Integrity of SARS-CoV-2 Laboratory-Developed Tests

Author:

Genzen Jonathan R.1,Rychert Jenna1,George Tracy I.1

Affiliation:

1. ARUP Laboratories, University of Utah, Salt Lake City

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference5 articles.

1. SARS-CoV-2 laboratory-developed tests: integrity restored.;Adashi;JAMA,2022

2. Laboratory-developed tests: a legislative and regulatory review.;Genzen;Clin Chem,2017

3. Evans? BJ, Wright Clayton? E. Deadly delay: the FDA’s role in America’s COVID-testing debacle. Yale Law J. 2020;130:78-100. Accessed March 9, 2022. https://www.yalelawjournal.org/forum/deadly-delay-the-fdas-role-in-americas-covid-testing-debacle

4. Baird? RP. What went wrong with coronavirus testing in the US. New Yorker. March 16, 2020. Accessed March 8, 2022. https://www.newyorker.com/news/news-desk/what-went-wrong-with-coronavirus-testing-in-the-us

5. Authorization for Medical Products for Use in Emergencies, 21 USC §360bbb-3. Accessed March 8, 2022. https://www.law.cornell.edu/uscode/text/21/360bbb-3

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