Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- RT-PCR for upper airway viral diagnostics
研究概览
简要总结
This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •The inclusion criterion:
- •A. 18 years or more of age requiring a test for COVID-
排除标准
- •A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
- •B. Do not understand oral or written Danish
研究组 & 干预措施
Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)
1 NPS right - Nasal swab left - OPS
NPS = nasopharyngeal swab OPS = oropharyngeal swab
干预措施: (NPS right - Nasal swab left - OPS) (Diagnostic Test)
Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)
2 NPS left - Nasal swab right - OPS
干预措施: (NPS left - Nasal swab right - OPS) (Diagnostic Test)
Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)
3 Nasal swab right - NPS left - OPS
干预措施: (Nasal swab right - NPS left - OPS) (Diagnostic Test)
Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)
4 Nasal swab left - NPS right - OPS
干预措施: (Nasal swab left - NPS right - OPS) (Diagnostic Test)
Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)
5 NPS right - OPS - Nasal swab left
干预措施: (NPS right - OPS - Nasal swab left) (Diagnostic Test)
Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)
6 NPS left - OPS - Nasal swab right
干预措施: (NPS left - OPS - Nasal swab right) (Diagnostic Test)
Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)
7 Nasal swab right - OPS - NPS left
干预措施: (Nasal swab right - OPS - NPS left) (Diagnostic Test)
Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)
8 Nasal swab left - OPS - NPS right
干预措施: (Nasal swab left - OPS - NPS right) (Diagnostic Test)
Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)
9 OPS - NPS right - Nasal swab left
干预措施: (OPS - NPS right - Nasal swab left) (Diagnostic Test)
Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)
10 OPS - NPS left - Nasal swab right
干预措施: (OPS - NPS left - Nasal swab right) (Diagnostic Test)
Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)
11 OPS - Nasal swab left - NPS right
干预措施: (OPS - Nasal swab left - NPS right) (Diagnostic Test)
Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)
12 OPS - Nasal swab right - NPS left
干预措施: (OPS - Nasal swab right - NPS left) (Diagnostic Test)
结局指标
主要结局
RT-PCR for upper airway viral diagnostics
时间窗: 1 day
the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B
次要结局
- local immunological mediators from the upper airway tract(1 day)
研究者
Tobias Todsen
MD, Phd, Consultant, Ass. Prof
Rigshospitalet, Denmark
