GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Not Applicable

Completed

• Conditions: Covid 19
• Interventions: Diagnostic Test: GlowTest COVID-19 Antigen Home Test

• Registration Number: NCT05140005
• Lead 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.

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 Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Status Verified: 2021-12
• Study First Posted: 2021-12-01
• Study Start: 2021-12-06
• Primary Completion: 2021-12-14
• Study Completion: 2021-12-17
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 subjects testing themselves	GlowTest COVID-19 Antigen Home Test	15 subjects will use the Glow Test Kit to test themselves for Covid 19.
15 subjects testing someone else	GlowTest COVID-19 Antigen Home Test	15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19.

Primary Outcome Measures

Name	Time	Method
QRI Usability - Observer	90 minutes	Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
QRI Usability - Participant	90 minutes	Assess the usability of the kit for home use based upon participant evaluation.

Trial Locations

Locations (1)

Centennial Medical; 🇺🇸 Elkridge, Maryland, United States