COVID-19 test kit Sofia®

for antigensSARS-COV-2nasopharyngeal

The Sofia SARS Antigen fluorescent immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially. Healthcare professionals can purchase the Sofia SARS Antigen FIA through select authorized distributors. The Sofia® SARS Antigen FIA has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner. Features & benefits Dual work modes adjust to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode. All necessary components included in kit are ready for use with Sofia 2 and Sofia for nasal swab procedure. Specifications Product specifications Kit storage conditions - Room temperature (15°C to 35°C / 59°F to 86°F) Controls - Positive and negative, included in kit PPA - 96.7% NPA - 100% CLIA complexity - Waived*