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About This Test

Flowflex® Plus COVID-19 + Flu A/B Home Test

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

The Flowflex Plus COVID-19 + 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.

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

Yes, this test is an eligible expense that can be reimbursed under FSAs.

Yes, individuals who are vaccinated can use this test.

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 + 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 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 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 + Flu A/B Home Test is a single use test and cannot be reused.

The CPT code for COVID-19 and Flu A/B is: 87812 QW

  • Description: Infectious agent antigen detection by immunoassay with direct optical (visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza virus types A and B.
  • Modifier QW: Indicates a CLIA-waived test.
The Flowflex Plus COVID-19 and Flu A/B Home Test NDC codes are provided below:  
Kit Configuration UPC NDC
1T 810107290019 10107-0290-01
2T 810107290026 10107-0290-02
5T 810107290033 10107-0290-03
25T 810107290040 10107-0290-04

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.

Using This Test

Flowflex® Plus COVID-19 + Flu A/B Home Test

Please refer to the Quick Reference Instructions on how to use this test.

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.

Do not use this test on children under two years of age. Do not use this test on anyone who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.

Yes, individuals who are vaccinated can use this test.

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.

Insert the swab ½ to ¾ inches inside your nostril. With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have a second person hold the child’s head while swabbing. Note: A false-negative result may occur if the nasal swab specimen is not properly collected.

Please use the swab to collect specimen from both of your nostrils to ensure sufficient sample collection to generate an accurate result.

Firmly rub the swab in a circular motion around the inside wall of the nostril 5 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present onto the swab. Repeat this in the other nostril.

The solution should be clear and colorless. If you receive a solution that has a yellow color, do not use this test kit. Please contact customer service at (800) 838-9502 for assistance. Customer Service hours are 8 a.m. – 8 p.m. (EST), 7 days a week.

Place the swab into the buffer tube and swirl for 30 seconds. Rotate the swab 5 times while squeezing the tube. Remove the swab while squeezing the tube to extract as much liquid as possible. Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube. Then gently squeeze the tube and dispense 4 drops of solution into the Sample Well.

You should dispense 4 drops of the solution into the cassette Sample Well.  Please do not overuse the buffer solution.

You should dispense 4 drops of solution into the cassette Sample Well marked with an “S”.

If the little tube contains approximately 0.28 inch or 7 mm of buffer solution or more, there is enough buffer solution to perform the test.

Yes, discoloration of the swab tip is normal and due to UV exposure. The swab is safe to use and will have no impact on test performance.

If the little tube contains approximately 0.28 inch or 7 mm of buffer solution or more, there is enough buffer solution to perform the test, even if the entire swab tip is not covered.

If you were able to apply 4 drops of liquid unto the test cassette sample well marked “S”, and you followed all the instructions on the product insert, then it is fine. The entire swab tip does not need to be covered.

For the test to provide an accurate result, you must apply 4 drops of liquid unto the test cassette sample well, the one marked with an “S”. If your tube contained only enough liquid for 3 drops, you must repeat the test with a new cassette and a newly collected specimen sample.

Results and Accuracy

Flowflex® Plus COVID-19 + Flu A/B Home Test

Please refer to the Quick Reference Instructions on how to use this test.

If the control (Ctl) line is visible and any other line or multiple lines, no matter how faint, at “CoV”, “A” and/or “B” appear, the test is positive for that virus. Please refer to the Quick Reference Instructions for more information.

The COVID-19, Flu A and/or Flu B virus(es) were detected in your sample. It is very likely that you have the respective infection(s) and are contagious. Please contact your healthcare provider or your local authorities and follow local guidelines for self-isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive).
If the Control (Ctl) line is visible, but the Test (CoV/A/B) line is not visible, the test is negative. The COVID-19, Flu A, or Flu B virus have not been detected. To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours after the first day of testing. If respiratory symptoms persist, seek follow-up care with a healthcare provider.
If the Control (Ctl) line is not visible, even if any other line is visible in the result window, the test is not valid. Re-test with a new swab and a new test cassette. If the problem persists, call (800) 838-9502 for assistance.

A false positive is a test result that indicates a person has a specific disease or condition when the person actually does not have the disease or condition. A false-negative test result indicates a person does not have a specific disease or condition when the person actually does have the disease or condition. Incorrect specimen collection and sample preparation can result in false-negative and false-positive test results. Therefore, before you begin the test, it is very important to read the package insert provided in the test package and follow the instructions.

The Flowflex Plus COVID-19 + Flu A/B Home Test was compared to highly sensitive PCR tests. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at flowflexcovid.com.

A pinkish background color on the test strip will not affect the result of your test.

Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 + Flu A/B Home Test kits that were frozen are still working. Make sure the entire kit is back to room temperature and that the extraction buffer is thawed and back to liquid solution form before the kit is used for the testing.

Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 + Flu A/B Home Test kits that were exposed to temperatures above average (up to 65 °C / 150 °F) for a few hours are still working. Make sure the entire kit is cooled back to room temperature and there is still a least 1/3 of an inch of buffer in the tube before the kit is used for the testing.

Troubleshooting

Flowflex® Plus COVID-19 + Flu A/B Home Test

Please fill out the Contact Us form (Contact Us – Flowflexcovid.com) and provide the Lot number and location where the product was purchased. Customer Service hours are 5 a.m. – 5 p.m. (PST), 7 days a week.

The solution should be clear and colorless. If you receive a solution that has a yellow color, do not use this test kit. Please contact customer service at (800) 838-9502 for assistance. Customer Service hours are 8 a.m. – 8 p.m. (EST), 7 days a week.

You should dispense 4 drops of solution into the cassette Sample Well. Please do not overuse the buffer solution.

You should dispense 4 drops of solution into the cassette Sample Well marked with an “S”.

Do not use the test and contact customer service at (800) 838-9502. Customer Service hours are 5 a.m. – 5 p.m. (PST), 7 days a week.

Please do not swab your throat/ear. Please only swab your nose to collect samples and follow procedures on the Quick Reference Instructions.

Please do not swab your throat/ear. Please only swab your nose to collect samples and follow procedures on the Quick Reference Instructions.

Yes, discoloration of the swab tip is normal and due to UV exposure. The swab is safe to use and will have no impact on test performance.

Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 + Flu A/B Home Test kits that were frozen are still working. Make sure the entire kit is back to room temperature and that the extraction buffer is thawed and back to liquid solution form before the kit is used for the testing.

Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 + Flu A/B Home Test kits that were exposed to temperatures above average (up to 65°C/ 150°F) for a few hours are still working. Make sure the entire kit is back to room temperature and there is still at least 1/3 of an inch of buffer in the tube before the kit is used for the testing.

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