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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).
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)
These home tests have not been FDA cleared or approved. These home tests have been authorized by FDA under Emergency Use Authorization (EUA). These home tests have been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2 alone, or from SARS-CoV-2, influenza A, and influenza B; not for any other viruses or pathogens. These home tests are 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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