GlowTest COVID-19 Antigen Home Test Kit Usability Study

GlowTest COVID-19 Antigen Home Test Kit Usability

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: GlowTest COVID-19 Antigen Home Test Kit

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
15 subjects testing themselves; 15 subjects 14 years of age and older	Diagnostic test: GlowTest COVID-19 Antigen Home Test Kit; 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
15 subjects testing someone else; 15 adult subjects testing individuals ages 2-13	Diagnostic test: GlowTest COVID-19 Antigen Home Test Kit; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arion Bio
• Collaborators: CSSi Life Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2021
• Primary Completion (ACTUAL): January 12, 2022
• Study Completion (ACTUAL): January 14, 2022

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (ACTUAL): December 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AB-001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No