The Lucira COVID-19 All-In-One Test Kit is the First and Only FDA EUA Molecular Prescription At Home Test Kit
Only US licensed healthcare providers can purchase on this page. If you are interested in purchasing our over-the-counter product, click here.
Lucira Test Kit Demonstration
Our clinical studies show 100% of users 14 and older were able to run our test.¹
¹Lucira Usability Clinical Study 07A-CLI-004/005 conducted Summer 2020 (n=352)
Lucira’s technology has been in development for over 5 years. The moment for accurate, molecular at-home testing is now.
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 the Hologic Panther Fusion, one of the highest sensitivity RT-PCR assays.
In a Community Testing Study, where the Lucira test was compared to the Hologic Panther Fusion, 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.
Limit of detection (LOD) is one of the most important measures underlying a test’s performance. It is a measure of the lowest level of virus whereby the test will detect a positive result. Lucira's LOD is among the best FDA EUA molecular tests which have a limit of detection of 1,000 copies/ml VTM (shown at right in green). These high sensitivity molecular tests achieve their low LOD by amplifying the viral target. Antigen tests (shown at right in red) do not amplify the viral target and require significantly higher levels of virus in a collected sample to detect a positive. As a result, they are less likely to detect a positive result at low viral loads as compared to high sensitivity molecular tests like Lucira.
¹ La Scola B., Clinical Infectious Diseases, September 2020
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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.