What is the risk of a false positive or false negative result?

There is a very small chance that this rapid antigen test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. Your healthcare provider will work with you to determine how best to care for you based on the rapid antigen test results along with medical history, and your symptoms. Please see the FDA Patient Fact Sheet for more information.

It is possible for this rapid antigen 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 rapid antigen test is negative. If your rapid antigen test result is negative, your healthcare provider will consider the rapid antigen 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. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay. Please see the FDA Patient Fact Sheet for more information.