Results and Accuracy

Flowflex COVID-19 Antigen Home Test

How to interpret the results?

Please refer to your package insert on how to use this test.

What do the two red lines on the cassette mean after I complete the test?
If both the control line (C) and test line (T) appear, even if the line on the test line (T) is very faint, this means that you have a positive test result, because antigens from COVID-19 were detected, and it is very likely you currently have COVID-19. Please refer to the package insert for more information.
What does it mean if I have a positive test result?

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result. Your healthcare provider will work with you to determine how best to care for you based on your test result, medical history, and symptoms.

What does it mean if I have a negative test result?

A negative test result indicates that antigens from the virus that causes COVID-19 were not found in your sample. If you have symptoms, you likely do not have COVID-19. However, negative results do not rule out SARS-CoV-2 infection. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. For example, you may get a false negative result if you did not perform the test correctly or if the level of antigen from the virus causing COVID-19 was below the test limits. The amount of antigen in a sample may decrease the longer you have symptoms of infection. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.

What does it mean to have an invalid result?

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and the test should be run again, using a new test cassette and extraction buffer tube. If the problem persists, call (800) 838-9502 for assistance. Customer Service hours are 5a.m. – 5 p.m. (PST), 7 days a week.

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?

The performance of the Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. All subjects were screened for the presence or absence of COVID-19 symptoms within two weeks of study enrollment. The Flowflex COVID-19 Antigen Home Test was compared to an FDA authorized molecular SARS-CoV-2 test. The Flowflex COVID-19 Antigen Home Test correctly identified 93% of positive specimens and 100% of negative specimens.

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 tests was left outside in freezing temperatures for a few hours – below the storage temps. Will it affect the tests performance, and should I throw the tests away ?

Our R&D Dept. has checked and confirmed that the FlowFlex 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 tests was left outside in very high temperatures for a few hours – above the storage temps. Will it affect the tests performance, and should I throw the tests away ?

Our R&D Dept. has checked and confirmed that the FlowFlex 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.

I still can’t find the answer to my question, what do I do?