Quidel Sofia™ 2 SARS Antigen Fluorescent Immunoassay (FIA)

Uses immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. Provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

Catalog Number	Mfr. No.	Sample Type
23-043-151	Quidel 20374	Direct or VTM: Nasal swab, nasopharyngeal swab
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23-043-153	Quidel 20383	Nasopharyngeal

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.

Specifications

• Description: Test Kit
• For Use With (Equipment): For use with Quidel Sofia 2 Analyzer, Cat. No. 20299.
• Quantity: 25 Tests/Pk. or 300 Tests/Cs.

• Clia Complexity: Waived
• Includes: Cassettes, Reagent tubes, Reagent solution, Swabs, Pipettes (sufficient for 25 tests); Control swabs 1-pos 1-neg
• Test Time: 15 min.