Evaluation of the Performance of the Covid-19 Ag BSS Rapid Antigenic Test in Symptomatic Children in a Pediatric Emergency Department

NCT04583189 | Completed

• 1 other identifier: SPEEDYCOVI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Keywords

Performance of test

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• 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

• Comparison of the time it takes to report results between the two methods

  Through study completion up to 12 hours

Study Arms (1)

Test rapid antigenic and Test RT-PCR

OTHER

Diagnostic Test: Performance of the test antigenic and test RT-PCR

Interventions

Performance of the test antigenic and test RT-PCR DIAGNOSTIC_TEST

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.

Test rapid antigenic and Test RT-PCR

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \*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

You may not qualify if:

• Refusal of one of the parents or child to participate in the protocol

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (4)

Centre hospitalier intercommunal de Créteil

Créteil, 94010, France

Location

Cabinet de ville

Nogent-sur-Marne, 94130, France

Location

Cabinet Dr Cohen

Saint-Maur-des-Fossés, France

Location

Cabinet de ville 13 Villa Beauséjour

Vincennes, 94300, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 12, 2020
• Study Start: October 1, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

FR (4)