The QuickVue At-Home OTC COVID-19 Test offers rapid results without the need to send samples out to the lab. This test is available over-the-counter and includes everything needed.
This home test is authorized for non-prescription 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. The test to be used in individuals within 6-days of symptom onset or individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The Quickvue At-Home OTC COVID-19 test can accurately detect the Omicron variant (among others) of the Sars-CoV-2, the potentially deadly virus that can lead to COVID-19.
Quidel is a California-based leading diagnostic manufacturer focused on improving the quality of healthcare throughout the globe. As a trusted innovator in the medical device industry for over 40 years, Quidel launched the QuickVue brand in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test cleared by the FDA for professional use.
Now, the QuickVue At-Home OTC COVID-19 Test utilizes trusted technology used for decades by healthcare professionals and makes simple, easy-to-use COVID-19 tests accessible for the good of our families, our communities and the world.
QuickVue At-Home OTC COVID-19 Test Features:
- FDA Emergency Use Authorized test
- Intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals within 6-days of symptom onset or individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests
- Self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 or nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19
- Contents: Swabs – (25) Individually wrapped sterile foam swabs, (25) Test Strips, (25) Pre-filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals
This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA) 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.
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