Description
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
Storage Requirements: 59°F to 86°F
Processing Time: 15 Minutes
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.
Key Features and 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.
