Cargando…

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freibur...

Descripción completa

Detalles Bibliográficos
Autores principales: Tonen-Wolyec, Serge, Dupont, Raphaël, Awaida, Natalio, Batina-Agasa, Salomon, Hayette, Marie-Pierre, Bélec, Laurent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700066/
https://www.ncbi.nlm.nih.gov/pubmed/34943454
http://dx.doi.org/10.3390/diagnostics11122217
_version_ 1784620666544193536
author Tonen-Wolyec, Serge
Dupont, Raphaël
Awaida, Natalio
Batina-Agasa, Salomon
Hayette, Marie-Pierre
Bélec, Laurent
author_facet Tonen-Wolyec, Serge
Dupont, Raphaël
Awaida, Natalio
Batina-Agasa, Salomon
Hayette, Marie-Pierre
Bélec, Laurent
author_sort Tonen-Wolyec, Serge
collection PubMed
description Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France.
format Online
Article
Text
id pubmed-8700066
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-87000662021-12-24 Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France Tonen-Wolyec, Serge Dupont, Raphaël Awaida, Natalio Batina-Agasa, Salomon Hayette, Marie-Pierre Bélec, Laurent Diagnostics (Basel) Article Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France. MDPI 2021-11-27 /pmc/articles/PMC8700066/ /pubmed/34943454 http://dx.doi.org/10.3390/diagnostics11122217 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Tonen-Wolyec, Serge
Dupont, Raphaël
Awaida, Natalio
Batina-Agasa, Salomon
Hayette, Marie-Pierre
Bélec, Laurent
Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title_full Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title_fullStr Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title_full_unstemmed Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title_short Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France
title_sort evaluation of the practicability of biosynex antigen self-test covid-19 ag+ for the detection of sars-cov-2 nucleocapsid protein from self-collected nasal mid-turbinate secretions in the general public in france
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700066/
https://www.ncbi.nlm.nih.gov/pubmed/34943454
http://dx.doi.org/10.3390/diagnostics11122217
work_keys_str_mv AT tonenwolyecserge evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance
AT dupontraphael evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance
AT awaidanatalio evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance
AT batinaagasasalomon evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance
AT hayettemariepierre evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance
AT beleclaurent evaluationofthepracticabilityofbiosynexantigenselftestcovid19agforthedetectionofsarscov2nucleocapsidproteinfromselfcollectednasalmidturbinatesecretionsinthegeneralpublicinfrance