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:

• 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.

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.

There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the QuickVue At-Home OTC COVID-19 Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection.

The type of testing and documentation required for air travel may differ based on travel destination, airline, and state/country requirements. We encourage you to visit the CDC/TSA website as well as the airport, airline, and health department’s website for the latest requirements on the type of acceptable testing and documentation for your travel destination.

At QuidelOrtho, we continuously monitor the evolution and activity of COVID-19 variants in circulation and will continue to be vigilant in evaluating our tests with real-world virus samples to assure you of our product’s efficacy. QuidelOrtho has completed testing on several variant strains and the test was able to detect the mutations. Because the test detects a part of the virus that is less susceptible to mutation, the likelihood of detecting new or emerging variants is high. QuidelOrtho monitors the variants closely and will inform the FDA promptly, should any issues be detected.