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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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COVID-19, Influenza A, Influenza B

Intervention / Treatment
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* Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test
* Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individuals - ages 14 and older<br>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<br>* self-collected direct anterior nares swab samples<br>|
| Experimental: Individuals - ages 2 to 13<br>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)<br>* adult lay user collected anterior nares swab sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of Quick Reference Instructions (QRI) | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | One Month | 
| Usability of Test Kit | Assess the usability of the kit for home use based upon subject evaluation. | One Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Flu A, Flu B, Influenza