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GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

Sponsor
Arion Bio (Industry)
Overall Status
Completed
CT.gov ID
NCT05140005
Collaborator
CSSi Life Sciences (Industry)
33
Enrollment
1
Location
2
Arms
11
Actual Duration (Days)
91.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GlowTest COVID-19 Antigen Home Test
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
GlowTest COVID-19 Antigen Home Test Kit Usability Study
Actual Study Start Date :
Dec 6, 2021
Actual Primary Completion Date :
Dec 14, 2021
Actual Study Completion Date :
Dec 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 15 subjects testing themselves

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

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

    		•
    Other: 15 subjects testing someone else

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. QRI Usability - Observer [90 minutes]

      Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.

    2. QRI Usability - Participant [90 minutes]

      Assess the usability of the kit for home use based upon participant evaluation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centennial Medical Elkridge Maryland United States 21075

    Sponsors and Collaborators

    • Arion Bio
    • CSSi Life Sciences

    Investigators

    • Principal Investigator: Steven Geller, MD, Centennial Medical Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arion Bio
    ClinicalTrials.gov Identifier:
    NCT05140005
    Other Study ID Numbers:
    • AB-001-01
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Arion Bio
    Virus
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Dec 20, 2021