Food and Drug Administration (FDA) has authorized the first coronavirus disease 2019 (COVID-19) diagnostic test for self-testing at home through an emergency use authorization (EUA). The Lucira COVID-19 All-In-One Test Kit has been authorized for home use for individuals age 14 and older and suspected of COVID-19 by their health care providers, and is authorized for prescription use only. In addition, the test is authorized for use in point-of-care (POC) settings (eg, doctors’ offices, hospitals, urgent care centers, and emergency rooms) for all ages, but samples must be collected by a health care provider when the test is used at the POC to test individuals younger than 14 years old.
FDA notes that while COVID-19 diagnostic tests have been authorized for at-home collection, this authorization is a significant step forward as this is the first test that can be fully self-administered and provide results at home. More information is available in a FDA news release.
NABP is a 501(c)(3) nonprofit association that protects public health by assisting its member boards of pharmacy and offers programs that promote safe pharmacy practices for the benefit of consumers.
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Personalized Wellness, Point-of-Care Services
