GlowTest COVID-19 Antigen Home Test Kit Usability Study
NCT ID: NCT05172154
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2021-12-30
2022-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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15 subjects testing themselves
15 subjects 14 years of age and older
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
ALL
Yes
Sponsors
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CSSi Life Sciences
INDUSTRY
Arion Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Geller, MD
Role: PRINCIPAL_INVESTIGATOR
Centennial Medical Group
Locations
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Centennial Medical
Elkridge, Maryland, United States
Countries
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Other Identifiers
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AB-001-02
Identifier Type: -
Identifier Source: org_study_id
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