{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T01:01:58Z","timestamp":1790211718383,"version":"4.1.0"},"reference-count":28,"publisher":"Walter de Gruyter GmbH","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_dx-2020-0154_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose of this study was the clinical assessment of the new Roche SARS-CoV-2 Rapid Antigen Test.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_dx-2020-0154_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test was evaluated vs. a reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from a series of consecutive patients referred for SARS-CoV-2 diagnostics to the Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over a 2-week period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_dx-2020-0154_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The final study population consisted of 321 consecutive patients (mean age, 46 years and IQR, 32\u201356 years; 181 women, 56.4%), with 149\/321 (46.4%) positive for\u00a0SARS-CoV-2 RNA via the Seegene AllplexTM2019-nCoV Assay, and 109\/321 (34.0%) positive with Roche SARS-CoV-2 Rapid Antigen Test, respectively. The overall accuracy of Roche SARS-CoV-2 Rapid Antigen Test compared to molecular testing was 86.9%, with 72.5% sensitivity and 99.4% specificity. Progressive decline in performance was observed as cycle threshold (Ct) values of different SARS-CoV-2 gene targets increased. The sensitivity was found to range between 97\u2013100% in clinical samples with Ct values &lt;25, between 50\u201381% in those with Ct values between 25 and &lt;30, but low as 12\u201318% in samples with Ct values between 30 and &lt;37.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_dx-2020-0154_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test is excellent in nasopharyngeal swabs with Ct values &lt;25, which makes it a reliable screening test in patients with high viral load. However, mass community screening would require the use of more sensitive techniques.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/dx-2020-0154","type":"journal-article","created":{"date-parts":[[2021,1,23]],"date-time":"2021-01-23T00:44:52Z","timestamp":1611362692000},"page":"322-326","source":"Crossref","is-referenced-by-count":40,"title":["Clinical assessment of the Roche SARS-CoV-2 rapid antigen test"],"prefix":"10.1515","volume":"8","author":[{"given":"Gian Luca","family":"Salvagno","sequence":"first","affiliation":[{"name":"Service of Laboratory Medicine, Pederzoli Hospital , Peschiera del Garda , Italy"},{"name":"Section of Clinical Biochemistry , University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluca","family":"Gianfilippi","sequence":"additional","affiliation":[{"name":"Chief Medical Officer, Pederzoli Hospital , Peschiera del Garda , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damiano","family":"Bragantini","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Pederzoli Hospital , Peschiera del Garda , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandon M.","family":"Henry","sequence":"additional","affiliation":[{"name":"Cardiac Intensive Care Unit, The Heart Institute, Cincinnati Children\u2019s Hospital Medical Center , Cincinnati , Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9523-9054","authenticated-orcid":false,"given":"Giuseppe","family":"Lippi","sequence":"additional","affiliation":[{"name":"Section of Clinical Biochemistry , University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2021,1,18]]},"reference":[{"key":"2025121207251121240_j_dx-2020-0154_ref_001","doi-asserted-by":"crossref","unstructured":"Lippi, G, Henry, BM, Bovo, C, Sanchis-Gomar, F. 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