QuickVue At-Home OTC COVID-19 Test Kit, 2 CT

What is the QuickVue At-Home OTC COVID-19 Test?

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

How does the QuickVue At-Home OTC 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: https://quickvueathome.com/#video_testkit-2

Before you begin the test, it's important to first read and closely follow the detailed user instructions included in the package

How long does it take to get results?

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

How many times should I use this test?

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. You may need to purchase additional tests to perform this serial (repeat) testing.

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.

If I see pink shading on the strip bordering the black label, is this a positive result?

Only a pink line about half of a centimeter below the blue control line should be considered a positive result. A pink line bordering the black label with the arrows, a vertical pink line, or a faint grey line next to the blue control line is not considered a positive test line and should not be called a positive result.

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.

What do I do if I test positive?

Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Is this test acceptable for travel? Can it be used for proof of a negative COVID-19 test?

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

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.

What are the differences between antigen tests and other COVID-19 tests?

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.

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

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.

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

Potential risks include:

• Possible discomfort during sample
• 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

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) 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).

How many tests come in a kit?

The test kit comes with two tests intended to be used for the same patient.

Should people who are vaccinated use this test?

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

If I am positive after the first test, do I have to take another test?

If you test positive with the QuickVue At-Home COVID-19 Test you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.

Is this test covered by insurance?

The test is available for at-home use without a prescription. Please consult with your specific health insurance to make sure your test will be covered.

Is a prescription required to perform this test?

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

What does it mean if I have a positive test result?

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self isolate from others and contact a healthcare provider for medical advice about your positive result.

What does it mean if I have a negative test result?

A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms and received a negative result, you should test at least two more times with 48 hours in between tests for a total of three tests. If you have a negative result, it does not rule out SARSCoV-2 infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take.

What does it mean if I have an Invalid Test result?

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.

Will this test detect COVID-19 variants?

At Quidel, 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. Quidel 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. Quidel monitors the variants closely and will inform the FDA promptly, should any issues be detected.

Where is the test made?

The test is made in San Diego, California.

Why are the instructions in my test kit different than the instructions on the website? Which one do I use?

Quidel recently updated the kit instructions to clarify the best timeframe to use the test. Please refer to the User Instructions on Quidel.com for the most up-to-date instructions.

Where can I find the kit expiration date?

The expiration date is labeled on the outside of the kit box, under the lot number, next to the hourglass symbol. There is also a date printed next to the symbol of a building with a chimney and this is the date of manufacture.

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