Description
QuickVue At-Home over-the-counter Covid-19 test lets you get rapid results conveniently in the comfort and privacy of your own home. Test as often as you need to, wherever you would like. The test is intended to be used twice over 2 - 3 days with at least 24 hours, and no more than 36 hours, between tests. There are two tests in each box. The test uses a gentle, self-collected anterior nasal swab to determine a positive or negative Covid-19 result. The swab is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After 10 minutes, you can take the strip out of the tube and see your results. The QuickVue At-Home OTC Covid-19 test detects proteins from the virus.
- The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.
- For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal(NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older
- Positive results indicate the presence of viral agents, 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 viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
- Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
- The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated