DRKS00033528尚未招募不适用
Clinical Performance Evaluation of Sansure Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) - REQA_23005_SNSR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 7 Years 至 one（—）
- 性别
- All
入选标准
- •1. Age: = 18: Able to sign the informed consent form (ICF) independently. 2. Age: =7 years and <18 years; Signing the consent form (ICF) by first degree relative upon consent of the minor patient.
- •3. Participants who agree to the utilization of their samples for processing, storage, analysis, documentation, optional shipment as required by the applied SARS-CoV-2 test and publication of study results in anonymized manner
- •4. Subject must be presenting with 1 or more of the signs and symptoms of a respiratory infection. Experiencing at least one symptom of COVID-19 for 3 days or fewer from study enrolment (as far as possible).
排除标准
- •1. Vaccinated against COVID-19 within the last 48 hours
- •2. Ear, nose and throat (ENT) surgery within the last six months and/or encephalocele
- •3. Haemophilia and/or using anticoagulant drugs
- •4. Lack of compliance or other reasons that precludes satisfactory participation in the study as judged by the Investigator
- •5. Inability to understand the nature of, extent of, and procedures required by the study as judged by the Investigator
- •6. Participants who are dependent of the sponsor/investigator in any way.
研究者
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