GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

NCT05140005 | Completed FDA Device

• 1 other identifier: AB-001-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid 19

Keywords

Virus

Outcome Measures

Primary Outcomes (2)

• QRI Usability - Observer

  Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.

  90 minutes

• QRI Usability - Participant

  Assess the usability of the kit for home use based upon participant evaluation.

  90 minutes

Study Arms (2)

15 subjects testing themselves

OTHER

15 subjects will use the Glow Test Kit to test themselves for Covid 19.

Diagnostic Test: GlowTest COVID-19 Antigen Home Test

15 subjects testing someone else

OTHER

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

Interventions

GlowTest COVID-19 Antigen Home Test DIAGNOSTIC_TEST

diagnostic testing for Covid 19

Also known as: GlowTest

15 subjects testing someone else; 15 subjects testing themselves

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arion Bio: lead
• CSSi Life Sciences: collaborator

Study Sites (1)

Centennial Medical

Elkridge, Maryland, 21075, United States

Location

MeSH Terms

Conditions

COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven Geller, MD

  Centennial Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 1, 2021
• Study Start: December 6, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 17, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)