GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Arion Bio33 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Covid 19

Interventions

GlowTest COVID-19 Antigen Home TestDIAGNOSTIC_TEST

diagnostic testing for Covid 19

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centennial Medical

Elkridge, Maryland, United States

Outcomes

Primary Outcomes

QRI Usability - Observer

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

Time frame: 90 minutes

QRI Usability - Participant

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

Time frame: 90 minutes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.