Please visit the Say Yes! COVID Test website for more information. The FAQ can be found here.
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.
You do not need a doctor’s prescription to purchase and perform this 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.
Individuals with or without symptoms can still utilize this test, as needed, regardless of vaccination status.
The test kit comes with two tests intended to be used for the same patient. A 25-test kit is also available.
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).
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.
Potential risks include:
Potential benefits include: