GlowTest COVID-19 Antigen Home Test Kit Usability Study

Completed

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

• Registration Number: NCT05172154
• Lead Sponsor: Arion Bio

Brief Summary

The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2021-12-24
• Study First Posted: 2021-12-29
• Study Start: 2021-12-30
• Status Verified: 2022-01
• Primary Completion: 2022-01-12
• Study Completion: 2022-01-14
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
2. Male and female Subjects 2 years of age and older.
3. 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.)
4. Subject agrees to complete all aspects of the study.

Exclusion Criteria

1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
2. Subject has prior medical or laboratory training.
3. Subject uses home diagnostics, e.g., glucose meters, HIV tests.
4. Subject has prior experience with home COVID test kits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
15 subjects testing someone else	GlowTest COVID-19 Antigen Home Test Kit	15 adult subjects testing individuals ages 2-13
15 subjects testing themselves	GlowTest COVID-19 Antigen Home Test Kit	15 subjects 14 years of age and older

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centennial Medical; 🇺🇸 Elkridge, Maryland, United States