Lucira COVID-19 All-In-One Test Kit

Description

• The Lucira COVID-19 All-In-One Test Kit is a single-use molecular 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 testing 1 Detects alpha, beta, delta, gamma, lambda, mu and omicron COVID-19 variants 2 Easy-to-use nasal swab specimen 100% of users 14 years and older were able to run the test 3 1
• Lucira Community Testing Study 07A-CLI 006 Fall 2020 (n=101) 2
• Visit the Lucira Health website and go to Technical Brief for more information
• 3
• Lucira Usability Study 07A-CLI 004/005 Summer 2020 (n=352)