Covid 19
Conditions
Keywords
Virus
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).
Interventions
DIAGNOSTIC_TESTGlowTest COVID-19 Antigen Home Test
diagnostic testing for Covid 19
Sponsors
CSSi Life Sciences
Arion Bio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRI Usability - Observer | 90 minutes | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. |
| QRI Usability - Participant | 90 minutes | Assess the usability of the kit for home use based upon participant evaluation. |
Countries
United States
Outcome results
None listed