{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T11:00:40Z","timestamp":1780743640117,"version":"3.54.1"},"reference-count":45,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2022,12,22]],"date-time":"2022-12-22T00:00:00Z","timestamp":1671667200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"the Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-006726"],"award-info":[{"award-number":["INV-006726"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>The Xpert\u00ae Xpress SARS-CoV-2 and Xpert\u00ae Xpress SARS-CoV-2\/Flu\/RSV tests were rapidly developed and widely used during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. In response to emerging genetic variability, a new SARS-CoV-2 target (RNA-dependent RNA-polymerase) has been added to both tests: Xpert\u00ae Xpress CoV-2 plus and Xpert\u00ae Xpress CoV-2\/Flu\/RSV plus test. A rapid evaluation of both tests was performed in South Africa, using residual respiratory specimens. Residual respiratory specimens (n = 125) were used to evaluate the Xpert\u00ae Xpress CoV-2 plus test and included 50 genotyped specimens. The Xpert\u00ae Xpress CoV-2\/Flu\/RSV plus test was assessed using 45 genotyped SARS-CoV-2 specimens, 10 influenza A, 10 influenza B and 20 respiratory syncytial virus specimens. Results were compared to in-country standard-of-care tests. Genotyped specimens tested the performance of the test under pressure from circulating SARS-CoV-2 variants of concern. Reference material was included to assess the test limits and linearity. The Xpert\u00ae Xpress CoV-2 plus test performance compared to reference results across residual respiratory specimens was good (positive percentage agreement (PPA) = 95.2%, negative percentage agreement (NPA) = 95.0%) The Xpert\u00ae Xpress CoV-2\/Flu\/RSV plus test showed good performance across all residual respiratory specimens (PPA = 100%, NPA = 98.3%). All genotyped variants of concern were detected by both tests. The Xpert\u00ae Xpress CoV-2 plus and Xpert\u00ae Xpress CoV-2\/Flu\/RSV plus tests can be used to diagnose SARS-CoV-2, and to diagnose and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus, respectively. The NPA was lower than the recommended 99%, but was influenced by the low number of negative specimens tested. The variants of concern assessed did not affect test performance. It is recommended that sites perform their own assessments compared to in-country standard-of-care tests.<\/jats:p>","DOI":"10.3390\/diagnostics13010034","type":"journal-article","created":{"date-parts":[[2022,12,23]],"date-time":"2022-12-23T02:36:46Z","timestamp":1671763006000},"page":"34","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Rapid Evaluation of the Xpert\u00ae Xpress CoV-2 plus and Xpert\u00ae Xpress CoV-2\/Flu\/RSV plus Tests"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4661-9023","authenticated-orcid":false,"given":"Lara Dominique","family":"Noble","sequence":"first","affiliation":[{"name":"WITS Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley Erica","family":"Scott","sequence":"additional","affiliation":[{"name":"WITS Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riffat","family":"Munir","sequence":"additional","affiliation":[{"name":"WITS Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9186-0679","authenticated-orcid":false,"given":"Mignon","family":"Du Plessis","sequence":"additional","affiliation":[{"name":"Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases, Division of the National Health Laboratory Service, Johannesburg 2192, South Africa"},{"name":"School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Steegen","sequence":"additional","affiliation":[{"name":"School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"},{"name":"National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0330-4857","authenticated-orcid":false,"given":"Lucia","family":"Hans","sequence":"additional","affiliation":[{"name":"School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"},{"name":"National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Puleng","family":"Marokane","sequence":"additional","affiliation":[{"name":"National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9869-5271","authenticated-orcid":false,"given":"Pedro","family":"Da Silva","sequence":"additional","affiliation":[{"name":"National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy Susan","family":"Stevens","sequence":"additional","affiliation":[{"name":"WITS Diagnostic Innovation Hub, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, South Africa"},{"name":"National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,12,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1056\/NEJMoa2001017","article-title":"A Novel Coronavirus from Patients with Pneumonia in China, 2019","volume":"382","author":"Zhu","year":"2020","journal-title":"N. 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