Aptitude Medical’s Metrix COVID-19 Test Authorized
The FDA has granted Emergency Use Authorization (EUA) to Aptitude Medical Systems’ Metrix COVID-19 test.
The single-use molecular test, which uses nucleic acid amplification technology, is authorized for non-prescription home use for qualitative detection of nucleic acid from the SARS-CoV-2 virus.
The device uses nasal swab and saliva specimens, self-collected by individuals 14 years or older or collected by adults from any individual two years or older.
Results from the Metrix COVID-19 test do not rule out co-infection with other viruses or bacteria, the FDA said.