MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study

Launched by MEDICAL GROUP CARE, LLC · Feb 15, 2023

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study related activities.
• • Male and female subjects 2 years of age and older.
• • Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay user will collect the sample.)
• • Subject agrees to complete all aspects of the study.
• Exclusion Criteria:
• • Subject has a visual impairment that cannot be restored with glasses or contact lenses.
• • Subject has prior medical or laboratory training.
• • Subject uses home diagnostics, e.g., glucose meters, HIV tests.
• • Subject has prior knowledge of their current COVID-19 or flu infection status.