{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T03:11:49Z","timestamp":1787886709462,"version":"build-2784847793"},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T00:00:00Z","timestamp":1645056000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The World Health Organization (WHO) declared coronavirus disease 2019 (COVID\u201019) a pandemic in March 2020. Initially, supply chain disruptions and increased demand for testing led to shortages of critical laboratory reagents and inadequate testing capacity. Thus, alternative means of biosample collection and testing were essential to overcome these obstacles and reduce viral transmission. This study aimed to 1) compare the sensitivity and specificity of Cepheid GeneXpert<jats:sup>\u00ae<\/jats:sup> IV and BioFire<jats:sup>\u00ae<\/jats:sup> FilmArray<jats:sup>\u00ae<\/jats:sup> 2.0 next generation detection systems to detect SARS\u2010CoV\u20102, 2) evaluate the performance of both platforms using different biospecimen types, and 3) assess saline as an alternative to viral transport media (VTM) for sample collection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 1,080\u00a0specimens consisting of nasopharyngeal (NP) swabs in VTM, NP swabs in saline, nasal swabs, oropharyngeal (OP) swabs, and saliva were collected from 216 enrollees. Limit of detection (LoD) assays, NP VTM and NP saline concordance, and saliva testing were performed on the BioFire<jats:sup>\u00ae<\/jats:sup> FilmArray<jats:sup>\u00ae<\/jats:sup> 2.0 Respiratory Panel 2.1 and Cepheid GeneXpert<jats:sup>\u00ae<\/jats:sup> Xpress SARS\u2010CoV\u20102\/Flu\/RSV assays.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>LoD and comparative testing demonstrated increased sensitivity with the Cepheid compared with the BioFire<jats:sup>\u00ae<\/jats:sup> in detecting SARS\u2010CoV\u20102 in NP VTM and saline, nasal, and OP swabs. Conversely, saliva testing on the Cepheid showed statistically significant lower sensitivity compared to the BioFire<jats:sup>\u00ae<\/jats:sup>. Finally, NP swabs in saline showed no significant difference compared with NP swabs in VTM on both platforms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Cepheid and BioFire<jats:sup>\u00ae<\/jats:sup> NGDS are viable options to address a variety of public health needs providing rapid and reliable, point\u2010of\u2010care testing using a variety of clinical matrices.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24285","type":"journal-article","created":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T09:58:57Z","timestamp":1645091937000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Comparison of next generation diagnostic systems (NGDS) for the detection of SARS\u2010CoV\u20102"],"prefix":"10.1002","volume":"36","author":[{"given":"Antonio O.","family":"Sanchez","sequence":"first","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna R.","family":"Ochoa","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"},{"name":"General Dynamics Information Technology  Falls Church Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sallie L.","family":"Hall","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chet R.","family":"Voelker","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel E.","family":"Mahoney","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"},{"name":"General Dynamics Information Technology  Falls Church Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer S.","family":"McDaniel","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"},{"name":"ABSS Solutions and Services  Upper Marlboro Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"August","family":"Blackburn","sequence":"additional","affiliation":[{"name":"Science and Technology 59 Medical Wing US Air Force JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susana N.","family":"Asin","sequence":"additional","affiliation":[{"name":"Center for Advanced Molecular Detection, Science and Technology 59th Medical Wing JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3261-2805","authenticated-orcid":false,"given":"Tony T.","family":"Yuan","sequence":"additional","affiliation":[{"name":"Science and Technology 59 Medical Wing US Air Force JBSA\u2010Lackland  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,2,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-020-2012-7"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001017"},{"key":"e_1_2_9_4_1","article-title":"Severe acute respiratory syndrome\u2010related coronavirus: the species and its viruses \u2013 a statement of the Coronavirus Study Group","author":"Gorbalenya AE","year":"2020","journal-title":"bioRxiv"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-97489-9"},{"key":"e_1_2_9_6_1","unstructured":"Key actions to advance development of novel coronavirus medical countermeasures [press release]. January 27 2020 2020."},{"key":"e_1_2_9_7_1","unstructured":"Policy for coronavirus disease\u20102019 tests during the public health emergency (Revised) [press release]. May 2020 2020."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2307\/2529310"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.32614\/RJ-2014-009"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anorl.2020.06.001"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pathol.2020.09.013"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiaa272"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01438-20"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00228-20"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3390\/diseases9020038"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2020.05.001"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24285","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.24285","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24285","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T23:21:07Z","timestamp":1693005667000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24285"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,17]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,4]]}},"alternative-id":["10.1002\/jcla.24285"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24285","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,17]]},"assertion":[{"value":"2021-12-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-17","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24285"}}