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NCT05172154 Clinical Trial

GlowTest COVID-19 Antigen Home Test Kit Usability Study

COVID-19 Clinical Trial

Official title:
GlowTest COVID-19 Antigen Home Test Kit Usability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05172154
Other study ID # AB-001-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 30, 2021
Est. completion date January 14, 2022

Study information
Verified date January 2022
Source Arion Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date January 14, 2022
Est. primary completion date January 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Centennial Medical Elkridge Maryland

Sponsors (2)
Lead Sponsor Collaborator
Arion Bio CSSi Life Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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