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

Purpose

The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use.

Conditions

  • COVID-19
  • Influenza A
  • Influenza B

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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).
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Individuals - ages 14 and older 		This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
  • Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test
    self-collected direct anterior nares swab samples
Experimental
Individuals - ages 2 to 13 		This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample.
  • Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)
    adult lay user collected anterior nares swab sample

Recruiting Locations

More Details

NCT ID
NCT05732610
Status
Completed
Sponsor
Medical Group Care, LLC

Detailed Description

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).