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NCT05140005 | Completed | Covid 19

GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
Sponsor:

Arion Bio

Brief Summary:

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 or disease

Covid 19

Intervention/treatment

GlowTest COVID-19 Antigen Home Test

Phase

Not Applicable

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).}}

Study Type : Interventional
Estimated Enrollment : 33 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : GlowTest COVID-19 Antigen Home Test Kit Usability Study
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : December 14, 2021
Estimated Study Completion Date : December 17, 2021
Arm Intervention/treatment

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

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
Ages Eligible for Study: 2 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Location Details

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GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Maryland

Centennial Medical

Elkridge, Maryland, United States, 21075