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GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Primary Purpose

Covid 19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlowTest COVID-19 Antigen Home Test
Sponsored by
Arion Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid 19 focused on measuring Virus

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Centennial Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

15 subjects testing themselves

15 subjects testing someone else

Arm Description

15 subjects will use the Glow Test Kit to test themselves for Covid 19.

15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
December 17, 2021
Sponsor
Arion Bio
Collaborators
CSSi Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05140005
Brief Title
GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
Official Title
GlowTest COVID-19 Antigen Home Test Kit Usability Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arion Bio
Collaborators
CSSi Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19
Keywords
Virus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 subjects testing themselves
Arm Type
Other
Arm Description
15 subjects will use the Glow Test Kit to test themselves for Covid 19.
Arm Title
15 subjects testing someone else
Arm Type
Other
Arm Description
15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19.
Intervention Type
Diagnostic Test
Intervention Name(s)
GlowTest COVID-19 Antigen Home Test
Other Intervention Name(s)
GlowTest
Intervention Description
diagnostic testing for Covid 19
Primary Outcome Measure Information:
Title
QRI Usability - Observer
Description
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Time Frame
90 minutes
Title
QRI Usability - Participant
Description
Assess the usability of the kit for home use based upon participant evaluation.
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Geller, MD
Organizational Affiliation
Centennial Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centennial Medical
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

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