Saturday, October 1, 2022

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication | FDA

Most at-home COVID-19 tests are antigen tests and do not detect the SARS-CoV-2 virus as well as molecular tests, most of which are laboratory-based such as polymerase chain reaction (PCR) tests. Molecular COVID-19 tests are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected. However, at-home COVID-19 antigen tests are generally expected to detect the SARS-CoV-2 virus at least 80% of the time when someone is infected.

When you perform an at-home COVID-19 antigen test, and you get a positive result, the results are typically accurate. However, if you perform an at-home COVID-19 antigen test, you could get a false negative result. 


The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.

https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication

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