GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Covid 19 Clinical Trial

Official title:

GlowTest COVID-19 Antigen Home Test Kit Usability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140005
• Other study ID #: AB-001-01
• Status: Completed
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: December 17, 2021

Study information

• Verified date: December 2021
• Source: Arion Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 17, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid 19
• COVID-19

Intervention

Diagnostic Test:
• GlowTest COVID-19 Antigen Home Test
diagnostic testing for Covid 19

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	QRI Usability - Observer	Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.	90 minutes
Primary	QRI Usability - Participant	Assess the usability of the kit for home use based upon participant evaluation.	90 minutes