QuickVue At-Home COVID-19 Test, 3 Packs, 6 Tests Total, Self-Collected Nasal Swab

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.

The QuickVue At-Home OTC COVID-19 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 test does not differentiate between SARS-CoV and SARS-C0V-2.

In the USA, 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.

The easy-to-use at-home COVID-19 testing kit provides results in just 10 minutes. The non-invasive design makes it easy to gently swab your nose, place in pre-filled tube, and quickly get rapid test results. The test is FDA Emergency Use Authorized and FSA/HSA eligible.

The home COVID-19 test is quick, simple, and designed for self-collected nasal swabs for ages 14 or older. Ages 2+ can be tested if an adult collects the sample. The test provides straightforward results with a pink or blue line on the test strip.

The at-home COVID-19 screening is for those with or without symptoms and takes approximately 10 minutes. This listing is for a single test kit. The test kit does not provide a document to present for certain uses, including air travel, re-entry requirements, or testing programs. Please check the requirements for your specific testing needs.

Each kit includes: 2 individually wrapped sterile foam swabs in order to test twice over 3 days with at least 24 hours (and no more than 48 hours) between tests, pre-filled tubes (no measuring/counting drops), tube holder, instruction sheet, and patient fact sheets.

Take your test and lose the stress with QVue, the QuickVue companion app that makes your testing experience easier than ever. Download QVue from your app store.

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