoogle ScholarPubMed
US Food and Drug Administration. “Letter from RADM Denise Hinton, M., Chief Scientist, to Robert Redfield, R., Director, Centers for Disease Control and Prevention,” March 2, 2020, available at <https://www.fda.gov/media/135763/download> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
“What are the ‘Emergency Use Authorizations’ the FDA Keeps Issuing, and How do they Reduce Barriers to COVID-19 Testing?” Advisory Board March 25, 2020, available at <https://www.advisory.com/dailybriefing/2020/03/25/emergency-use> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
“FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans,” Fierce Biotech, April 28, 2009, available at <https://www.fiercebiotech.com/biotech/fda-authorizes-emergency-use-of-influenzamedicines-diagnostic-test-responseto-swine-flu> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Coronavirus Disease 2019 Emergency Preparedness and Response, March 20, 2020, available at <https://www.fda.gov/emergency-preparednessand-response/counterterrorism-andemerging-threats/coronavirus-disease-2019-covid-19> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Reminder: COVID-19 Diagnostic Testing, Center for Disease Control Division of Laboratory Systems, Februry 18, 2020, available at <https://www.cdc.gov/csels/dls/locs/2020/reminder_covid-19_diagnostic_testing.html> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Baird, R., “What Went Wrong with the Coronavirus Testing in the US,” The New Yorker, March 16, 2020, available at <https://www.newyorker.com/news/news-desk/what-went-wrong-withcoronavirus-testing-in-the-us> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, March 20, 2020, available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratoriescertified-perform-high-complexitytesting-under-clia-prior> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
McCarty, M., “FDA's Hahn Says Need to Deploy Test for SARS-CoV-2 Across Platforms Delayed Development,” BioWorld, March 11, 2020, available at <https://www.bioworld.com/articles/433647-fdas-hahn-says-needto-deploy-test-for-sars-cov-2-across-s> (last visited August 18, 2020). (last visited August 18, 2020).' href=https://scholar.google.com/scholar?q=McCarty,+M.,+“FDA's+Hahn+Says+Need+to+Deploy+Test+for+SARS-CoV-2+Across+Platforms+Delayed+Development,”+BioWorld,+March+11,+2020,+available+at++(last+visited+August+18,+2020).>Google Scholar
Khazan, O., “The 4 Key Reasons the US is so Behind on Coronavirus Testing,” The Atlantic, March 13, 2020, available at <https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-testing-us-so-delayed/607954/> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Id.Google Scholar
Strickler, L. and Kaplan, A., “Private Labs do 85 Percent of US Covid-19 Tests But Still Struggle with Backlogs, Shortages,” NBC News, April 8, 2020, available at <https://www.nbcnews.com/health/health-news/private-labsdo-85-percent-u-s-covid-19-testsn1177866> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Herper, M. and Branswell, H., “Shortage of Crucial Chemicals Creates New Obstacle to US Coronavirus Testing,” STAT News, March 10, 2020, available at <https://www.statnews.com/2020/03/10/shortage-crucialchemicals-us-coronavirus-testing/> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Strickler, L. and Kaplan, A., supra note 17.Google Scholar
Madrigal, A. and Meyer, R., “Private Labs are Fueling a New Coronavirus Testing Crisis,” The Atlantic, March 31, 2020, available at <https://www.theatlantic.com/health/archive/2020/03/next-covid-19-testing-crisis/609193/> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Fisher, M. and Sang-Hun, C., “How South Korea Flattened the Curve,” The New York Times, March 23, 2020, available at <https://www.nytimes.com/2020/03/23/world/asia/coronavirus-south-korea-flatten-curve.html> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Kuhn, A., “South Korea's Drive-Through Testing for Coronavirus is Fast — and Free,” NPR March 13, 2020, available at <https://www.npr.org/sections/goatsandsoda/2020/03/13/815441078/south-koreas-drive-through-testingfor-coronavirus-is-fast-and-free> (last visited August 18, 2020). (last visited August 18, 2020).' href=https://scholar.google.com/scholar?q=Kuhn,+A.,+“South+Korea's+Drive-Through+Testing+for+Coronavirus+is+Fast+—+and+Free,”+NPR+March+13,+2020,+available+at++(last+visited+August+18,+2020).>Google Scholar
Engelberg, S., Song, L., and Depillis, L. “How South Korea Scaled Coronavirus Testing While in the US Fell Dangerously Behind,” ProPublica, March 15, 2020, available at <https://www.propublica.org/article/how-south-koreascaled-coronavirus-testing-while-the-us-fell-dangerously-behind> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Kuhn, A., supra note 22.Google Scholar
Bazinsky, G., “South Korea is Winning the Fight Against Covid-19. The US is Failing,” Washington Post, April 10, 2020, available at <https://www.washingtonpost.com/outlook/2020/04/10/south-korea-is-winning-fight-againstcovid-19-us-is-failing/> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Reusken, C., Broberg, E. Haagmans, B., et al., “Laboratory Readiness and Response for Novel Coronavirus (2019-nCoV) in Expert Laboratories in 30 EU/EEA Countries, January 2020,” European Surveillance 25, no. 6 (2020), doi.org/10.2807/1560-7917. ES.2020.25.6.2000082.Google Scholar
Schumacher, E., “Germany's Coronavirus Response: Separating Fact from Fiction,” DW, April 7, 2020, available at <https://www.dw.com/en/germanys-coronavirus-response-separating-fact-from-fiction/a-53053822> (last visited August 18, 2020). (last visited August 18, 2020).' href=https://scholar.google.com/scholar?q=Schumacher,+E.,+“Germany's+Coronavirus+Response:+Separating+Fact+from+Fiction,”+DW,+April+7,+2020,+available+at++(last+visited+August+18,+2020).>Google Scholar
Poltz, J. and Carrel, P., “Pass the Salt: The Minute Details that Helped Germany Build Virus Defenses,” Reuters World News, April 9, 2020, available at <https://www.reuters.com/article/us-health-coronavirus-germanydefences-i/pass-the-salt-the-minutedetails-that-helped-germany-build-virus-defenses-idUSKCN21R1DB> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
Tharoor, I., “Where Germany Had Success in Fighting Coronavirus, Britain Stumbled,” The Washington Post, April 12, 2020, available at <https://www.washingtonpost.com/world/2020/04/13/where-germanyhad-success-fighting-coronavirusbritain-failed/> (last visited August 18, 2020).CrossRef+(last+visited+August+18,+2020).>Google Scholar
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, August 15, 2020, available at <https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-useauthorizations#covid19ivd> (last visited August 18, 2020).+(last+visited+August+18,+2020).>Google Scholar
“Overview of Testing for SARS-CoV-2 (COVID 19),” Centers for Disease Control and Prevention, August 25, 2020, available at <https://www.cdc.gov/coronavirus/2019-ncov/hcp/testingoverview.html> (last visited August 29, 2020).CrossRef+(last+visited+August+29,+2020).>Google Scholar