Description
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.
Contents: 25 Test devices in sealed aluminum foil pouch with desiccant, 25 Empty reagent tubes, 25 Ampules containing extraction buffer (0.3mL), 25 Sample collection swabs, 1 Positive control swab, 1 Negative control swab, 1 Instructions for Use, 1 Quick Reference Instruction
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen, Influenza A&B
Storage Requirements: 36-86°F (2-30°C)
Processing Time: 15 Minutes
The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
COVID-19 and influenza are acute, highly contagious viral infections primarily affecting the respiratory tract. Immunologically diverse, singlestranded RNA viruses cause them: SARS-CoV-2 for COVID-19 and various influenza viruses (Types A, B, and C). Type A influenza is most prevalent and linked to severe illnesses, often causing epidemics. Type B
causes milder illness and less frequent outbreaks, while Type C rarely causes widespread disease.
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