Sofia SARS Antigen FIA Test Kit(20374)

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

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