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Completed

NCT Number: NCT05732610

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza A Influenza B Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

L&A Morales Healthcare

Miami, Florida, 33142, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

self-collected direct anterior nares swab samples

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

Diagnostic Test

adult lay user collected anterior nares swab sample

Primary outcomes

  1. 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.

  2. 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:

    • Very easy to understand
    • Fairly easy to understand
    • Easy
    • Fairly difficult to understand
    • Very Difficult

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medical Group Care, LLC

Industry

Collaborators

  • CSSi Life Sciences

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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