MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Usability of Quick Reference Instructions (QRI) [One Month]
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
- Usability of Test Kit [One Month]
Assess the usability of the kit for home use based upon subject evaluation.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | L&A Morales Healthcare | Miami | Florida | United States | 33142 |
Sponsors and Collaborators
- Medical Group Care, LLC
- CSSi Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MGC-1001