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| Name | Class |
|---|---|
| CSSi Life Sciences | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 subjects testing themselves | Other | 15 subjects will use the Glow Test Kit to test themselves for Covid 19. |
|
| 15 subjects testing someone else | Other | 15 subjects will use the Glow Test Kit to test someone else (a child) for Covid 19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlowTest COVID-19 Antigen Home Test | Diagnostic Test | diagnostic testing for Covid 19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| QRI Usability - Observer | Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | 90 minutes |
| QRI Usability - Participant | Assess the usability of the kit for home use based upon participant evaluation. | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Geller, MD | Centennial Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centennial Medical | Elkridge | Maryland | 21075 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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30 subjects split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child).
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|
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |