Results and Accuracy - Flu
Flowflex® Plus COVID-19 and Flu A/B Home Test
How to interpret the results?
Please refer to the Quick Reference Instructions on how to use this test.
What do the red lines on the cassette mean after I complete the 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.
What does it mean if I have a positive test result?
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).
What does it mean if I have a negative test result?
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.
What does it mean to have an invalid result?
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.
What is a false-positive and a false-negative test result?
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.
How accurate is this test?
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. 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.
Is the test result still valid if I see a pinkish color on the test strip after applying the sample to the test cassette sample well?
A pinkish background color on the test strip will not affect the result of your test.
The package containing my Flowflex Plus COVID-19 and Flu A/B Home Test was left outside in freezing temperatures for a few hours – below the storage temperature listed on the kit box. Will it affect the tests' performance, and should I throw the test away?
Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 and 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.
The package containing my Flowflex Plus COVID-19 and Flu A/B Home Test was left outside in very high temperatures for a few hours – above the storage temperature listed on the kit box. Will it affect the tests’ performance, and show I throw the tests away?
Our R&D Dept. has checked and confirmed that the Flowflex Plus COVID-19 and 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.
