An observational study in COVID-19, sponsored by Arion Bio. Completed at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by Arion Bio · Observational
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.
7,776 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 35 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Arion Bio is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
15 subjects 14 years of age and older
Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit
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
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.
Time frame: 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.
Time frame: 90 minutes
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Arion Bio