MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
研究概览
简要总结
The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use.
详细描述
The MGC Health COVID-19 & Flu A+B Home Multi Test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. This 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 lay user collected anterior nares swab samples from individuals aged 2 to 13 years.
The objective of the study is to determine the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in a simulated home use environment.
This is an open label study to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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, if applicable, 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 the subject is under the age of 14, an adult lay user will collect the sample.)
- •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 knowledge of their current COVID-19 or flu infection status.
结局指标
主要结局
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
时间窗: 1 hour
Assess the usability of the QRI based upon observer evaluation.
Usability of Quick Reference Instructions (QRI) - Critical Steps
时间窗: 1 hour
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly.
Usability of Test Kit
时间窗: one hour
Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task. The subject or adult lay user used the following 5-digit score to answer the questions: 1. Very easy to understand 2. Fairly easy to understand 3. Easy 4. Fairly difficult to understand 5. Very Difficult
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
时间窗: 1 hour
Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests.
次要结局
未报告次要终点