Lucira Check It COVID-19 Test Kit
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Lucira Check It provides PCR quality molecular accuracy in 30 minutes or less. Meet the COVID-19 test you can trust for whenever you need it.
- First and only FDA EUA authorized single-use molecular home test
- 98% accurate compared to one of the best known high sensitivity lab PCR tests1
- Results in as fast as 11 minutes for a positive result and 30 minutes for a negative result
- Authorized for self-collection for individuals aged 14+ and adult collection for children aged 2-13
- 100% of people 14 and older were able to run our test2
- Detect alpha, beta, delta, gamma, lambda, mu and omicron COVID-19 variants
1Excluding samples with very low levels of virus (>37.5 Ct), Lucira Community Testing Study 07A-CLI 006 Fall 2020 and Lucira Community Testing Study 07A-CLI 007 Winter 2021 (n=394)
2Lucira Usability Study 07A-CLI 004/005 Summer 2020 (n=352)
The Lucira Check It COVID-19 Test Kit has not been FDA cleared or approved, but has been authorized for emergency use under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Indication 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.