COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
研究概览
简要总结
The main objective of the tests is to establish saliva collection with Salivette® Cortisol.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed and dated before any samples have been taken.
- •Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
- •Male and/or female patients aged 18 years and over.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
时间窗: At baseline (the test day), up to one day.
Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany
时间窗: At baseline (the test day), up to one day.
Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".
次要结局
未报告次要终点