November 18, 2020
On November 17, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first diagnostic test that individuals can use at home to test themselves for COVID-19. The test can also be used by healthcare providers in point-of-care settings, such as emergency rooms, hospitals, healthcare practitioners’ offices, and urgent care centers. Although previous tests were authorized for self-collecting nasal samples at home, the samples had to be shipped to laboratories for testing. The newly authorized test is a rapid PCR test that detects the genetic material of SARS-CoV-2, the virus that causes COVID-19. The test is authorized for use at home by individuals age 14 and older who are thought to have COVID-19 by their healthcare practitioners. Children younger than age 13 must be tested in a healthcare setting.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Stephen M. Hahn, M.D in a press release. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
For more information, read the November 17, 2020 FDA Press Release and the agency’s FAQs on Diagnostic Testing for SARS-CoV-2.
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