Emerging Health IssuesFDAMedical Technology

At-Home SARS-CoV-2 Diagnostic Tests Could be a Breakthrough, But What Are the Limitations?

(By Brittni Frederiksen, Ivette Gomez, and Alina Salganicoff for Kaiser Family Foundation)

The first SARS-CoV-2 diagnostic test with a home collection option by LabCorp received emergency use authorization (EUA) from the Food and Drug Administration (FDA) on April 21, 2020. LabCorp is initially prioritizing healthcare workers and first responders and then expects to make the tests available more broadly. At-home tests may be a promising avenue to get more people tested in a timely manner and also reduce the risk of exposure in health care settings. An at-home SARS-CoV-2 test would not be the first at-home test for an infectious disease. For several years now, Americans have been able to purchase at-home sexually transmitted infection (STI) tests from online sellers, and experiences with these tests can offer some lessons on the challenges that we might anticipate with the widespread adoption of at-home SARS-CoV-2 testing.  Continue reading paper here…

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