GlowTest COVID-19 Antigen Home Test Kit Usability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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GlowTest COVID-19 Antigen Home Test Kit Usability

Conditions
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COVID-19

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


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. Male and female Subjects 2 years of age 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 15 subjects testing themselves<br>15 subjects 14 years of age and older | Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit<br>* 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<br>|
| 15 subjects testing someone else<br>15 adult subjects testing individuals ages 2-13 | Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | Track the percentage of subjects who perform the test correctly and according to the QRI. | 90 minutes | 
| Assess the usability of the kit for home use based upon participant evaluation | Track usability of the test by asking subjects a series of questions regarding the ease of use of the test. | 90 minutes |