Introduction:
- Rapid, point-of-care test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
- FIA stands for Fluorescent Immunoassay, meaning it uses fluorescence technology for detection
Purpose:
- Used with Quidel's Sofia or Sofia 2 instruments to provide automated and objective results in 15 minutes.
- Designed for use with direct anterior nasal swab specimens from individuals suspected of COVID-19
- Also for serial testing of asymptomatic individuals
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
Emergency Use Authorization (EUA):
- This test was authorized by the FDA under an Emergency Use Authorization
- Means it has not been FDA cleared or approved in the traditional sense
- Its use is authorized for the duration of the public health emergency justifying the EUA for COVID-19 diagnostics
Kit Contents:
- A kit contains:
- Individually packaged test cassette
- Reagent tubes
- Reagent solution
- Sterile nasal swabs
- Pipettes
- Positive and negative control swabs
- Instructions
