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The COVID-19 PCR quality at-home test you can trust

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Lucira is the first and only FDA EUA authorized single-use molecular test available over-the-counter. Get results at home in 30 minutes or less.

For FDA Emergency Use Authorization (EUA) Only. For Over-The-Counter Use. For In Vitro Diagnostic (IVD) Use.

Lucira CheckIt - 98% Accurate

Lucira’s technology has been in development for over 5 years.
The moment for accurate at-home PCR quality molecular accuracy is now.

90 %
Accurate1
80 %
Positive Percent Agreement (PPA)1
80 %
Negative Percent Agreement (PPA)1
The Lucira Check It COVID-19 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 some of the best molecular tests performed in clinical settings and high complexity labs. If SARS-CoV-2 is present in a sample, Lucira amplifies the virus’s genetic material while the test is running just like PCR lab tests. In the clinical studies described below, Lucira’s amplification method provides a level of accuracy comparable to one of the highest sensitivity lab PCR tests.
In two Community Testing Studies which included individuals with and without COVID-19 symptoms, the Lucira test was compared to the Hologic Panther Fusion, one of the highest sensitivity FDA authorized SARS-CoV-2 PCR tests. Lucira achieved 98% accuracy, 97% positive percent agreement (PPA) and 98% negative percent agreement (NPA)3, excluding samples with very low levels of virus that possibly no longer reflected active infection4. Across all data, and including 10 samples with very low viral loads (>37.5 Ct), Lucira achieved 96% accuracy, 92% PPA, and 98% NPA3.
 
Wondering what PPA and NPA are? In our studies, participants would swab themselves twice—for the Lucira test and a known high sensitivity PCR test. Then, we compared the Lucira test results to the PCR test results. Positive Percent Agreement (PPA), or sensitivity, represents how often the Lucira test agreed with the comparator PCR’s positive test results. Negative Percent Agreement (NPA), or specificity, represents how often the Lucira test agreed with the comparator PCR’s negative test results.
Lucira Community Testing Study Positive Percent Agreement (PPA) Summary
The above graph shows the Lucira Check It COVID-19 Test Kit positive percent agreement in Lucira’s two Community Testing Studies. BLUE bars represent samples where the Lucira positive test result matched the comparison test result. GREY bars represent the Lucira test results that were negative and did not match the comparison test positive result. Nearly all of the GREY bars occurred in samples where there were very low levels of virus detected by the comparison test.

The Lucira Check It COVID-19 test kit has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA.
  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)
  4. La Scola B., Clinical Infectious Diseases, September 2020

Live your life without worrying about COVID-19.

Fast, accurate, at-home results mean you can now test whenever you need to. And Lucira Check It is suitable for the whole family, with adults administering the test for children ages 2-13.

Results you can trust whether you have symptoms or not.

Lucira is clinically proven to have PCR quality molecular accuracy. In multiple clinical studies that included individuals with and without COVID-19 symptoms, Lucira achieved 98% accuracy when compared to one of the best FDA authorized known high sensitivity PCR tests1.

Verify and report your Lucira COVID-19 test results with LUCI PASS™.

We created the LUCI PASS™ to make it easy for you to receive a free, verified Lucira test result. After taking our test, you simply text to access our secure LUCI portal, and then follow a few steps to submit your results. You will receive a free LUCI PASS with your verified test results back on your phone. No app is required. LUCI also transmits your result to the relevant public health authorities. LUCI was developed to support our over-the-counter test kit.

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 SARS-CoV-2 which causes COVID-19. The test detects if you have an active infection and does not confirm immunity or detect antibodies. It is a molecular test that amplifies the virus’s genetic material while the test is running just like PCR lab tests. Lucira’s amplification method provides a level of accuracy comparable to one of the highest sensitivity lab PCR tests.

Can this test detect new SARS-CoV-2 variants?
Yes, it detects the B.1.1.7 (UK), B.1.351 (South Africa), P.1 (Brazil), and B.1.427/B.1.429 (Southern California) SARS-CoV-2 variants. Lucira Health performs routine surveillance of emerging SARS-CoV-2 strains and will continue to monitor the situation with emerging variants. We keep a Technical Brief on our website that lists the new strains we believe our test is reactive to.

How many times can I use this test?
Each test kit is single-use and comes with everything needed to run 1 Covid-19 test.

What’s the shelf life?
Currently, the test kit has a 6-month expiration. Note the FDA only allows COVID test product expiration dating to be supported by real time aging studies. We have continued real time aging studies underway and expect to update our expiration dating every three months. The next time we expect to update our expiration dating is in late May 2021.

Will this test hurt?
No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly.

What if I have questions about how to use this test when it arrives?
Each kit comes with instructions inside of it. You can see those instructions here, too. It’s important to carefully read and follow the instructions for the test to work properly. We also provide a video demonstration on our website.

What are the known potential risks and benefits of this test?
Potential risks include:

  • Possible discomfort during sample collection
  • Possible incorrect test results

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and others in your community.

What’s an invalid result?
An invalid result means something with the test did not work properly. The chance of getting an invalid result is low, 2%. If the test result is invalid, all the lights on the device will be blinking. If your test shows an invalid result, please contact us at 1-888-582-4724. We will assist you and provide you a replacement test free of charge.

If I have other questions, how do I contact Lucira?
We're here for you. You can call Customer Service at 1-888-582-4724 or email us at info@lucirahealth.com.

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 declaration is terminated or revoked sooner.

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