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

April 8, 2024 updated by: Medical Group Care, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33142
        • L&A Morales Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of Quick Reference Instructions (QRI) - Critical Steps
Time Frame: 1 hour
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly.
1 hour
Usability of Test Kit
Time Frame: one hour

Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task.

The subject or adult lay user used the following 5-digit score to answer the questions:

  1. Very easy to understand
  2. Fairly easy to understand
  3. Easy
  4. Fairly difficult to understand
  5. Very Difficult
one hour
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Time Frame: 1 hour
Assess the usability of the QRI based upon observer evaluation.
1 hour
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Time Frame: 1 hour
Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Group Care, LLC

Collaborators

CSSi Life Sciences

Investigators

  • Study Director: Janice Cattano, RN, MSN, CSSi LifeSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGC-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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