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

• ClinicalTrials.gov Identifier: NCT04583189
• Recruitment Status: Completed
• First Posted: October 12, 2020
• Last Update Posted: December 2, 2020
• Sponsor: Centre Hospitalier Intercommunal Creteil
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal Creteil

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Diagnostic Test: Performance of the test antigenic and test RT-PCR	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation Des Performances du Test Rapide antigénique Covid-19 Ag BSS Chez l'Enfant Symptomatique Dans un Service d'Urgences pédiatriques
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: November 25, 2020
• Actual Study Completion Date: November 25, 2020

Arms and Interventions

Arm	Intervention/treatment
Test rapid antigenic and Test RT-PCR	Diagnostic Test: Performance of the test 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.

Outcome Measures

Primary Outcome Measures :

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 [ 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.

Secondary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Centre hospitalier intercommunal de Créteil

Créteil, France, 94010

Cabinet de ville

Nogent sur Marne, France, 94130

Cabinet Dr Cohen

Saint-Maur-des-Fossés, France

Cabinet de ville 13 Villa Beauséjour

Vincennes, France, 94300

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

More Information

• Responsible Party: Centre Hospitalier Intercommunal Creteil
• ClinicalTrials.gov Identifier: NCT04583189
• Other Study ID Numbers: SPEEDYCOVI
• First Posted: October 12, 2020
• Last Update Posted: December 2, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Intercommunal Creteil:

Performance of test

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases