Sofia SARS Antigen FIA

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For use with Sofia 2 and Sofia - FDA Emergency Use Authorization

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 testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

Healthcare professionals can purchase the Sofia SARS Antigen FIA through select authorized distributors.

Where can I go for updates and more information?

CDC:
General Information - Coronavirus (COVID-19)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control

FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)

Features & Benefits

Feature	Benefit
Results in 15 minutes	Rapid results to support efficient dispositioning of patients.
Objective, accurate results	Reliable results without cross-reactivity to seasonal coronaviruses.
Dual work modes	Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.
Easy to use	Simple test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays.
Virena connection	Provides automated tracking, data capture, government reporting, and exclusive disease mapping.
Fluorescent technology with automated read	Objective result that eliminates the subjectivity of a visual read.
All necessary components included in kit	Ready for use with Sofia 2 and Sofia for nasal swab procedure.
Self-contained Test Cassette	Clean, easy to use and dispose of.

Product Specifications

Product Spec Name	Product Spec Data
Time to results	15 minutes
Sample type	Direct nasal/nasopharyngeal swabs
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%
Shelf life	24 months from date of manufacture
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.