COVID-19 test kit Sofia® 2

fluSARS-COV-2influenza A

The Sofia 2 Flu + SARS Antigen fluorescent immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the point of care. Healthcare professionals can purchase the Sofia® 2 Flu + SARS Antigen FIA through select authorized distributors. Features & benefits One sample, three results mean time savings, material conservation, and patient comfort. Objective, accurate, reliable results without cross-reactivity to seasonal coronaviruses. Specifications Product specifications Kit storage conditions - Room temperature (15 °C to 35 °C / 59 °F to 86 °F) CLIA complexity - Waived* *fda.gov: The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.