The Advin COVID-19 Antigen Test @Home is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in self-collected anterior nasal swab samples from individuals aged 14 years or older or with adult-collected anterior nasal samples from individuals aged 2 years or older. This test is for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests. For use under Emergency Use Authorization only. For in vitro diagnostic use. The Advin COVID-19 Antigen Test @ Home is intended for non-prescription self-use and/or, as applicable, for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The Advin COVID-19 Antigen Test @ Home is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA-cleared or approved. The Advin COVID-19 Antigen Test @Home does not differentiate between SARS-CoV and SARS-CoV-2.
