Print

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

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.