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, S.; Dupont, R.; Awaida, N.; Batina-Agasa, S.; Hayette, Marie-Pierre; Bélec, L.

doi:10.3390/diagnostics11122217

Article (Scientific journals)

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, S.; Dupont, R.; Awaida, N. et al.

2021 • In Diagnostics, 11 (12)

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https://hdl.handle.net/2268/295899

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10.3390/diagnostics11122217

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Keywords :

Antigen; COVID-19; France; General public; N nucleocapsid protein; Nasal mid-turbinate secretions; Rapid diagnostic test; SARS-CoV-2; Self-test; coronavirus nucleocapsid protein; virus antigen; adult; antigen detection; Article; clinical trial; controlled study; coronavirus disease 2019; COVID-19 nucleic acid testing; COVID-19 testing; diagnostic accuracy; diagnostic test accuracy study; female; human; human tissue; lateral flow immunochromatography; major clinical study; male; mid-turbinate swab; multiplex real time polymerase chain reaction; nasopharyngeal swab; nonhuman; nose secretion; prospective study; real time reverse transcription polymerase chain reaction; reliability; satisfaction; self-testing; sensitivity and specificity; Severe acute respiratory syndrome coronavirus 2; turbinate; usability; volunteer; Youden index; young adult

Abstract :

[en] 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. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Disciplines :

Laboratory medicine & medical technology

Author, co-author :

Tonen-Wolyec, S.; Ecole Doctorale Régionale D’Afrique Centrale en Infectiologie Tropicale, Franceville, 876, Gabon, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, 2012, Congo

Dupont, R.; Laboratoire Paris XV, Paris, 75015, France

Awaida, N.; Laboratoire Paris XV, Paris, 75015, France

Batina-Agasa, S.; Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, 2012, Congo

Hayette, Marie-Pierre ; Centre Hospitalier Universitaire de Liège - CHU > > Service de microbiologie clinique

Bélec, L.; Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, and Université of Paris, Sorbonne Paris Cité, Paris, 75015, France

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English

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Publication date :

2021

Journal title :

Diagnostics

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2075-4418

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MDPI

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