Please find links to the test kit package insert, instructions, information for healthcare providers and information about the FDA Emergency Use Authorization:
Lucira COVID-19 All-in-One Test Kit Package Insert Instructions for Use
Lucira COVID-19 All-in-One Test Kit Long Form Instructions for Use
Lucira COVID-19 All-in-One Test Kit FDA EUA Letter
Lucira COVID-19 All-In-One Test Kit Healthcare Provider Fact Sheet
Lucira COVID-19 All-In-One Test Kit Healthcare Provider Reporting Guidance
Lucira COVID-19 Test Kit Emerging SARS-CoV-2 Strains
Indications for Use:
The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 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), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19.
Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience
COVID-like symptoms should seek follow up care from their healthcare provider. For use under the Food and Drug Administration’s Emergency Use Authorization (EUA) only.
COVID-19 can present with severe illness in individuals of any age and without any previous health problems, but the risk for severe illness from COVID-19 increases with age, with older adults at highest risk. Having underlying medical conditions may also increase one’s risk for severe illness from COVID-19. Regardless of your risk status, if you are experiencing any of the following emergency warning signs for COVID-19, it is recommended that you immediately seek emergency care:
Trouble breathing
Persistent pain or pressure in the chest
New confusion
Inability to wake up or stay awake
Bluish lips or face