Quidel Sofia™ 2 SARS Antigen Fluorescent Immunoassay (FIA)

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.

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 nasal swab procedure
• Self-contained Test Cassette that is clean, easy to use and dispose of.

Kit Includes:
(25) Individually Packaged Test Cassettes
(25) Reagent Tubes
(25) Ampoules of Reagent Solution
(25) Sterile Nasal Swabs
(25) x 120 µL Fixed Volume Pipettes
Positive Control Swab
Negative Control Swab
Package Insert
Quick Reference Instructions
QC Card



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.