![]() Kit is only authorized for the duration of the declaration that circumstances exist justifying theĪuthorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Sectionĥ64(b)(1) of the Act, 21 U.S.C. This home test kit has been authorized only for the testing of nasal swabs forĭetection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home test kit has been authorized byįDA under EUA. This home test kit has not been FDA cleared or approved. Test results can be reported through the LUCI secure portal, to relevant public health authorities in accordance with local, state, and federal requirements. Negative results are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary, for patient management may be performed.įor use under the Food and Drug Administration’s Emergency Use Authorization only. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. Negative results do not preclude SARS-CoV-2 infection. Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results are indicative of the presence of SARS-CoV-2. ![]() This test is similar to a PCR test in that it utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA. 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. 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.
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