Sofia SARS Antigen FIA

1.800.874.1517

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.

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 or VTM: Nasal swab, nasopharyngeal swab
Kit storage conditions	Room temperature (15°C to 35°C / 59°F to 86°F)
Controls	Positive and negative, included in kit
PPA	87.5
NPA	100%
CLIA complexity	Moderate complexity*

*Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.