SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
研究概览
简要总结
This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.
详细描述
Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reads and understands English or Spanish
- •Willing and able to provide consent
- •Diagnosed with COVID-19 or at high risk of disease based on objective criteria
排除标准
- •Unwilling or unable to provide consent.
- •Pregnant female
结局指标
主要结局
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
时间窗: up to 7 days
TaqPath RT-PCR assay performed on saliva compared to TaqPath RT-PCR performed on nasopharyngeal samples for assay accuracy, concordance, reproducibility/precision, analytical sensitivity and analytical specificity.
次要结局
未报告次要终点