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.

What Apps work with the QuickVue At-Home OTC COVID-19 Test?

The QuickVue At-Home OTC COVID-19 Test does not require an App for use. The kit provides immediate actionable results without the use of an App. A QVue™ Business App is available for use by employers that administer COVID-19 testing programs to employees. To learn more, provide us your information at quidel.com/covid-19.

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.