- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Créteil, Francia, 94010
- Centre Hospitalier Intercommunal de Creteil
-
Nogent sur Marne, Francia, 94130
- Cabinet de ville
-
Saint-Maur-des-Fossés, Francia
- Cabinet Dr Cohen
-
Vincennes, Francia, 94300
- Cabinet de ville 13 Villa Beauséjour
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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.
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SPEEDYCOVI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Covid19
-
Ricardo Pereira MestreInstitute of Oncology Research (IOR); Istituto Cantonale di PatologiaCompletato
-
Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReNAttivo, non reclutante
-
Inmunova S.A.Hospital Italiano de Buenos Aires; Laboratorio Elea Phoenix S.A.; Hospital de Campaña... e altri collaboratoriCompletato
-
Manchester University NHS Foundation TrustUniversity of ManchesterCompletato
-
Rush University Medical CenterHospital Civil de GuadalajaraCompletatoCovid19Stati Uniti, Messico
-
Evelyne D.TrottierCompletato
-
Sinovac Research and Development Co., Ltd.Completato
-
Mabwell (Shanghai) Bioscience Co., Ltd.Shanghai Public Health Clinical CenterCompletato
-
Erasmus Medical CenterUniversity Medical Center Groningen; Academisch Medisch Centrum - Universiteit... e altri collaboratoriReclutamento
Prove cliniche su Performance of the test antigenic and test RT-PCR
-
QuantuMDx Group LtdPathAI; Bright Research Center; New Day DiagnosticsCompletato
-
Centre Hospitalier Sud EssonneSconosciuto
-
Assiut UniversityCompletatoValutare l'esito per i bambini con Covid-19 ricoverati nell'ospedale pediatrico universitario AssuitEgitto
-
MP Biomedicals, LLCEDP BiotechCompletatoCOVID-19 | Infezione da SARS-CoV2Stati Uniti
-
EDP BiotechParagon Rx Clinical, Inc.; iCura Diagnostics, LLCCompletatoCOVID-19 | Infezione da SARS-CoV-2Stati Uniti
-
QIAGEN Gaithersburg, IncCompletatoInfezioni da virus respiratorio sinciziale | Influenza A | Rinovirus | Influenza B | Pannello avanzato QIAGEN ResPlex II | Infezione dovuta al virus della parainfluenza umana 1 | Parainfluenza di tipo 2 | Parainfluenza di tipo 3 | Parainfluenza di tipo 4 | Metapneumovirus umano A/B | Virus Coxsackie/Echovirus | Adenovirus di tipo B/C... e altre condizioniStati Uniti
-
Centre Hospitalier Universitaire VaudoisCompletato
-
BioTeke USA, LLCCSSi Life SciencesCompletato
-
King Fahad Specialist Hospital DammamSconosciutoCOVID 19Arabia Saudita
-
Universidade Nova de LisboaReclutamentoInfezione da coronavirus | Complicazioni della gravidanza | Allattamento al seno | Infezione neonatale | Trasmissione verticale di malattie infettivePortogallo