Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583189
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-10-01
Brief Title:
Evaluation of the Performance of the Covid-19 Ag BSS Rapid Antigenic Test in Symptomatic Children in a Pediatric Emergency Department
Sponsor:
Centre Hospitalier Intercommunal Creteil
Organization:
Centre Hospitalier Intercommunal Creteil
Study Overview
Official Title:
Evaluation Des Performances du Test Rapide antigénique Covid-19 Ag BSS Chez lEnfant Symptomatique Dans un Service dUrgences pédiatriques
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares the diagnostic performance of a nasopharyngeal swab antigenic test versus the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit Seegene South Korea in symptomatic children presenting at the hospital
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None