Clinical Performance Evaluation of KnowNow SARS-CoV-2 Test for the Detection of COVID-19 Antigen
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test
研究概览
简要总结
This is an international, multicentre, non-interventional, observational study to assess the clinical diagnostic performance of a rapid, point of care (POC) COVID-19 (SARS-CoV-2) antigen In vitro diagnostic (IVD), The KnowNow SARS-CoV-2 Rapid Antigen Test, using saliva samples when compared to reverse transcription polymerase chain reaction (RT-PCR) as the standard detection of COVID-19 infection.
详细描述
The KnowNow SARS-CoV-2 Rapid Antigen Test which uses saliva and is a lateral flow diagnostic device that can detect the SARS-CoV-2 specific Antigens that are present on the surface of the virus. The KnowNow test is an affordable, user friendly, and point of care device that can be mass produced as part of a multipronged strategy to address the global COVID-19 pandemic.
A saliva sample is collected from someone with suspected COVID-19 and mixed with a running buffer. The mixture is added to the sample pad of the KnowNow test, from where it migrates through the lateral flow strip. If COVID-19 Antigens are present, they bind to capture proteins on a test line and are made visible by secondary reagents within the device. The test result is visually assessed after 15-30 minutes and provides a binary positive (two lines) or negative (one line) result. Levels of COVID-19 Antigen differ dependent on disease progression. A visible test line (marked T) indicates the presence of COVID-19 Antigen in sufficient quantity in the collected sample to be detected. The appearance of the control line (marked C) confirms that the test has been performed correctly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Male or female aged 18 years or over (or age of adult consent in some states within the United States).
- •Suspected COVID-19 infection and / or presenting with at least 1 recognised symptom Fever or chills. ie: Cough. Shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat
- •Be willing and able to comply with study procedures.
- •Be able to give written informed consent.
排除标准
- •Inability to give written informed consent.
- •Vaccinated against SARS-CoV-2
- •Adults unable to undertake the requirements of the nasopharyngeal or saliva sample collection for physical or psychological reasons
- •Subjects with other significant disease, condition, or at the Clinician's discretion.
结局指标
主要结局
Assess clinical diagnostic performance of the KnowNow SARS-CoV-2 Rapid Antigen Test
时间窗: 6 months
This includes determination of the sensitivity/positive percent agreement (PPA), specificity/negative percent agreement (NPA), positive predicted value (PPV) and negative predictive value (NPV).
次要结局
- Efficacy to assess the test compared to the reference test method(6 months)
- Usability Questionnaire to evaluate the use of the test with 2 saliva collection methods(6 months)