Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™) (CoviDx™)
2022年11月11日 更新者:Lumos Diagnostics
Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
研究概览
详细说明
Subjects who are currently experiencing symptoms associated with COVID-19 will be enrolled.
Each enrolled subject will either self-collect one sample from the anterior nares or have the sample collected by another lay individual.
Each subject will then have a mid-turbinate nasal swab sample collected for comparator test
研究类型
观察性的
注册 (实际的)
45
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Tampa、Florida、美国、33613
- Pas Research
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Lay users who do not have medical or laboratory experience significant experience performing repeated self-testing.
Subjects will be 2 years of age or older and have symptoms of COVID-19 that started ≤ 5 days from their study visit
描述
Inclusion Criteria:
- Mid-turbinate nasal swab collected for SARS-CoV-2 RT-PCR at the same time of CoviDx Rapid Antigen swab collection
- Symptomatic subjects suspected of having COVID-19, first onset of COVID-19-like symptoms (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) should not have started more than 5 days from the time of the study visit. Symptoms must be present on the day of CoviDx testing.
- ≥ 2 years of age
- Participants between 2-13 years of age, inclusive, must participate with a guardian who will be collecting the swab.
- Signed Informed Consent
Exclusion Criteria:
- Participants with prior medical or laboratory training
- Unable or unwilling to provide signed, Informed Consent
- Less than 2 years of age
- Received a positive diagnostic test result for COVID-19 in the past 14 days
- Received a negative diagnostic test result for COVID-19 in the last 18 hours
- Study Comparator collection that occurred > 3 hours from CoviDx swab collection
- For symptomatic participants: first onset of COVID-19-like symptoms occurring more than 5 days from study visit
- Invalid or missing study comparator test results
- Use of a non-high-sensitive SARS-CoV-2 test as the comparator SARS-CoV-2 RT-PCR test (e.g., rapid molecular, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
- Enrollment in another study involving the collection of a nasopharyngeal, mid-turbinate nasal swab or anterior nasal swab within 6 hours of CoviDx testing.
- Indicates they would not use a COVID-19 diagnostic test kit in real life
- Taking any of the following medications or treatments within 7 days of study visit (antivirals (e.g., Remdesivir, Paxlovid) and/or monoclonal antibodies (e.g., REGEN-COV (casirivimab, imdevimab), Sotrovimab (Xevudy), Evusheld)
- Nasal spray administration in the last 48 hours
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test
Sequentially enrolled symptomatic patients will have a nasal swab collected for high-sensitive SARS-CoV-2 RT-PCR testing as comparator and self collect a nasal swab for CoviDx™ Covid-19 Antigen self-testing.
Order of tests will be performed following a randomization scheme.
|
All patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Performance of CoviDx Covid-19 Antigen Self-Test in nasal swab as compared to a high-sensitive SARSCoV- 2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA
大体时间:60 days
|
Evaluate the performance (positive percent agreement (PPA) and negative percent agreement (NPA)) of the CoviDx™ COVID-19 Antigen Self-Test for the detection of SARS-CoV-2 virus antigen in anterior nasal swab (NS) samples collected by lay users compared to results obtained from by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA (comparator test).
|
60 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月17日
初级完成 (实际的)
2022年8月1日
研究完成 (实际的)
2022年10月31日
研究注册日期
首次提交
2022年6月1日
首先提交符合 QC 标准的
2022年6月1日
首次发布 (实际的)
2022年6月3日
研究记录更新
最后更新发布 (实际的)
2022年11月16日
上次提交的符合 QC 标准的更新
2022年11月11日
最后验证
2022年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
新冠肺炎的临床试验
-
Texas Woman's UniversityNational Institutes of Health (NIH)尚未招聘COVID19测试
-
Aarhus University HospitalUniversity of Aarhus; Pharma Nord完全的
-
Diffusion Pharmaceuticals Inc完全的
-
Lumos DiagnosticsRapid Pathogen Screening完全的
-
Cairo UniversityKasr El Aini Hospital未知
-
Assistance Publique - Hôpitaux de Paris未知
CoviDx™ Covid-19 Antigen Self-Test的临床试验
-
Foundation for Innovative New Diagnostics, Switzerland主动,不招人
-
Groupe Hospitalier Paris Saint Joseph完全的
-
Abbott Rapid Dx完全的
-
Foundation for Innovative New Diagnostics, SwitzerlandBotswana Harvard AIDS Institute Partnership完全的
-
Thermo Fisher Scientific, IncNAMSA完全的