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Comparing Our Revolutionary
Testing Kit to the Best PCR Tests

Lucira’s Molecular COVID-19 Testing Studies

The Lucira Check It is a molecular or nucleic acid amplification test (NAAT) that provides accurate, at-home results for the detection of the COVID-19 virus. Our tests have an analytical sensitivity (ability to detect the SARS-CoV-2 virus) that is comparable to some of the best performing PCR tests in clinical settings and high complexity labs.
 
To ensure the validity and accuracy of Lucira’s COVID-19 Test Kit, several studies were conducted to compare our tests against one of the most sensitive PCR tests authorized by the FDA.

Lucira: Powered by Amplification

If SARS-CoV-2 is present in a sample, Lucira’s innovative platform is designed to find it and amplify 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 COVID-19 test was compared to the Hologic Panther Fusion, one of the highest sensitivity FDA authorized SARS-CoV-2 PCR tests.

Results of Lucira’s COVID-19 Testing Studies

Lucira achieved 98% accuracy, 97% positive percent agreement (PPA) and 98% negative percent agreement (NPA)1, excluding samples with very low levels of virus that possibly no longer reflected active infection2. Across all data and including 10 samples with very low viral loads (>37.5 Ct), Lucira achieved 96% accuracy, 92% PPA, and 98% NPA3.

PPA and NPA Explained

To further validate the results of Lucira’s COVID-19 test kit, study participants swabbed themselves twice—once for the Lucira test and again for a well-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 Device
Lucira Community Test Results - Summary Chart PPA

Lucira Community Testing Study Summary

The 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.

 

 

SOURCES:

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

Order At-Home COVID-19 Test Kits

Start testing and stop worrying with Lucira’s Check It COVID-19 Testing Kit. From the comfort of your home, the results you need are just a swab away.
 
Lucira COVID-19 Test Kits are available for both consumer purchase, as well as for enterprise. In just 30 minutes, our easy-to-use tests give you the results you need so you can make informed decisions.
 
Click the links below to order accurate, at-home molecular COVID-19 test kits.
Small boy having a rapid COVID-19 test at home during coronavirus pandemic. Mother takes a cotton swab coronavirus test from child nose to analyse if postitve for covid-19.

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.

 

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. La Scola B., Clinical Infectious Diseases, September 2020
3. Lucira Community Testing Study 07A-CLI 006 Fall 2020 and Lucira Community Testing Study 07A-CLI 007 Winter 2021 (n=404)