NCT04568122已完成不适用
Rapid Turnaround, Home-based Saliva Testing for COVID-19
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,277
- 试验地点
- 4
- 主要终点
- Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
研究概览
简要总结
The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection.
Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalized patients
- •Hospitalized at Stanford Health Care for COVID-related complications and tested positive for SARS-CoV-2 with a PCR-based test
- •Able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation
- •High-risk/positive population
- •Seeking testing for suspected COVID or a participant in a study of COVID-positive outpatients
- •Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.
- •Willing to participate in the study for 6 months
- •Low-risk population
- •Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.
- •Willing to participate in the study for 6 months
排除标准
- •All participants:
- •Participants with salivary gland dysfunction (including patients with Sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis)
- •Participants will not be eligible if they identify any reason they are unable to participate in the study
- •High-risk/positive population
- •Participants who have color blindness
- •Participants unable to operate the SnapDx device
- •Low-risk population
- •Participants with prior confirmed SARS-CoV-2 infection
- •Participants who have color blindness
- •Participants unable to operate the SnapDx device
结局指标
主要结局
Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability
时间窗: Up to 5 days per participant
Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.
Number of Positive Home Saliva Tests as Determined by the Patient
时间窗: Up to 5 days per participant
Validity Outcome.
次要结局
- Participant-rated Ease of Use(Up to 5 days per participant)
- Number of Participants That Called Technical Support(Up to 5 days per participant)
- Participant-rated Confidence in Interpreting Results(Up to 5 days per participant)
- Sample Integrity(Up to 5 days per participant)
- Sensitivity of Sample Test Kit(Up to 5 days per participant)
- Specificity of Sample Test Kit(Up to 5 days per participant)
研究者
研究点 (4)
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