Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,500
- 主要终点
- Monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus
研究概览
简要总结
Patients infected with SARS-CoV-2 can present with a wide range of manifestations clinical conditions, ranging from no symptoms to serious or chronic illness. The current gold standard test for the diagnosis of COVID-19 is based on a molecular test of reverse transcription polymerase chain reaction (RT-PCR), aimed at detecting the RNA of the virus in respiratory samples such as nasopharyngeal swabs or aspirates bronchial, other methods such as antigen tests and serological detection tests IgM and IgG in response to COVID-19 viral infection, can be used for the purposes of screening in the general population.
In this context of variety of existing tests, it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy, specificity and sensitivity of these tests in current clinical practice.
This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned, for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus, in terms of sensitivity, specificity, positive and negative predictive values, for the implementation of indicators quality monitoring of these kits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient over 18 years old
- •Patient coming for a biological analysis as part of the care for prevention, screening or monitoring of the pathogen target
- •Patient able to understand the information note and give a free and informed consent, on paper or digital media
- •Clinical patients:
- •Control cases (all comers or ambulatory)
- •Known positive for the pathology concerned
- •Patient hospitalized for the pathology concerned
- •Pregnant or breastfeeding patient
- •Dialysis patient
排除标准
- •Patient already included in a research protocol
- •Patient having received medication or treatment experimental or investigational during the last four weeks before collection
- •Patient subject to a legal protection measure
- •Patient affiliated with state medical aid (AME)
- •Patient not affiliated to the compulsory Social Security system
- •Refusal or inability to provide signed informed consent
- •According to the investigator, the patient is not eligible for inclusion in the study
结局指标
主要结局
Monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus
时间窗: 24 months
次要结局
未报告次要终点