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

NCT05732610 | Completed Results FDA Device

• 1 other identifier: MGC-1001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Influenza A; Influenza B

Keywords

COVID-19; Flu A; Flu B; Influenza

Outcome Measures

Primary Outcomes (4)

• Usability of Quick Reference Instructions (QRI) - Critical Steps

  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

  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

  Assess the usability of the QRI based upon observer evaluation.

  1 hour

• Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results

  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

Study Arms (2)

Individuals - ages 14 and older

EXPERIMENTAL

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

Individuals - ages 2 to 13

EXPERIMENTAL

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)

Interventions

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

self-collected direct anterior nares swab samples

Individuals - ages 14 and older

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

Individuals - ages 2 to 13

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Group Care, LLC: lead
• CSSi Life Sciences: collaborator

Study Sites (1)

L&A Morales Healthcare

Miami, Florida, 33142, United States

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Results Point of Contact

• Title: Tomaz Lovse
• Organization: Medical Group Care

tomaz.lovse@mgc.us

239 631 1907

Study Officials

• Janice Cattano, RN, MSN

  CSSi LifeSciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 15, 2023
• First Posted: February 17, 2023
• Study Start: February 14, 2023
• Primary Completion: February 28, 2023
• Study Completion: March 2, 2023
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-04

Locations

US (1)