{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T14:06:39Z","timestamp":1790172399249,"version":"4.1.0"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T00:00:00Z","timestamp":1626048000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T00:00:00Z","timestamp":1626048000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This report describes a manufacturer\u2010independent evaluation of the diagnostic accuracy of the Elecsys SARS\u2010CoV\u20102 antigen assay from Roche Diagnostics in a tertiary care setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this single\u2010center study, we used nasopharyngeal swabs from 403 cases from the emergency department and intensive care unit of our hospital. The reference standard for detecting SARS\u2010CoV\u20102 was the reverse\u2010transcription polymerase chain reaction (RT\u2010PCR) assay. Cycle threshold (Ct) values were recorded for positive RT\u2010PCR assays. The index test was the Elecsys SARS\u2010CoV\u20102 antigen assay. This electrochemiluminescence immunoassay produces results as cutoff index (COI) values, with values \u22651.00 being reported as positive.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 403 cases, 47\u00a0showed positive results in RT\u2010PCR assays. Of the 47 RT\u2010PCR\u2010positive cases, 12\u00a0showed positive results in the antigen assay. Of the 356 RT\u2010PCR\u2010negative cases, all showed negative results in the antigen assay. Thus, the antigen assay showed a sensitivity of 26% (95% CI, 14%\u201040%) and specificity of 100% (95% CI, 99%\u2010100%). Analysis of the relationship between Ct values and COI values in the 47 RT\u2010PCR\u2010positive cases showed a correlation coefficient of \u22120.704 (95% CI, \u22120.824 to \u22120.522). The true\u2010positive rate of the antigen assay for Ct values of 15\u201324.9, 25\u201329.9, 30\u201334.9, and 35\u201339.9 was 100%, 44%, 8%, and 6%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Elecsys SARS\u2010CoV\u20102 antigen assay has a low sensitivity for detecting SARS\u2010CoV\u20102 from nasopharyngeal swabs. Hence, we decided to not use this assay in the clinical routine of our hospital.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.23906","type":"journal-article","created":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T05:16:25Z","timestamp":1626066985000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Diagnostic performance of the Elecsys SARS\u2010CoV\u20102 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single\u2010center evaluation"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5095-3964","authenticated-orcid":false,"given":"Thomas","family":"Mueller","sequence":"first","affiliation":[{"name":"Department of Clinical Pathology Hospital of Bolzano Bolzano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Kompatscher","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Intensive Care Medicine Hospital of Bolzano Bolzano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"La Guardia","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Bolzano Hospital Bolzano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1159\/000515343"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102020\u20101412"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/v12060582"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1515\/dx\u20102020\u20100131"},{"issue":"1","key":"e_1_2_10_6_1","first-page":"S49","article-title":"Limit of blank, limit of detection and limit of quantitation","volume":"29","author":"Armbruster DA","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"e_1_2_10_7_1","volume-title":"Evaluation of the linearity of quantitative measurement procedures: a statistical approach; 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