GlowTest COVID-19 Antigen Home Test Kit Usability Study

NCT05172154 | Completed

• 1 other identifier: AB-001-02
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

15 subjects testing themselves

15 subjects 14 years of age and older

Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit

15 subjects testing someone else

15 adult subjects testing individuals ages 2-13

Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit

Interventions

GlowTest COVID-19 Antigen Home Test Kit DIAGNOSTIC_TEST

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 subjects testing themselves

Eligibility Criteria

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

You may qualify if:

• An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
• Male and female Subjects 2 years of age 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

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; 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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 29, 2021
• Study Start: December 30, 2021
• Primary Completion: January 12, 2022
• Study Completion: January 14, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)