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

Medical Group Care

Status: Completed

Conditions: Influenza A; COVID-19; Influenza B

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05732610

MGC-1001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Individuals - ages 14 and older

Experimental group

Description:

This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.

Treatment:

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

Individuals - ages 2 to 13

Experimental group

Description:

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.

Treatment:

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