Introduction:
- Rapid, fluorescent immunoassay (FIA) designed for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
- The "plus" in "Antigen+" indicates it's a newer generation of their antigen test for the Sofia 2 platform
Purpose:
- Primarily intended for use as an aid in the diagnosis of SARS-CoV-2 infections in symptomatic individuals when tested as part of a serial testing strategy
- Serial testing strategy is at least twice over three days with 48 hours between tests or when a single negative result is followed up with a molecular test
- It detects viral antigens generally present during the acute phase of infection
Rapid Results:
- Delivers results in approximately 10 minutes, which is crucial for quick patient dispositioning in healthcare settings
- Results are supplied by Sofia 2 Fluorescent Immunoassay Analyzer (PST-QUI-20299)
CLIA Waived:
- This classification means the test is simple to perform and has a low risk of erroneous results
- Makes it suitable for use in various healthcare settings, including those operating under a CLIA Certificate of Waiver
FDA Clearance/Authorization:
- First FDA-cleared 10-minute rapid antigen test for COVID-19
- Means it has gone through a more rigorous review process than tests under Emergency Use Authorization (EUA) alone
Kit Contents:
- A kit contains:
- Individually packaged test cassette
- Reagent tubes
- Dropper Tips
- Sterile Nasal Swabs
- SARS Positive Control Swab
- Negative Control Swab
- Package Insert
- Quick Reference Instructions
- QC Card
