Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 3
- 主要终点
- Positive Percent Agreement - Sensitivity
研究概览
简要总结
The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
详细描述
The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen 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 ages 2 to 13.
The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 94 Years（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 and 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 under the age of 14, the sample will be collected by an adult.)
- •Subject is willing to have a nasal swab collected by a healthcare professional.
- •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 had a positive COVID-19 test in past three (3) months.
- •Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.
研究组 & 干预措施
At least 30 children between 2 - 13 years of age
Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: Bio-Self COVID-19 Antigen Home Test (Device)
At least 30 children between 2 - 13 years of age
Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: Standard of Care COVID-19 Test (Device)
At least 30 children between 2 - 13 years of age
Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: RT-PCR Test (Diagnostic Test)
Subjects 14 - 90 years of age
The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: Bio-Self COVID-19 Antigen Home Test (Device)
Subjects 14 - 90 years of age
The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: Standard of Care COVID-19 Test (Device)
Subjects 14 - 90 years of age
The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
干预措施: RT-PCR Test (Diagnostic Test)
结局指标
主要结局
Positive Percent Agreement - Sensitivity
时间窗: 48 hours
The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.
Negative Percent Agreement - Specificity
时间窗: 48 hours
The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.
次要结局
未报告次要终点