GlowTest COVID-19 Antigen Home Test Kit Usability Study
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 15 subjects testing themselves 15 subjects 14 years of age and older |
Diagnostic Test: GlowTest 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
|
| 15 subjects testing someone else 15 adult subjects testing individuals ages 2-13 |
Diagnostic Test: GlowTest 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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
-
Male and female Subjects 2 years of age 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.- AB-001-02