NEW YORK – Korean diagnostic firm Osang Healthcare received Emergency Use Authorization from the US Food and Drug Administration last week for its combination COVID-19 and influenza antigen test.
The QuickFinder COVID-19/Flu Antigen Self Test qualitatively detects and differentiates between COVID-19, influenza A, and influenza B antigens and is authorized for non-prescription home use, according to the FDA's authorization document. The lateral flow immunoassay is intended for use with anterior nasal swab specimens and is only authorized for use in people with signs and symptoms of respiratory infection within four days of symptom onset when tested at least twice in three days with at least 48 hours between tests, the FDA noted.
The EUA was granted to Osang Healthcare's US branch in Pasadena, California, and follows last month's EUA for the company's OHC COVID-19/Flu Antigen Test Pro, designed for point-of-care use in labs and clinics.