About the Test - QuickVue At-Home - Page 3

What is the QuickVue COVID-19 Test?*

The QuickVue COVID-19 Test is a type of test called a rapid antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19, in anterior nasal swabs.

What is the age range for the test?

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.

How accurate is the test?

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU).

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.

Will this test hurt?

No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.

Where can I purchase the QuickVue COVID-19 Test?

View our list of approved retailers listed below.

  • Amazon.com logo
  • CVS Pharmacy logo
  • Health Mart Pharmacy logo
  • MedSavers Pharmacy logo
  • Simply Medical logo
  • Walmart.com logo

How long does it take to get results?

Results are available in as little as 10 minutes in the privacy of your own home.

Will the test work if I don’t have symptoms?

The test is intended for the individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.

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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