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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2023-03-02

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.

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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).

Conditions

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COVID-19 Influenza A Influenza B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

self-collected direct anterior nares swab samples

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.

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

adult lay user collected anterior nares swab sample

Interventions

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

self-collected direct anterior nares swab samples

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes