For FDA Emergency Use Authorization (EUA) Only. For Prescription Use. For In Vitro Diagnostic (IVD) Use.
Designed to provide
test results in 30 minutes
3 simple steps designed to
take less than 1 minute
Designed with a simple
light up display
¹Lucira Usability Clinical Study 07A-CLI-004/005 conducted Summer 2020 (n=352)
Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus, that is comparable to some of the best molecular tests performed in clinical settings and high complexity labs.
In a Community Testing Study, where the Lucira test was compared to a FDA authorized known high sensitivity SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection1, Lucira achieved 100% positive percent agreement.
The above graph shows the Lucira COVID-19 All-In-One Test Kit positive percent agreement in the Community Testing Study. BLUE bars represent samples where the Lucira positive test result matched the comparison test result. GREY bars represent the Lucira test results that were negative and did not match the comparison test positive result. All of the GREY bars occurred in samples where there were very low levels of virus detected by the comparison test.
FDA News Release – November 17, 2020
This home test kit has not been FDA cleared or approved. This home test kit has been authorized by FDA under EUA. This home 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. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.