Diagnostic Accuracy of 2 cm Versus 4 cm Insertion Depth for Nasal Swabs for SARS-CoV-2 (COVID-19) Rapid Antigen Testing-A Randomized Controlled Trial
Diagnostic Accuracy of 2 cm Versus 4 cm Insertion Depth for Nasal Swabs for SARS-CoV-2 Rapid Antigen Testing-A Randomized Controlled Trial
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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Copenhagen、丹麦
- Rigshospitalet
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Citizens, aged 16 years or older, showing up for a SARS-CoV-2 RT-PCR test at Testcenter Valby in Copenhagen, Denmark
Exclusion Criteria:
- non-fluent in Danish
- citizens with nasopharyngeal or oropharyngeal anomalies (e.g. neck breathers with tracheostomy)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：2 cm nasal swab in the right nostril, and 4 cm nasal swab in the left nostril
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a 4 cm nasal swab insertion in the left nostril
a 2 cm nasal swab insertion in the right nostril
|
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实验性的：4 cm nasal swab in the right nostril, and 2 cm nasal swab in the left nostril
|
a 2 cm nasal swab insertion in the left nostril
a 4 cm nasal swab insertion in the right nostril
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
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
大体时间：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).
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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).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Test discomfort on a 10-point VAS-scale
大体时间：Baseline (during the study visit at the time of sample collection).
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Test discomfort was evaluated using a 10-point visual analogue scale (VAS), ranging from 0 (no discomfort) to 10 (worst imaginable discomfort).
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Baseline (during the study visit at the time of sample collection).
|
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Self-reported symptoms of disease
大体时间：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.
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Self-reported symptoms of SARS-CoV-2 infection collected via questionnaire at enrollment, including presence, type, and duration of symptoms (e.g., fever, cough, sore throat, nasal congestion, loss of taste or smell)
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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.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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