Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.
详细描述
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.
The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.
The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Participants must require SARS-CoV-2 testing for the following reasons:
- •COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or
- •Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or
- •Member of a group of high risk of exposure such as healthcare workers etc., or
- •Require screening for any other reason, e.g. doctor's orders, hygiene directive etc.
- •Participant must be of legal age and must be able to understand the procedure and letter of consent.
排除标准
- •Patients younger than 18 years old are excluded from the study.
- •Pregnant or breastfeeding patients are excluded from the study.
- •Patients unable to provide written informed consent are excluded.
- •Patients with bleeding disorder are excluded from the study as a precaution.
- •Hospitalized patients/inpatients are excluded.
- •Application of nasal spray within 15 min prior to testing.
- •Participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing.
- •Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.
结局指标
主要结局
Sensitivity
时间窗: Through study completion, an average of 1 1/2 month
Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)
Specificity
时间窗: Through study completion, an average of 1 1/2 month
Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)
次要结局
- Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection(Through study completion, an average of 1 1/2 month)
- Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)(Through study completion, an average of 1 1/2 month)
- Specificity in Asymptomatic Participants(Through study completion, an average of 1 1/2 month)
- Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)(Through study completion, an average of 1 1/2 month)