COVID-19 Antigen FIA Test

Intended Use

COVID-19 Antigen FIA Test is the fluorescence immunoassay for direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasopharyngeal secretions and Oropharyngeal secretions of humans. It is intended to aid in the rapid diagnosis of SARS-CoV-2 viral infections. COVID-19 Antigen FIA Test should be used with recommended Immunofluorescence Analyzers. This assay is intended for professional use, only for an initial screening test. Negative results do not preclude SARS-CoV-2 viral infections and should be confirmed via cell culture or molecular assay.

Materials

● Test Device: Each foil pouched device has test line of antibodies specific to SARS-CoV-2 viral antigens, and a control line of anti-species antibody.

● Assay Buffer: Detergent, tris, sodium chloride, blocking reagent and 0.1% sodium azide as preservative.

● Extraction Tube: Tubes for sample processing and sample delivery into devices.

● Nozzle: Tube tips to filter sample when delivered into devices.

● Swab: Swabs for sample collection.

● Tube Stand: Stand to support tubes in a stable upright position.

● Package insert

Benefits

● Quick results in 15 minutes

● Identify acute infection with high sensitivity

● Objective result that eliminates the subjectivity of a visual read

Storage and Stability

● Store the COVID-19 Antigen FIA Kit at 2~30℃when not in use.

● Do not freeze.

● Kit contents are stable until the expiration dates marked on their outer packaging and containers.

Test Procedure

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