Diagnostic Accuracy of Self-collected Versus Healthcare Collected Anterior Nose Swabs for SARS-CoV-2 Detection - a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,070
- 试验地点
- 1
- 主要终点
- Sensitivity of the self-collected rapid antigen test compared to healthcare collected test
研究概览
简要总结
The current Coronavirus Disease 2019 (COVID-19) pandemic continues to be a worldwide health emergency. To contain the spread of disease, high demands on testing availability and capacity are observed. Although polymerase chain reaction (PRC) is the golden standard method in detecting infection with COVID-19, the procedure is time consuming and requires healthcare personnel and laboratories. Rapid antigen tests, however, have several potential benefits including greater scalability and results are provided much quicker. So far, sampling for rapid antigen tests is predominantly performed by health care personnel. Though, the testing and analyzing procedure of an antigen test seems manageable by laymen but the validity of a self-performed rapid antigen test is sparsely examined. Thus, the investigators wish to conduct a study evaluating the diagnostic accuracy of self-performed rapid antigen test for detecting COVID-19 infection by comparing self-performed and healthcare-performed rapid antigen tests on the same individual while using a PCR tests as a control.
详细描述
Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic continue to be a worldwide health emergency resulting in national lockdown.
A strategy for the opening of society has been proposed to be extensive testing.
The golden standard for correct detection of SARS-CoV-2 is by reverse transcriptase polymerase chain reaction (RT-PCR) of an upper respiratory specimen. However, this requires laboratory facilities and the test is time-consuming. Rapid antigen tests offer a simpler approach, and test results are available within minutes. Especially the latter can potentially lead to a faster containment of infection in the society. So far, the specimens for the rapid antigen test have primarily been collected by nasopharyngeal swabs by trained personnel.
Self-collected swab offers a possibility to increase testing access and would enable testing outside the healthcare system. Furthermore, self-collected swabs could lower the exposure risk of healthcare workers and could reduce the expenses for personal protective equipment, and lastly self-collection is furthermore reported as the preferred sampling method. However, self-collected swabs may pose issues of increased risk of incorrect sampling as sampling is unsupervised and the sensitivity of the self-collected tests compared to professional-collected tests has been questioned due to varying results. Studies on the rapid antigen test and self-collected swabs as a screening tool are sparse.
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
- 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
- •Age ≥ 16 years
- •Having a scheduled appointment for a COVID-19 test at one of the test centers run by Testcenter Danmark in the Capital Region
排除标准
- •Non-fluent in Danish
- •Impaired citizen i.e. not capable of an independent self-testing
- •Neck breathers (Tracheostomy/laryngectomy patients)
- •Nasopharyngeal or oropharyngeal anomalies disallowing sampling using swabs
研究组 & 干预措施
Self-collection of specimen
Participants allocated to this arm will perform specimen collection for the antigen tests independently using written instructions and access to a video. Sampling is performed as two individual procedures from the anterior part of the nose and the oropharynx respectively.
干预措施: Collection of nasal and oropharyngeal specimen for COVID19 antigen test (Diagnostic Test)
Healthcare-collection of specimen
Participants allocated to this arm will initially have specimen collection for the antigen tests done by a healthcare personnel. Sampling is performed as two individual procedures from the anterior part of the nose and the oropharynx respectively.
干预措施: Collection of nasal and oropharyngeal specimen for COVID19 antigen test (Diagnostic Test)
结局指标
主要结局
Sensitivity of the self-collected rapid antigen test compared to healthcare collected test
时间窗: 48 hours from sampling to results of RT-PCR analysis
This applies to both specimen from the anterior part of the nose and from the oropharynx
次要结局
- Diagnostic accuracy including sensitivity and specificity of self-collected and healthcare collected rapid antigen test to RT-PCR tests collected by health care personnel(30 minutes from sampling to results of the two rapid antigen tests)
研究者
Kathrine Kronberg Jakobsen
MD
Rigshospitalet, Denmark