Quidel Sofia™ 2 SARS Antigen Fluorescent Immunoassay (FIA)

Description

• Rapid results in 15 minutes to support efficient dispositioning of patients Objective, accurate results without cross-reactivity to seasonal coronaviruses Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping
• Fluorescent technology with automated read eliminates the subjectivity of a visual result All necessary components included in kit, ready for use for swab procedure Self-contained Test Cassette that is clean, easy to use and dispose of Note: this test kit requires an analyzer
• (See Quidel Sofia 2 Analyzer, Cat
• No
• 20299) Note: CLIA Complexity is 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.