Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs
研究概览
地位
详细说明
Primary Objective: To evaluate the Clinical Performance of iStatis COVID-19 Antigen Test by untrained operators at Point of Care settings that meet requirements for CLIA waived tests.
Secondary Objective: To evaluate the performance of iStatis COVID-19 Antigen test around Limit of Detection Samples will be collected in CLIA Waived settings from approximately 200 subjects who present with or are referred for concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders, and races.
Individual participation only includes sample collection and 1 day visit for the purpose of study
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Fort Lauderdale、Florida、美国、33308
- Therafirst Medical Center
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Maryland
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Elkridge、Maryland、美国、21075
- Centennial Medical Group
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant is willing to sign verbal informed consent form
- Age 18 or older
- Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
- Subjects with above mentioned symptom onset within the 7 days
- Participant is willing to provide two swabs - one anterior nasal swab sample for iStatis Test and another nasopharyngeal or nasal swab sample for comparator RT-PCR testing
Exclusion Criteria:
- Individuals who presented with 8 or greater days of COVID- 19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or postdefervescence and/or convalescence
- Any reason as identified by the Principal Investigator at the participating site that could disqualify the subject from participation. The reason for exclusion was documented
- Subject withdraw consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device
An anterior nasal swab was collected using the swab provided with the iStatis test kit and will be used for the iStatis Covid-19 Antigen Testing at the site.
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SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
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有源比较器:Anterior nasal swab sample tested with RT-PCR
Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory.
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The Labcorp COVID-19 RT-PCR or EURORealTime SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
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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 |
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Summary of the iStatis COVID-19 Ag test performance data compared to the comparator EUA RT-PCR test when all data from 4 POC/CLIA sites are combined.
大体时间:2 - 3 weeks
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The primary efficacy analyses will be analysis of relative positive percent agreement (PPA) and negative percent agreement (NPA) of the iStatis COVID-19 Antigen test results compared with the participant's RT-PCR results. The overall lower 95% confidence interval will be determined when: Positive Percent Agreement (PPA) = [TP / (TP + FN)] x 100, where
Negative Percent Agreement (NPA) = [TN / (TN + FP)] x100, where
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2 - 3 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
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