The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit, the first test consumers can administer completely at home.
Under the EUA, the FDA authorized the test for prescription home use with self-collected nasal swab specimens in people 14 years and older who are suspected of COVID-19 by their healthcare provider.
This test is also authorized for use at the point of care (POC), inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, with self-collected nasal swab specimens in people 14 years and older, and in individuals under 13 years when the specimen is collected by a healthcare provider at the point of care.
This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19, according to the FDA. Test results are displayed on the Test Unit via LED indicators.
