BIG STEP

FDA Approves First at-Home COVID-19 Self-Test

Users are to swirl the self-collected sample swab in a vial before putting it in the test unit. Within 30 minutes, test results should display.

The United States Food and Drug Administration issued an emergency use authorization on Tuesday for the first at-home self-testing COVID-19 diagnostic test that provides rapid results. The Lucira COVID-19 All-In-One Test Kit self-collected nasal swab is approved to be used by individuals over the age of 14 at home who have been prescribed by their health care provider. The molecular single-use test is also authorized to be used for any age in settings like urgent care centers, hospitals, doctor’s offices, and emergency rooms. Users are to swirl the self-collected sample swab in a vial before putting it in the test unit. Within 30 minutes, test results should display. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen Hahn said.