GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Study Overview
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Brief Summary
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The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

Detailed Description
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The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The 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 collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website. 30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).

Official Title
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GlowTest COVID-19 Antigen Home Test Kit Usability Study

Conditions
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Covid 19

Intervention / Treatment
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* Diagnostic Test: GlowTest COVID-19 Antigen Home Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities. Males and females ages 2 and older. Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.) 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 experience with home COVID test kits.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 15 subjects testing themselves<br>15 subjects will use the Glow Test Kit to test themselves for Covid 19. | Diagnostic Test: GlowTest COVID-19 Antigen Home Test<br>* diagnostic testing for Covid 19<br>* Other names: GlowTest;|
| Other: 15 subjects testing someone else<br>15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19. | Diagnostic Test: GlowTest COVID-19 Antigen Home Test<br>* diagnostic testing for Covid 19<br>* Other names: GlowTest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRI Usability - Observer | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | 90 minutes | 
| QRI Usability - Participant | Assess the usability of the kit for home use based upon participant evaluation. | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virus