At Home COVID Tests

Please find links to the test kit package insert, instructions, information for healthcare providers and information about the FDA Emergency Use Authorization:

Lucira Check It COVID-19 Test Kit Package Insert Instructions for Use

Lucira Check It COVID-19 Test Long Form Instructions for Use

Fact Sheet for Healthcare Providers

Lucira Check It COVID-19 Test Kit FDA EUA Authorization Letter

Important Information about the FDA Emergency Use Authorization:

The Lucira Check It COVID-19 Test Kit has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Indications for Use:

The Lucira Check It COVID-19 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 over-the-counter (OTC) use with self-collected nasal swab samples in individuals with or without COVID-19 symptoms aged 14 and older, and in children aged 2-13 collected by an adult. This test is similar to a PCR test in that it utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.

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. Negative results are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary, for patient management may be performed.

For use under the Food and Drug Administration’s Emergency Use Authorization only.

Test results can be reported through the LUCI secure portal, to relevant public health authorities in accordance with local, state, and federal requirements.

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

Important Information about the FDA Emergency Use Authorization:

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and
• This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.