Novel Salivary Rapid Testing of SARS_CoV_2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Positive Agreement and Negative Percent Agreement
研究概览
简要总结
The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method
详细描述
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.
Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.
Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.
A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.
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
- •Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Presenting to the Emergency Department at HRH.
- •Receiving a COVID-19 RT-PCR test as per standard pathway of care.
- •Provide written informed consent.
- •Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 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
- •Sore Throat
排除标准
- •Asymptomatic patients.
- •Patients unable to provide a saliva sample.
- •Patients unable to give consent.
- •Patients who will not be receiving a nasopharyngeal RT-PCR test.
研究组 & 干预措施
SARS_CoV_2 Antigen Rapid Test
The same group of patients participated in two arms of the study:
One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.
干预措施: Sona Saliva C-19 Rapid Test (Diagnostic Test)
结局指标
主要结局
Percent Positive Agreement and Negative Percent Agreement
时间窗: 35 days from last patient enrolment
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.
次要结局
未报告次要终点