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.

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.

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).

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

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.

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

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-
updates/coronavirus-disease-2019-testing-basics

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

We are continuously monitoring the arrival of new COVID-19 variants, and we promptly evaluate our test’s performance against any new variants, as clinical samples containing the new variants become available to us.

This process takes time, but as soon as the results are in, we issue a Press Release on our website to keep consumers informed in a timely manner.

Please check the website for updates at flowflexcovid.com in the news section towards the bottom of the page.

Alternatively, www.aconlabs.com in the News/Tradeshow section.

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.

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.

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.

AZOVA is authorized to offer proctoring services for travel purposes in conjunction with ACON’s Flowflex Antigen Home test.

For more details, go to www.azova.com/flowflexvideo before performing your test, or call (844) 692–9682.

There is an additional cost associated with the proctoring services provided by AZOVA.

We also recommend you visit the CDC, the TSA, and your airline carrier websites, to view the latest documentation and accepted testing requirements for your destination.

We do not currently offer proctoring services that would allow you to provide a test result to your employer.

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

Flowflex tests in a blue box are intended only for distribution and use outside the USA, and they do not have FDA Emergency Use Authorization. Please fill out the Contact Us form and provide the Lot number and location where the product was purchased.

The CPT Code is 87426

• Short Descriptor: SARSCOV CORONAVIRUS AG IA
• Medium Descriptor: IAAD IA SEVERE AQT RESPIR SYND CORONAVIRUS
• Long Descriptor: Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19])

The NDC code for the 1-test configuration is 82607-0660-26.

The LOINC code is 97097-0

• Description : SARS-CoV-2 (COVID-19) Ag [Presence] in Upper respiratory specimen by Rapid immunoassay

The test is manufactured by ACON’s FDA registered, state-of-the-art manufacturing facility in China. The manufacturing facility is ISO13485: 2016 certified and inspected by the FDA.

For over 25 years, ACON has continued to supply billions of IVD tests per year Worldwide.

 Yes, it is safe to use. The test is manufactured by ACON’s FDA registered, state-of-the-art manufacturing facility in China. The manufacturing facility is ISO13485: 2016 certified and inspected by the FDA. For over 25 years, ACON has continued to supply billions of IVD tests per year Worldwide.

The tip of the nasal swab made of polyurethane foam and, is sterile and safe to use. The swab is sterilized using Ethylene Oxide before aeration to remove any residual components. After the aeration process, no chemicals should be left on the swabs.

Future shelf-life expiration date extensions will be communicated as they become available.

If you have questions, please contact customer support at 1 (800) 838 9502.