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

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.

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

“…To determine if nasal samples have an equivalent detection ability to nasopharyngeal samples with RAT, we also included 115 papers that employ nasopharyngeal swabs ( Table S2 ). Among the 49 studies on nasal swabs containing 79,073 samples [ [2] , [3] , [4] , 6 , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ], all of them were published between 2021 and 2022, and twenty-one studies were conducted in the USA [ 12 , 14 , 15 , 18 , 21 , 22 , [25] , [26] , [27] , [32] , [33] , [34] , [35] ...…”

“…In addition to eliminating the drawbacks of nasopharyngeal swabs in terms of causing discomfort and possibly even damage to the patient [ 56 ], nasal swabs offered the option of home testing. Questionnaires were conducted in several studies, resulting that nearly all patients reported no pain in the anterior nasal collection, and it was easy to understand how to perform self-testing and interpret the test results [ 3 , 4 , 6 , 47 , 53 , 57 ]. Previous experience with HIV self-testing demonstrated that self-testers could perform HIV rapid diagnostic tests with reliability and accuracy [ 58 ].…”

“…The drawbacks of PCR, such as delays in obtaining results, and the necessity for pricey laboratory equipment as well as trained healthcare personnel, make it unsuitable for application in large screening programs [ 2 ]. Therefore, the rapid antigen test (RAT), with its short turnaround time and low cost, offers a rapid and easy-to-perform alternative to SARS-CoV-2 detection [ 3 , 4 ].…”

“…Nasal swabs, less invasive than nasopharyngeal swabs, represent a more comfortable approach to sampling [ 5 ]. They do not require skilled professionals, providing the basis for their use as a self-sampling technique [ 3 ]. Widespread use of self-testing for SARS-CoV-2 infection, which could help reduce the workload of healthcare workers, can be a useful supplement to point-of-care tests by enabling more wide-ranging testing.…”

Lateral flow test engineering and lessons learned from COVID-19

“…3a). Self-tests have been used in population surveillance studies, such as the Real-time Assessment of Community Transmission (REACT)-2 study in the UK 27 , and have been widely accepted and preferred for selftesting in Europe and the USA [28][29][30] , demonstrating safe and error-free use, as well as correct interpretation of results [31][32][33][34] . In low-and middle-income regions, COVID-19 self-tests have also shown high acceptability 35,36 and close agreement between results from professional use and self-testing (in Malawi and Zimbabwe) 7 , mirroring earlier findings by the Self-Testing Africa (STAR) initiative on HIV self-testing 37 .…”