Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result
研究概览
简要总结
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-It COVID-19 Home Test, AllBio Science Inc. and Artron Laboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 after diagnosis with COVID-19 or following vaccination to measure the onset and time course of detectable antibodies from finger-stick blood drops and rapid antibody lateral flow tests. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support and provide evidence of antibody time-course response to vaccination.
详细描述
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 500 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2 responsible for COVID -19 using antigen-based tests. A second swab will be placed in transport media and transferred to a laboratory for testing using a high sensitivity EUA real-time (RT) PCR assay as the comparator method and the Ct values used to determine positive or negative. The order of sample collection will be randomized.
Serial testing for home use of the Test-It (Turklab) COVID-19 Rapid Antigen test will be tested in symptomatic and asymptomatic subjects.
Positive tests will be tested for SARS-CoV-2 variant using Whole Genome Sequencing Method by Amplicon-Based NGS (Quest Diagnostics).
Two to 4 health care professional operators per site, with a range of education and training, at a point of care setting will perform a COVID-19 Rapid test assay utilizing the Instructions for Use and/or Quick Reference Instruction.
Sample Population: Males and females, age 2 and older, with or without symptoms consistent with SARS-CoV-2 infection (COVID-19).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have experienced symptoms of COVID-19 and have been tested using a CDC approved or FDA registered and listed nucleic acid based test within 1 year of Feb 1,
- •Individuals who have been clinically diagnosed or suspected to have had COVID-
- •Individuals who are at the time of enrollment in the study currently or in the recent past (3 weeks) exhibiting symptoms of COVID-
- •Individuals capable of performing a finger stick blood drop draw or saliva collection and placing it in a sample collection tube.
- •Individuals that have interacted with a COVID-19 positive individual and are still exhibiting symptoms will be tested by a CDC approved or FDA registered nucleic acid based device.
- •Individuals must be capable of navigating a mobile device to take an image of the test using the camera and enter information into fields on the device and wireless/cellular capability to upload one or more images to a website server.
排除标准
- •Individuals incapable of pricking their finger and placing a drop of blood into a sample well.
- •Individuals who cannot navigate a mobile device and see the screen to navigate and enter information in fields or align the camera with the test image.
- •Pregnant woman are not excluded if they meet the inclusion criteria and age requirements.
- •Individuals with a deviated septum
- •Cognitively impaired individuals resulting in the inability to provide informed consent,
结局指标
主要结局
Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result
时间窗: 1 year
Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test
Self-test interpretation of result vs expert clinical image interpretation of result
时间窗: 1 year
Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician
Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis
时间窗: 1 year
Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19
次要结局
- Ease of self-testing procedure(1 year)