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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Other
15 subjects testing themselves 		15 subjects will use the Glow Test Kit to test themselves for Covid 19.
  • Diagnostic Test: GlowTest COVID-19 Antigen Home Test
    diagnostic testing for Covid 19
    Other names:
    • GlowTest
Other
15 subjects testing someone else 		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
    diagnostic testing for Covid 19
    Other names:
    • GlowTest

Recruiting Locations

More Details

NCT ID
NCT05140005
Status
Completed
Sponsor
Arion Bio

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.