The Lucira Check It COVID-19 Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for over-the-counter (OTC) use with self-collected nasal swab samples in individuals with or without COVID-19 symptoms aged 14 and older, and in children aged 2-13 collected by an adult. This test is similar to a PCR test in that it utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.
Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Negative results are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary, for patient management may be performed.
For use under the Food and Drug Administration’s Emergency Use Authorization only.
Test results can be reported through the LUCI secure portal, to relevant public health authorities in accordance with local, state, and federal requirements.