POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- Establish Performance of Therma COVID-19 Rapid Antigen Test
研究概览
简要总结
The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.
The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.
The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing to sign verbal informed consent form
- •Age 12 or older and parents or legal guardians must consent for children as required by law.
- •Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
- •Participant is willing to provide a self-collected saliva sample
排除标准
- •Participant has previously tested positive for COVID-19 within the past 90 days
结局指标
主要结局
Establish Performance of Therma COVID-19 Rapid Antigen Test
时间窗: 1 day
To establish the performance characteristics of the Therma COVID-19 Rapid Antigen Test in a near-patient, point-of-care (POC) setting with lay users (no laboratory experience) testing a participant that has self-collected the saliva specimen. Clinical accuracy of the rapid antigen test compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the tests. The expected performance of the test for symptomatic participants shall be \>90% PPA and \>98% NPA.
次要结局
- Participant Feedback(1 day)
- User Feedback(1 day)