Lucira provides molecular lab quality results in 30 minutes or less.
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-collecting 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 in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider.
- Molecular lab quality results in 30 minutes or less
- Accuracy equivalent to high sensitivity PCR—achieved 100% sensitivity (positive percent agreement) up to a 37.5 Ct value versus the Hologic Panther Fusion, one of the highest sensitivity RT-PCR assays1
- Achieved 98% specificity (negative percent agreement) in clinical testing1
- Able to identify Alpha, Beta, Delta, Gamma, and Lambda, and B.1.621 variants (see technical brief below)
- Easy to use nasal swab specimen
- 100% of users 14 years and older were able to run the test2
1Lucira Community Testing Study 07A-CLI 006 Fall 2020 (n=101)
2Lucira Usability Study 07A-CLI 004/005 Summer 2020 (n=352)
- Lucira COVID-19 Test Kit FDA EUA Letter
- Lucira COVID-19 Test Kit Insert (PI)
- Lucira COVID-19 Test Kit Healthcare Provider Instructions For Use (IFU)
- Lucira COVID-19 Test Kit Healthcare Provider Fact Sheet
- Lucira COVID-19 Test Kit Healthcare Provider Reporting Guidance
- Lucira COVID-19 Test Kit Emerging SARS-CoV-2 Strains