Feasibility Testing of a New COVID-19 Testing Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Device Accuracy - False positive and False negative percentage
研究概览
简要总结
The purpose of this study is to determine the reliability of a low-cost rapid diagnostic test for COVID-19. The method of the testing procedure uses electrochemistry to detect COVID-19 spike proteins within human samples. To test the effectiveness of this new method, patients will be recruited as they present for testing at ambulatory Penn testing sites. Patients will be asked to self-collect one anterior nares samples under the supervision of authorized study personnel.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be an adult (age>17) and either sex.
- •Written informed consent must be obtained prior to study enrollment.
- •a. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.
- •Subject must be able to read and write in English.
排除标准
- •The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- •The subject has previously participated in this research study.
结局指标
主要结局
Device Accuracy - False positive and False negative percentage
时间窗: 3 Months
The accuracy of the test will also be determined based on the percentage of false-positives and false-negatives compared to the gold standard clinical PCR test.
Device Accuracy - Positive and Negative Percentage
时间窗: 3 Months
The accuracy of the new prototype testing method will be determined by comparing the prototype's result to the clinical gold standard PCR test. The accuracy will be determined by calculating the percentage of the test's ability to correctly identify both the presence and absence of virus compared to the PCR result for the positive and negative results.
次要结局
未报告次要终点