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Completed

NCT Number: NCT05172154

GlowTest COVID-19 Antigen Home Test Kit Usability Study

The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centennial Medical

Elkridge, Maryland, 21075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Arion Bio

Industry

Collaborators

  • CSSi Life Sciences

Registry information

Official study title

GlowTest COVID-19 Antigen Home Test Kit Usability

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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