GlowTest COVID-19 Antigen Home Test Kit Usability Study

Arion Bio

Status

Completed

Conditions

COVID-19

Treatments

Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit

Study type

Observational

Funder types

Industry

Identifiers

NCT05172154

AB-001-02

Details and patient eligibility

About

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

Full 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.

Enrollment

35 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.
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.

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