About the Test - QuickVue At-Home

Where can I get information about the Say Yes! COVID Test campaign?

Please visit the Say Yes! COVID Test website for more information. The FAQ can be found here.

Is a prescription required to perform this test?

You do not need a doctor’s prescription to purchase and perform this test.

How long should I wait between the first and second test?

The QuickVue At-Home OTC COVID-19 Test is intended to be used for serial testing or used twice by the same individual over two or three days with at least 24 hours (and no more than 48 hours) hours between tests.

Should people who are vaccinated use this test?

Individuals with or without symptoms can still utilize this test, as needed, regardless of vaccination status.

How many tests come in a kit?

The test kit comes with two tests intended to be used for the same patient. A 25-test kit is also available.

What is Emergency Use Authorization (EUA)?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

What is serial testing?

COVID-19 serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.

What are the known and potential risks and benefits of this test?

Potential risks include:

  • Possible discomfort during sample collection.
  • Possible incorrect test results (see Results section).

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and others in your community.

Is the solution in the tube harmful?

The solution in the tube contains small amounts of hazardous ingredients (see table on page 5 of the User Instructions here). If the solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice at https://www.poison.org/contact-us or 1.800.222.1222.

What is the difference between an antigen test and PCR or molecular tests?

An antigen test, such as the QuickVue At-Home OTC COVID-19 Test, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, but not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider on whether an additional test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19.

The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. 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.

*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.

Partners of:

  • San Diego Padres logo
    San Diego Padres
  • San Diego Loyal logo
    San Diego Loyal
  • Chicago Blackhawks logo
    Chicago Blackhawks
  • New York Jets logo
    New York Jets
  • Los Angeles Rams logo
    Los Angeles Rams