Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
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 (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; 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.
- •Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection 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.
- •Cannot perform self-collection of an oral fluid sample with use of oral fluid collection 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 (Saliva)
时间窗: 6 months
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
时间窗: 6 months
The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula.
次要结局
未报告次要终点