May 2023—QuidelOrtho Corp. has been granted a de novo request from the FDA for its new Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer. It is intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from people with signs and symptoms of upper respiratory infection when serial testing is started within six days of symptom onset. The Sofia 2 analyzer provides a result in 10 minutes.
QuidelOrtho, 858-551-1100