The Lucira COVID-19 & Flu Home Test is a single use (disposable) home test kit intended for simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection, including COVID-19.
The Lucira COVID-19 & Flu Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
This Lucira COVID-19 & Flu Home Test contains everything needed to perform one (1) Lucira COVID-19 & Flu Home Test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.
The Lucira COVID-19 & Flu Home Test is a single use (disposable) home test kit intended for simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection, including COVID-19. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
The Lucira COVID-19 & Flu Home Test is intended for use in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A, and influenza B viral nucleic acid is generally detectable in anterior nasal swab samples during the acute phase of infection.
Positive results indicate the presence of viral nucleic acid, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease. Individuals who test positive with the Lucira COVID-19 & Flu Home Test should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary.
Negative results for SARS-CoV-2 and influenza B are presumptive, meaning that they should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests.
Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for treatment or other management decisions, including infection control decisions. Negative results should be considered in the context of current prevalence of infection, an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with respiratory infection.
Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow up care with their healthcare provider.
Individuals should report all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS- CoV-2 Tests provided by CDC.
The Lucira COVID-19 & Flu Home Test is authorized for non-prescription self-use by individuals aged 14 years or older and/or, as applicable, for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The Lucira COVID-19 & Flu Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
EUA Disclaimer: Lucira COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA). It has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. This authorization is for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 authorization is revoked sooner.