Diagnostic Accuracy of 2 cm Versus 4 cm Insertion Depth for Nasal Swabs for SARS-CoV-2 Rapid Antigen Testing-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy (sensitivity and specificity) of SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) using nasal swabs collected at 2 cm versus 4 cm insertion depth, with RT-PCR as the reference standard
研究概览
简要总结
This study aims to compare the diagnostic accuracy of rapid antigen detection tests (RDTs) for SARS-CoV-2 using nasal swab insertion depths of 2 cm versus 4 cm.
The study is an investigator-initiated, randomized clinical trial conducted at a public COVID-19 test center in Copenhagen, Denmark.
Following enrollment, participants complete a questionnaire regarding symptoms and vaccination status.
Participants are randomized in a 1:1 ratio to one of two sampling sequences: either a 2 cm swab in the left nostril and a 4 cm swab in the right nostril, or vice versa. All participants undergo a healthcare worker-collected throat swab for RT-PCR analysis, which serves as the reference standard for SARS-CoV-2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Citizens, aged 16 years or older, showing up for a SARS-CoV-2 RT-PCR test at Testcenter Valby in Copenhagen, Denmark
排除标准
- •non-fluent in Danish
- •citizens with nasopharyngeal or oropharyngeal anomalies (e.g. neck breathers with tracheostomy)
研究组 & 干预措施
2 cm nasal swab in the right nostril, and 4 cm nasal swab in the left nostril
干预措施: 4 cm nasal swab - left nostril (Diagnostic Test)
2 cm nasal swab in the right nostril, and 4 cm nasal swab in the left nostril
干预措施: 2 cm nasal swab - right nostril (Diagnostic Test)
4 cm nasal swab in the right nostril, and 2 cm nasal swab in the left nostril
干预措施: 2 cm nasal swab in the left nostril (Diagnostic Test)
4 cm nasal swab in the right nostril, and 2 cm nasal swab in the left nostril
干预措施: 4 cm nasal swab - right nostril (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy (sensitivity and specificity) of SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) using nasal swabs collected at 2 cm versus 4 cm insertion depth, with RT-PCR as the reference standard
时间窗: Baseline (during the study visit at the time of sample collection). Ag-RDT results were available immediately, whereas RT-PCR results were reported the following days (1-3 days).
次要结局
- Test discomfort on a 10-point VAS-scale(Baseline (during the study visit at the time of sample collection).)
- Self-reported symptoms of disease(Baseline (during the study visit at the time of sample collection). Self-reported symptoms of disease were collected immediately prior to testing, during the study visit.)
研究者
Tobias Todsen
MD, PhD. Principal investigator.
Rigshospitalet, Denmark