COVID-19NCT05172154
GlowTest COVID-19 Antigen Home Test Kit Usability Study
An observational study of COVID-19, run by Arion Bio at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- GlowTest COVID-19 Antigen Home Test Kit
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlowTest COVID-19 Antigen Home Test Kit Usability
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.
Read the 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.
- Conditions
- COVID-19
- Being tested
- GlowTest COVID-19 Antigen Home Test Kit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlowTest COVID-19 Antigen Home Test KitDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 15 subjects testing themselves | 15 subjects 14 years of age and older Receives: Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit | |
| 15 subjects testing someone else | 15 adult subjects testing individuals ages 2-13 Receives: Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start30 Dec 2021
- Primary completion12 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arion Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Responsible party
- Sponsor
- Investigators
- Steven Geller, MD, Principal investigator, Centennial Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172154
- Sponsor's protocol ID
- AB-001-02
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlowTest COVID-19 Antigen Home Test Kit Usability
- ClinicalTrials.gov ID
- NCT05172154
- Acronym / sponsor ID
- AB-001-02
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Arion BioIndustry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 subjects testing themselves | – | Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit15 subjects 14 years of age and older |
| 15 subjects testing someone else | – | Diagnostic Test: GlowTest COVID-19 Antigen Home Test Kit15 adult subjects testing individuals ages 2-13 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlowTest COVID-19 Antigen Home Test KitThe 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 | Diagnostic test | 15 subjects testing someone else, 15 subjects testing themselves |
Primary outcome
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Time frame: 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
Time frame: 90 minutes
Track usability of the test by asking subjects a series of questions regarding the ease of use of the test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Geller, MD principal investigator
Centennial Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Arion Bio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.