Post by icemandios on Jul 21, 2023 15:31:03 GMT
FDA Grants Emergency Use Authorization for Immunostics Home-Use COVID-19 Antigen Test
Jul 21, 2023 | staff reporter
antigen in adults and children using nasal swab samples.
NEW YORK – The US Food and Drug Administration this week granted Emergency Use Authorization for a home-use COVID-19 antigen test from Immunostics.
The Swab-N-Go Home Test COVID-19 Ag test is a nonprescription lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen using self-collected anterior nasal swab samples from adults and children ages 14 years and older and adult-collected samples from children younger than 14 years, according to the FDA.
It is authorized for use by symptomatic individuals within the first seven days of symptom onset when testing occurs at least twice over three days with at least 48 hours between tests as well as with asymptomatic individuals when testing occurs at least three times over five days with at least 48 hours between tests.
FDA officials said in February the agency was nearing the end of EUA reviews for COVID-19 and Mpox tests. The agency published in March guidance on how developers of medical devices for COVID-19 can transition from EUA status to full marketing and regulatory authorization.
Jul 21, 2023 | staff reporter
antigen in adults and children using nasal swab samples.
NEW YORK – The US Food and Drug Administration this week granted Emergency Use Authorization for a home-use COVID-19 antigen test from Immunostics.
The Swab-N-Go Home Test COVID-19 Ag test is a nonprescription lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen using self-collected anterior nasal swab samples from adults and children ages 14 years and older and adult-collected samples from children younger than 14 years, according to the FDA.
It is authorized for use by symptomatic individuals within the first seven days of symptom onset when testing occurs at least twice over three days with at least 48 hours between tests as well as with asymptomatic individuals when testing occurs at least three times over five days with at least 48 hours between tests.
FDA officials said in February the agency was nearing the end of EUA reviews for COVID-19 and Mpox tests. The agency published in March guidance on how developers of medical devices for COVID-19 can transition from EUA status to full marketing and regulatory authorization.