About This Test

Flowflex COVID-19 Antigen Home Test

Where can I buy this product?

Click here to view our growing list of retailers.

How many tests come with the test package?

This test is available in 1-test, 2-test, 5-test and 25-test packages.

What is this test?

The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only.

How does this test work?

This test uses a nasal swab sample to determine the presence or absence of COVID-19 antigens in nasal samples. For a demonstration on how this test works, watch the instructional video.

What is the age range for this 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.

What is EUA? How does that affect this test?

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 Services’ (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).

Do I need insurance to use this test?

No, you do not need insurance to use this test. The Flowflex COVID-19 Antigen Home Test is for over-the-counter (OTC) use.

Do I need a prescription to use this test?

No, you do not need a prescription to use this test. The Flowflex COVID-19 Antigen Home Test is for over-the-counter (OTC) use.

Can people who are vaccinated use this test?

Yes, individuals with or without symptoms can use this test regardless of vaccination status.

Can I use this test if I do not have COVID-19 symptoms?

Yes, individuals with or without symptoms can use this test regardless of vaccination status.

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 Result Interpretation section).

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

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 your healthcare provider.

What is the difference between Antigen, Molecular, and Antibody tests?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as the Flowflex COVID-19 Antigen Home Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 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. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home.

Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been produced by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable for diagnosing an active COVID-19 infection.

For more information on the different kinds of COVID-19 tests, please visit: https://www.fda.gov/consumers/consumer-

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

The type of testing and documentation required for international/air travel may be different based on the travel destination, airline, and state requirements. Therefore, we recommend that you contact your airline carrier, visit the CDC/TSA website, and your local health department’s website for the latest requirements on the type of acceptable testing and documentation for your travel destination.

Is this test reusable?

No, the Flowflex COVID-19 Antigen Home Test is a single use test and cannot be reused.