Lucira Check It COVID-19 Test Kit + LUCI PASS

The Lucira Check It COVID-19 Test Kit is a single-use test kit intended for self-collection at-home by individuals 14 and older to detect the virus that causes COVID-19.

Key Features

• FDA/EUA: The Lucira Check It COVID-19 Test Kit is the first and only FDA EUA authorized single-use molecular test. This is a quick PCR-quality molecular test for self-collection of a nasal sample, for use by symptomatic and asymptomatic individuals. The test can run in 30 minutes or less. Results are available within 12 hours of uploading a photo of your test to LUCI PASS.
• CONVENIENT, EASY TO USE – Everything needed for self-collection of nasal sample: Instructions For Use, 1 nasal swab in a peel-pouch, 1 sample vial containing liquid for processing sample, 1 test unit for running test, 2 AA batteries for the test unit, 1 plastic disposal bag. 
• FREE RESULTS REPORT APP – LUCI PASS can report the results of this test to relevant public health authorities in accordance with local, state, and federal requirements.
• PHOTO UPLOAD REQUIREMENT – While you do NOT have to send your sample to a lab to get your result, you DO need to upload a completed photo of your test after it has run in order to receive your results. 
• PCR-QUALITY MOLECULAR ACCURACY: Achieved 97% sensitivity (positive percent agreement) and 98% specificity (negative percent agreement)(1), excluding samples with very low levels of virus that possibly no longer reflected active infection(2). Across all data, achieved 92% sensitivity and 98% specificity(3).
• VIRUS DETECTION ONLY – This test will not confirm immunity or detect antibodies with respect to COVID-19.
• FOR PEOPLE 14 AND OLDER – Self-collection at home is approved for anyone 14 years and older, while people ages 2-13 years require adult collection by a healthcare provider.

1. Excluding 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)

2. Lucira Usability Clinical Study 07A-CLI-004/005 conducted Summer 2020 (n=352)

3. Lucira Community Testing Study 07A-CLI 006 Fall 2020 and Lucira Community Testing Study 07A-CLI 007 Winter 2021 (n=404)

Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here. Feel free to contact us any time with questions at support@meenta.io, and we’d be happy to help you out!

Frequently Asked Questions

Can you tell me more about Lucira’s PCR quality molecular accuracy?

The Lucira Check It COVID-19 Test Kit is a diagnostic test to detect the virus that causes COVID-19. Therefore, the test detects if you have an active infection. However, it does not confirm immunity or detect antibodies. Specifically, it is a molecular test that amplifies the virus’s genetic material while the test is running just like PCR lab tests. Importantly, Lucira’s amplification method provides 98% accuracy compared to one of the highest sensitivity lab PCR tests.

Can this test detect new SARS-CoV-2 variants?

Yes, this Lucira Check It COVID-19 Test Kit has been shown to detect 99% of known COVID-19 variants. Regularly, Lucira Health is doing testing to make sure that this Lucira COVID test can detect emerging strains as well. In the meantime, we keep a Technical Brief that lists the new strains that this test can detect.

What’s the shelf life?

Currently, the test kit has a 12-month expiration. Importantly, the FDA requires real time aging studies for this kind of statement. Therefore, Lucira has real time aging studies underway and expect to update the expiration dating every three months.

How many times can I use this test?

Each Lucira Check It COVID test kit is a single-use and comes with everything needed to run 1 COVID-19 test.

Is this test covered by insurance?

We recommend that you reach out to your insurance carrier directly to discuss reimbursement.

Are there any important documents I should read before taking this test?

While not required, here are a few documents of interest:

• This test is only approved for use under the Food and Drug Administration’s Emergency Use Authorization.
• In addition, if you’re interested in learning the details of all of the variants this Lucira test can detect, you can find more information here.
• Also, the extended instructions for using the Lucira Check It COVID-19 test could be useful.
• However, if you still have more questions, there is an extended FAQ document from Lucira here.

How do I interpret my test results?

It is very likely you have COVID-19 and it is important to be under the care of a healthcare provider. It is likely you will be asked to isolate yourself at home to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive). Your healthcare provider will work with you to determine how best to care for you based on your test results along with your medical history and your symptoms.

A negative result means the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result with all other aspects of your history such as symptoms and possible exposures to decide how to care for you. It is important you work with your healthcare provider to help you understand the next steps you should take.