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| Name | Class |
|---|---|
| CSSi Life Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 subjects testing themselves | 15 subjects 14 years of age and older |
| |
| 15 subjects testing someone else | 15 adult subjects testing individuals ages 2-13 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlowTest COVID-19 Antigen Home Test Kit | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. | Track the percentage of subjects who perform the test correctly and according to the QRI. | 90 minutes |
| Assess the usability of the kit for home use based upon participant evaluation | Track usability of the test by asking subjects a series of questions regarding the ease of use of the test. | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).
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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 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |