The MGC Health COVID-19 \& Flu A+B Home Multi Test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user collected anterior nares swab samples from individuals aged 2 to 13 years.
The objective of the study is to determine the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test in a simulated home use environment.
This is an open label study to evaluate the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).
