Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,947
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.
研究概览
简要总结
The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva, oropharyngeal swabs or nasopharyngeal swab method for specimen collection.
详细描述
The reference test to evaluate patients with suspected respiratory infection caused by virus is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a saliva specimen collection have also been accepted by the Centers for Disease Control and Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19) pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different sampling methods and the aim of this study is to compare the expected COVID-19 detection rate using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.
We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.
Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study. They will have saliva, OPS, and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2 detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be needed for the trial with 80% power at a significance level of 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteers, who are attending the COVID-19 test facilities to obtain a RT-PCR test.
- •oral and written informed consent to participate before entering the study.
排除标准
- •Failure to understand and provide informed consent.
- •Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
研究组 & 干预措施
Nasopharyngeal swab, oropharyngeal swab, and salvia collection
The participants will first be tested with nasopharyngeal swabs followed by oropharyngeal swab and saliva collection.
The collection material, virus transport medium and laboratory equipment for each method is the same in both arms
干预措施: Sequence of testing. (Diagnostic Test)
Oropharyngeal swab, salvia collection, and nasopharyngeal swab
The participants will first be tested with oropharyngeal swabs followed by saliva collection and nasopharyngeal swab.
The collection material, virus transport medium and laboratory equipment for each method is the same in both arms
干预措施: Sequence of testing. (Diagnostic Test)
Salvia collection, nasopharyngeal swab, and oropharyngeal swab
The participants will first be tested with saliva collection followed by nasopharyngeal swab and oropharyngeal swabs.
The collection material, virus transport medium and laboratory equipment for each method is the same in both arms
干预措施: Sequence of testing. (Diagnostic Test)
结局指标
主要结局
SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.
时间窗: 48 hours after testing
Due to the high specificity of RT-PCR, we will define a participant with an RT-PCR positive result from either Saliva, OPS or NPS as having a COVID-19 infection. The combined Saliva/OPS/NPS result will therefore be used as the diagnostic reference standard to calculate the sensitivity for the Saliva, OPS and NPS tests.
次要结局
- Ratio of mutations in SARS-CoV-2(48 hours after testing)
- SARS-CoV-2 RT-PCR cycle threshold (Ct) values(48 hours after testing)
- OPS, NPS and saliva test discomfort and likelihood to get retested(immediately after testing (10 minutes))
研究者
Tobias Todsen
MD, PhD, Assistant professor Tobias Todsen
Rigshospitalet, Denmark