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.

Is this test eligible for Flexible Spending Accounts (FSAs)?
Yes, this test is an eligible expense that can be reimbursed under FSAs.
Can people who are vaccinated use this test?

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

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

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.

Does the Flowflex COVID test work for new variants?

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.

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.

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.

Do you offer proctoring services with this test to travel/to travel abroad/for international travel/to travel back to the US ?

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.

Do you offer proctoring services and results with this test that I could provide my work?

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

Is this test reusable?

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

Why did my Flowflex test come in a blue box instead of a white box?

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.

What is the Flowflex CPT code to bill insurance?

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])
What is the Flowflex NDC code?

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

What is the Flowflex LOINC code?

The LOINC code is 97097-0

  • Description : SARS-CoV-2 (COVID-19) Ag [Presence] in Upper respiratory specimen by Rapid immunoassay
Where is the Flowflex COVID-19 Antigen Home Test manufactured?

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 Flowflex COVID-19 Antigen Home Test is manufactured in China is it safe to use?

 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.

Nasal Swab questions – what is it made of, is it sterile, how is it sterilized, are chemical residues on the swab?

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.

What is the new shelf life of the Flowflex COVID-19 Antigen Home Test?

On September 2, 2022 the FDA granted ACON Laboratories, Inc. a shelf life extension from 12 months to 19 months, for its Flowflex COVID-19 Antigen Home Test, when stored at 36-86°F (2-30°C). Refer to the table for the new expiration date using the lot number printed on the test kit box.

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