NCT04805892已完成不适用
Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care
Mach-E B.V.2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
研究概览
简要总结
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
- •Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
- •Currently experiencing symptoms of COVID-
- •Be clinically diagnosed or suspected to have COVID-
- •Recent past (3 weeks) exhibited symptoms of COVID-
- •Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
- •Interacted with a COVID-19 positive individual.
排除标准
- •Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
- •Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
- •Have a deviated nasal septum.
- •Cognitively impaired individuals resulting in the inability to provide informed consent
结局指标
主要结局
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
时间窗: 1 visit, up to 2 hours
The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula.
次要结局
- Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.(1 visit, up to 2 hours)
研究者
研究点 (2)
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