Sofia2 Sars Antigen Fia

Drug Details

The Sofia 2 SARS Antigen+ FIA is a rapid diagnostic test designed to detect the presence of SARS-CoV-2, the virus responsible for COVID-19, in individuals exhibiting symptoms of upper respiratory infection. Utilizing advanced immunofluorescence-based lateral flow technology, this test identifies the nucleocapsid protein antigen from the virus in anterior nasal swab specimens. When used with the Sofia 2 analyzer, it delivers automated and objective results in just 10 minutes, facilitating prompt decision-making in clinical settings. The test is intended for use within six days of symptom onset and is authorized for point-of-care settings under a CLIA waiver, allowing broader accessibility in various healthcare environments. Notably, the Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023, marking it as the first rapid antigen test for COVID-19 to achieve this status.