The Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS‑CoV-2, influenza A, and influenza B protein antigens.

This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

No, you do not need insurance to use this test. The Flowflex Plus COVID-19 and Flu A/B Home Test is for over-the-counter (OTC) use.

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

There are different kinds of tests for the viruses that cause COVID-19 and the flu. Molecular tests detect genetic material from the virus. Antigen tests, such as the Flowflex Plus COVID-19 and Flu A/B Home 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.

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.

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 I 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 Warnings and Result Interpretation sections for more information).

Potential benefits include:

• The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.
• The results of this test may help limit the spread of COVID-19 and flu to the family of the tested individual 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.

No, the Flowflex Plus COVID-19 and Flu A/B Home Test is a single use test and cannot be reused.

The CPT Code for COVID-19 is: 87811QW

• Short Descriptor: SARS-COV-2 COVID19 W/OPTIC
• Medium Descriptor: IAADIADOO SEVERE AQT RESPIR SYND CORONAVIRUS
• Long Descriptor: Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

The CPT code for Flu A is: 87804QW

• Descriptor: INFECTIOUS AGENT ANTIGEN DETECTION BY IMMUNOASSAY WITH DIRECT OPTICAL (IE, VISUAL) OBSERVATION; INFLUENZA
• QW: CLIA WAIVED TEST

The CPT code for Flu B is: 87804QW-59

• Descriptor: INFECTIOUS AGENT ANTIGEN DETECTION BY IMMUNOASSAY WITH DIRECT OPTICAL (IE, VISUAL) OBSERVATION; INFLUENZA
• QW – 59: CLIA WAIVED TEST, INFLUENZA B

The CPT code for COVID-19 and Flu A/B is: 87428

• Short Descriptor: SARSCOV & INF VIR A&B AG IA
• Medium Descriptor: IAAD IA SARSCOV & INFLUENZA VIRUS TYPES A&B
• Long Descriptor: Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA] qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B.

The Flowflex Plus COVID-19 and Flu A/B Home Test NDC codes are provided below:

The LOINC code is: 97099-6

• Description: Influenza virus A and B and SARS-CoV-2 (COVID-19) Ag panel – Upper respiratory specimen by Rapid immunoassay.

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.