COVID-19
Conditions
Brief summary
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGlowTest COVID-19 Antigen Home Test Kit
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
Sponsors
CSSi Life Sciences
Arion Bio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities. 2. Male and female Subjects 2 years of age and older. 3. 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.) 4. Subject agrees to complete all aspects of the study.
Exclusion criteria
1. Subject has a visual impairment that cannot be restored with glasses or contact lenses. 2. Subject has prior medical or laboratory training. 3. Subject uses home diagnostics, e.g., glucose meters, HIV tests. 4. Subject has prior experience with home COVID test kits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | 90 minutes | Track the percentage of subjects who perform the test correctly and according to the QRI. |
| Assess the usability of the kit for home use based upon participant evaluation | 90 minutes | Track usability of the test by asking subjects a series of questions regarding the ease of use of the test. |
Countries
United States
Outcome results
None listed