How does the QuickVue COVID-19 Test work? - QuickVue At-Home

How does the QuickVue COVID-19 Test work?

The test uses a gentle nasal swab sample 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 ten minutes, you can take the strip out of the tube and see your results.

For a demonstration on how the test works, watch the instructional video:

QuickVue At-Home COVID-19 OTC Test – User Instructions video
General steps for conducting the test are:
4 simple steps to administer the test: Step 1. Swab. Step 2. Swirl. Step 3. Dip. Step 4. Results.

Step 1. Gently swirl nasal swab four times in each nostril

Step 2. Place nasal swab in the solution tube, twist 3-4 times, and remove the swab

Step 3. Place test strip into the tube

Step 4. Easy-to-read results are available in just 10 minutes

Before you begin the test, it’s important to first read and closely follow the detailed user instructions included in the package.

Our QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance by the U.S. FDA under a new name – QuickVue COVID 19-Test.

The QuickVue 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 COVID-19 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.

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