{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T06:25:28Z","timestamp":1768976728664,"version":"3.49.0"},"reference-count":45,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,10,24]],"date-time":"2021-10-24T00:00:00Z","timestamp":1635033600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,10,24]],"date-time":"2021-10-24T00:00:00Z","timestamp":1635033600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Infection"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The accuracy and reliability of rapid diagnostic tests are critical for monitoring and diagnosing SARS-CoV-2 infection in the general population. This study aimed to evaluate the analytical performance of the <jats:italic>BIOSYNEX COVID-19 Ag BSS<\/jats:italic> (Biosynex Swiss SA, Fribourg, Switzerland) antigen rapid diagnostic test (<jats:italic>BIOSYNEX<\/jats:italic> Ag-RDT), which targets the SARS-CoV-2\u00a0N-nucleocapsid protein for the diagnosis of COVID-19. The Ag-RDT was compared with a real-time RT-PCR (rtRT-PCR) as gold standard for performance measurement.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Two nasopharyngeal flocked swabs were prospectively collected simultaneously in March and April 2021 from 967 individuals aged\u2009\u2265\u200918\u00a0years tested for SARS-CoV-2 in two private laboratories, Paris, France.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, the Ag-RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 81.8%, 99.6%, 96.6%, and 97.5%, respectively. The agreement (97.0%), reliability assessed using Cohen\u2019s \u03ba-coefficient (0.87), and accuracy evaluated using Youden index (J) (81.6%) in detecting SARS-CoV-2 were high. The analytical performance of the Ag-RDT remained high when there was significant viral shedding (<jats:italic>i.e.<\/jats:italic>, N gene C<jats:sub>t<\/jats:sub> values\u2009\u2264\u200933 on reference RT-PCR). The sensitivity was only 55.2% in case of low or very low viral excretion (C<jats:sub>t<\/jats:sub>\u2009&gt;\u200933).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The <jats:italic>BIOSYNEX<\/jats:italic> Ag-RDT is a promising, potentially simple diagnostic tool, especially in symptomatic COVID-19 patients with substantial viral excretion in the nasopharynx.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s15010-021-01723-5","type":"journal-article","created":{"date-parts":[[2021,10,24]],"date-time":"2021-10-24T13:02:31Z","timestamp":1635080551000},"page":"625-633","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Analytical performance of the point-of-care BIOSYNEX COVID-19 Ag BSS for the detection of SARS\u2010CoV\u20102 nucleocapsid protein in nasopharyngeal swabs: a prospective field evaluation during the COVID-19 third wave in France"],"prefix":"10.1007","volume":"50","author":[{"given":"Fr\u00e9d\u00e9ric","family":"Fitoussi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serge","family":"Tonen-Wolyec","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalio","family":"Awaida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rapha\u00ebl","family":"Dupont","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5001-0405","authenticated-orcid":false,"given":"Laurent","family":"B\u00e9lec","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,10,24]]},"reference":[{"key":"1723_CR1","doi-asserted-by":"publisher","first-page":"e59","DOI":"10.1093\/labmed\/lmaa039","volume":"51","author":"MC Smithgall","year":"2020","unstructured":"Smithgall MC, Dowlatshahi M, Spitalnik SL, Hod EA, Rai AJ. 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The authors alone are responsible for the content and the writing of the paper.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was approved by the local scientific committee of the Parc de l\u2019Innovation, Strasbourg, France (03 March 2021).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All authors approved the submission of the manuscript for publication. All participants consented to take part in this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publication"}}]}}