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

Serge Tonen-Wolyec; Raphaël Dupont; Natalio Awaida; Salomon Batina-Agasa; Marie-Pierre Hayette; Laurent Bélec

doi:10.3390/diagnostics11122217

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

Diagnostics (Basel). 2021 Nov 27;11(12):2217. doi: 10.3390/diagnostics11122217.

Authors

Serge Tonen-Wolyec^{1

2}, Raphaël Dupont³, Natalio Awaida³, Salomon Batina-Agasa², Marie-Pierre Hayette⁴, Laurent Bélec⁵

Affiliations

¹ Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville 876, Gabon.
² Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani 2012, Congo.
³ Laboratoire Paris XV, 75015 Paris, France.
⁴ Department of Clinical Microbiology, University Hospital of Liege, 4000 Liege, Belgium.
⁵ Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, and Université of Paris, Sorbonne Paris Cité, 75015 Paris, France.

Abstract

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.

Keywords: COVID-19; France; N nucleocapsid protein; SARS-CoV-2; antigen; general public; nasal mid-turbinate secretions; rapid diagnostic test; self-test.