GlowTest COVID-19 Antigen Home Test Kit Usability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Assess the usability of the kit for home use based upon participant evaluation
研究概览
简要总结
The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Assess the usability of the kit for home use based upon participant evaluation
时间窗: 90 minutes
Track usability of the test by asking subjects a series of questions regarding the ease of use of the test.
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
时间窗: 90 minutes
Track the percentage of subjects who perform the test correctly and according to the QRI.
次要结局
未报告次要终点