Clinical trial NCT05140005: GlowTest COVID-19 Antigen Home Test Kit QRI Use Study
Official title: GlowTest COVID-19 Antigen Home Test Kit Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid 19
Keywords: Virus
Lead sponsor: Arion Bio
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2021-12-01
Enrollment: 33
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: QRI Usability - Observer
timeFrame: 90 minutes
measure: QRI Usability - Participant
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Elkridge
country: United States
facility: Centennial Medical
state: Maryland
Study officials:
affiliation: Centennial Medical Group
name: Steven Geller, MD
role: PRINCIPAL_INVESTIGATOR
References: