GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Arion Bio

Status

Completed

Conditions

Covid 19

Treatments

Diagnostic Test: GlowTest COVID-19 Antigen Home Test

Study type

Interventional

Funder types

Industry

Identifiers

NCT05140005

AB-001-01

Details and patient eligibility

About

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.

Full description

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).

Enrollment

33 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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.