Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
研究概览
简要总结
The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.
详细描述
This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test.
The device to be studied is the Sona Saliva C-19 Rapid Self Test.
Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care.
Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time.
The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18+ years
- •Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
- •Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
- •Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
- •Provide written informed consent..
- •Patients may have recently been exposed, in close contact, show no symptoms or may be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 6 days:
- •Fever as self-described or measured ≥ 38 °C (100.4°F)
- •Shortness of Breath
- •Congestion or Runny Nose
- •Difficulty Breathing
- •Muscle or Body Aches
- •New loss of sense of taste or smell
- •General malaise All patients in whom a test result (positive or negative) is obtained from both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test, will be included in the performance analysis.
排除标准
- •All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.
- •Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.
- •Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.
- •Also, the following:
- •Patients unable to provide a saliva sample for rapid testing
- •Patients unable to provide written consent.
- •Patients previously enrolled in the study
- •Patients undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection
结局指标
主要结局
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
时间窗: 35 days from last patient enrolment
Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
次要结局
未报告次要终点