- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583189
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Créteil, France, 94010
- Centre Hospitalier Intercommunal de Créteil
-
Nogent sur Marne, France, 94130
- Cabinet de ville
-
Saint-Maur-des-Fossés, France
- Cabinet Dr Cohen
-
Vincennes, France, 94300
- Cabinet de ville 13 Villa Beauséjour
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Test rapid antigenic and Test RT-PCR
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Through study completion up to 30 minutes
|
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.
|
Through study completion up to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Through study completion up to 30 minutes
|
-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
|
Through study completion up to 30 minutes
|
Comparison of the time it takes to report results between the two methods
Time Frame: Through study completion up to 12 hours
|
The difference between the time it takes to allow results between the two types of tests, based on the completion of rhino-pharyngeal tests.
|
Through study completion up to 12 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPEEDYCOVI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Performance of the test antigenic and test RT-PCR
-
QuantuMDx Group LtdPathAI; Bright Research Center; New Day DiagnosticsCompleted
-
Assiut UniversityCompletedAssess the Outcome for Children With Covid-19 Admitted in Assuit University Children HospitalEgypt
-
EDP BiotechParagon Rx Clinical, Inc.; iCura Diagnostics, LLCCompleted
-
MP Biomedicals, LLCEDP BiotechCompletedCOVID-19 | SARS-CoV2 InfectionUnited States
-
QIAGEN Gaithersburg, IncCompletedRespiratory Syncytial Virus Infections | Influenza A | Rhinovirus | Influenza B | QIAGEN ResPlex II Advanced Panel | Infection Due to Human Parainfluenza Virus 1 | Parainfluenza Type 2 | Parainfluenza Type 3 | Parainfluenza Type 4 | Human Metapneumovirus A/B | Coxsackie Virus/Echovirus | Adenovirus Types B/C/E | Coronavirus Subtypes 229E and other conditionsUnited States
-
BioTeke USA, LLCCSSi Life SciencesCompleted
-
Hospices Civils de LyonCompletedHead and Neck Cancer | Digestive Cancer | Gynaecological CancerFrance
-
Ellume Pty LtdCompletedInfluenza A | Influenza BAustralia
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingHelicobacter Pylori InfectionChina
-
Universidade Nova de LisboaRecruitingCoronavirus Infection | Pregnancy Complications | Breastfeeding | Neonatal Infection | Vertical Transmission of Infectious DiseasePortugal