دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | Tonen-Wolyec, S., Dupont, R., Awaida, N., Batina-Agasa, S., Hayette, Marie-Pierre, Bélec, L. |
| المصدر: | Diagnostics, 11 (12) (2021) |
| بيانات النشر: | MDPI, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 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, Human health sciences, Laboratory medicine & medical technology, Sciences de la santé humaine, Médecine de laboratoire & technologie médicale |
| الوصف: | 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. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501 article peer reviewed |
| اللغة: | English |
| Relation: | urn:issn:2075-4418 |
| DOI: | 10.3390/diagnostics11122217 |
| URL الوصول: | https://orbi.uliege.be/handle/2268/295899 |
| حقوق: | open access http://purl.org/coar/access_right/c_abf2 info:eu-repo/semantics/openAccess |
| رقم الأكسشن: | edsorb.295899 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.3390/diagnostics11122217 |
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