Evaluation of the Performance of the Covid-19 Ag BSS Rapid Antigenic Test in Symptomatic Children in a Pediatric Emergency Department
Evaluation Des Performances du Test Rapide antigénique Covid-19 Ag BSS Chez l'Enfant Symptomatique Dans un Service d'Urgences pédiatriques
研究概览
详细说明
Since March 2020, France, like the rest of the world, has been suffering from the pandemic caused by SARS CoV-2, which has led to a considerable health crisis. Moreover, the scale of this epidemic was unexpected for the scientific community and the public authorities, who in fact had to find diagnostic and management solutions for COVID-19 most often in the short term. The reference diagnosis of COVID-19 is based on the RT-PCR technique, which allows diagnosis in the early stages of infectious manifestations.
However, since the French recommendations allow widely and without prescription the access the screening of individuals in biology laboratories, regardless of age, symptoms and history of COVID-19 contage, the delays in both the completion of these RT-PCR tests and the return of their results have increased and have become incompatible with relevant decision-making by the clinician and control of the epidemic.
Indeed, since the end of August 2020, it takes about ten days to get the result of an outpatient PCR test. With the increase in the circulation of the SARS-CoV2 virus and the number of positive cases in several regions of France, the use of rapid testing for SARS CoV-2 now seems essential.
Another diagnostic method of COVID-19 is the detection of specific SARS CoV-2 antigens in rhino-pharyngeal secretions and also allows early diagnosis. The qualitative detection of specific SARS CoV-2 antigens by immunochromatography, from rhino-pharynges samples, has the advantage of offering a result in about ten minutes. These tests use specific antibodies from SARS CoV-2 to selectively detect the S protein. Initially these tests like the one developed by the Belgian firm Coris Bioconcept were developed to identify positive COVID-19 patients. Thus, they could be used as rapid screening for screening and would be an alternative to RT-PCR. Their sensitivity varies according to manufacturers and especially according to the viral load between 60% and 90% with a specificity of more than 99%. The sensitivity of this test increases in patients with a high viral load, corresponding to a Ct 25.
In this context of active circulation of the virus and with a Positivity rate in RT-PCR of about 5% in children, it was important for us to evaluate the performance of a rapid diagnostic test by antigenic detection to optimize their management
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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Créteil、法国、94010
- Centre Hospitalier Intercommunal de Créteil
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Nogent sur Marne、法国、94130
- Cabinet de ville
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Saint-Maur-des-Fossés、法国
- Cabinet Dr Cohen
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Vincennes、法国、94300
- Cabinet de ville 13 Villa Beauséjour
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
*Children under 18 years old requiring an RT-PCR Covid-19 defined according to the algorithm in force at CHI Créteil and which follows the recommendations of the GPIP and the SFP only for symptomatic children :
- Symptomatic children more then 6 years old: cough, and/or fever, and/or digestive disorders unless a diagnosis of another infectious disease is made with certainty (ex Scarlet fever, angina with AMS, enterovirus, urinary tract infections, chickenpox)
- Symptomatic children under 6 years old:
In case of hospitalization or symptoms severe enough to warrant further exploration.
Or who has had a proven contact with a COVID case. Or in contact at home with people considered at risk for SARS-CoV2 infection. Or whose symptoms do not improve after 3 days.
--Febrile children under 3 months old
- Express agreement of one of the parents present, the presence of only one of the two parents being recommanded in the current context
- Affiliated with the Social Security plan
Exclusion Criteria:
Refusal of one of the parents or child to participate in the protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 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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其他:Test rapid antigenic and Test RT-PCR
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Each patient will have 1 test rapid antigenic Biosynex Covid-19 Ag-BSS with the results in 15-20 minutes and 1 reference test RT-PCR analyzed in microbiology laboratory of the hospital.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of the performance of the Biosynex Covid-19 Ag BSS rapid antigenic test against the RT-PCR Covid-19 reference test with the AllplexTM 2019-nCoV kit (Seegene, South Korea) in children with symptoms consistent with Covid19 infection
大体时间:Through study completion up to 30 minutes
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Sensitivity of the Biosynex Covid-19 Ag BSS rapid antigenic test compared to the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit in children.
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Through study completion up to 30 minutes
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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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Sensitivity of the Biosynex Covid-19 Ag BSS rapid antigenic test compared to the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit in children.
大体时间:Through study completion up to 30 minutes
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-Calculating the entire cohort, based on the age of: Sensitivity, Specificity, Positive predictive value, Negative predictive value, Positive and negative likelihood report Biosynex Covid-19 Ag BSS fast, antigenic test compared to RT-PCR Covid-19 reference test conducted in the laboratory with the AllplexTM 2019-nCoV kit
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Through study completion up to 30 minutes
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Comparison of the time it takes to report results between the two methods
大体时间:Through study completion up to 12 hours
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The difference between the time it takes to allow results between the two types of tests, based on the completion of rhino-pharyngeal tests.
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Through study completion up to 12 hours
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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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