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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732610
• Other study ID #: MGC-1001
• Status: Completed
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: March 2, 2023

Study information

• Verified date: April 2024
• Source: Medical Group Care, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Influenza A
• Influenza B
• Influenza, Human

Intervention

Diagnostic Test:
• MGC Health COVID-19 & Flu A+B Home Multi Test
self-collected direct anterior nares swab samples
• MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)
adult lay user collected anterior nares swab sample

Locations

Country	Name	City	State
United States	L&A Morales Healthcare	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Medical Group Care, LLC	CSSi Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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: Very easy to understand; Fairly easy to understand; Easy; Fairly difficult to understand; Very Difficult	one hour
Primary	Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation	Assess the usability of the QRI based upon observer evaluation.	1 hour
Primary	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