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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.

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 (NPA)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 PCR 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

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.

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.

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.

We developed LUCI PASS as a way to provide you a free, digital verified Lucira test result on your phone.  Using LUCI is simple and doesn’t require you to download an app.

To get started simply text the word “LUCI” to 44544.  You will receive a text back with a link to submit your test results.  Simply follow the prompts on your phone to create your LUCI account and submit your results.  LUCI uses your phone’s camera to digitally verify your test result.  As soon as your results are submitted, you will receive your LUCI PASS.

You can view previously submitted tests by texting “Results” to 44544 or visiting luci.lucirahealth.com.

Have trouble accessing our 44544 text code? You may also access LUCI by going to luci.lucirahealth.com from your smartphone.

Your phone’s camera isn’t activating? Make sure your phone’s browser has permission to access the camera.

If you need further assistance, please contact our support line at 1-888-582-4724.

Where can I find Lucira COVID-19 Test Kits?

Lucira is available to purchase in the United States directly from our website. Visit our online store for healthcare providers or for consumers.

Additionally, Lucira is authorized for sale in Canada, Puerto Rico, Singapore and Taiwan. For international sales interest, please contact Sales.

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, Lucira detects the alpha, beta, delta, gamma, lambda and mu COVID-19 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 12-month shelf life. Read our Notice of Shelf Life Extension for more information.

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. 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.

How do I share my LUCI results?

Your LUCI PASS is stored in your LUCI account for 7 days and is accessed by texting “RESULTS” to 44544 from a US phone number or by logging into luci.lucirahealth.com.

You can also download and email a PDF version of your LUCI PASS. Once downloaded, you can print the PDF.

How long is my LUCI PASS good for?

Your LUCI PASS lasts for 7 days and then will be cleared from your account. Check the requirements for where you plan to use your LUCI PASS, as many partners require test results within 48 or 72 hours (2-3 days).

What does LUCI PASS display?

Your LUCI PASS will display:

  • Your name, date of birth and optional selfie
  • Your verified test result, including the test results date and time
  • Test accuracy, clinical performance and ability to detect COVID-19 variants
  • A link to Lucira’s FDA Emergency Use Authorization (EUA)

How does LUCI PASS work for travel?

Always check with your airline for details and restrictions on using your Lucira test results for travel to your destination. Restrictions vary between destinations.

When an airline requests proof of a negative COVID-19 test result, it’s usually best to download your LUCI PASS as a PDF and upload the PDF to the airline website. Once downloaded, you can print a hard copy of the PDF and bring it with you, in addition to displaying LUCI PASS on your smartphone at the airport.

Note that for travel to Hawaii, Lucira is now available through AZOVA’s Hawaii Travel Program.

How do I share my Lucira test results with my airline?

Always check with your airline for details on sharing your test results. Each airline has different requirements and we recommend downloading your LUCI PASS as a PDF file and then uploading that PDF file to the airline’s website.

You can also print a hard copy of the downloaded PDF and bring it with you to the airport, in addition to displaying LUCI PASS on your smartphone at the airport.

Can I use LUCI with the Lucira COVID-19 All-In-One (prescription) Test Kit?

Yes, you can obtain a LUCI PASS if your healthcare provider prescribes you the Lucira COVID-19 All-In-One Test. You will need the test kit box and your resulted device. Public health reporting is still the healthcare provider's responsibility even if the patient uses LUCI.

Will my personal or health information be shared?

LUCI can optionally transmit your test result to your state's public health authority. This is optional. Your test results are deleted from the LUCI system after 7 days. Lucira will not share your personal or health information without your express consent.

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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