Description
Fact Sheet Patients
Fact Sheet Providers
MSDS
Package Insert
Quick Reference Guide
Unit: 1 Box (25 Tests)
Regulatory Status:FDA EUA for use in CLIA waived settings
Contents: Individually Packaged Test Cassettes (25), Reagent Tubes (25), Reagent Solution (25), Sterile Nasal Swabs (Kits #20374 and 20378) or Nasopharyngeal Swabs (Kit #20383) (25), Small, Clear 120 µL Fixed Volume Pipettes (25), SARS Positive Control Swab (1), Negative Control Swab (1), Package Insert (1), Quick Reference Instructions (1), QC Card (located on kit box)
Determinations: SARS COvid-19 and FLU A/B
Storage Requirements: 59°F to 86°F
Processing Time: 15 Minutes
For use with Sofia 2 and Sofia – FDA Emergency Use Authorization
The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the Point of Care.
