Fluorescent Immunoassay Analyzer Sofia® 2 CLIA Waived

Features

• Starter Kit, Sofia2 SARS+ Ag Starter Kit (Includes1 leased Sofia2 Instrument, Sofia SARS+ kit, Install Pack)
• Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023
• Sofia 2 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 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when serial testing is started within 6 days of symptom onset
• Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19
• Rapid results to support efficient dispositioning of patients
• Reliable results without cross-reactivity to seasonal coronaviruses
• Virena connection: Provides automated tracking, data capture, government reporting, and exclusive disease mapping
• Ready for use with Sofia 2 for nasal swab procedure
• The test does not differentiate between SARS-CoV and SARS-CoV-2
• A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay
• Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions
• Positive results do not rule out co-infection with other respiratory pathogens
• This test is intended for prescription use only and can be used in Point-of-Care settings
• Sofia SARS Antigen+ Kit includes: (25) Individually Packaged Cassettes, (25) Pre-filled Reagent Tubes (Buffer with Detergents, Reducing Agents and Proclin 300), (25) Dropper Tips, (25) Sterile Nasal Swabs, SARS Positive Control Swab, SARS Negative Control Swab, QC Card

More Information

• Sofia 2 SARS Antigen+ FIA Now CLIA Waived