The QuickVue At-Home OTC COVID-19 Test is fast, simple, and easy-to-use designed with at-home users in mind. Intended to be used twice over 2 to 3 days with at least 24 hours – no more than 36 hours – between tests, the test uses a gentle nasal swab sample to determine a positive or negative COVID-19 test result. The swab is swirled in a tube of reagent solution, then removed before a test strip is inserted. After 10 minutes, take the strip out of the tube to see your results.
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Disclaimer
The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The QuickVue At-Home OTC COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.
In the U.S., this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
