{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T01:58:51Z","timestamp":1768442331467,"version":"3.49.0"},"reference-count":17,"publisher":"American Society for Microbiology","issue":"12","license":[{"start":{"date-parts":[[2024,12,11]],"date-time":"2024-12-11T00:00:00Z","timestamp":1733875200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,12,11]],"date-time":"2024-12-11T00:00:00Z","timestamp":1733875200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,12,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues its largely aseasonal spread with millions of cases per year. Highly sensitive, point-of-care testing is critical for rapid detection of coronavirus disease 2019 (COVID-19) cases and initiation of antiviral therapy to avert adverse health outcomes and reduce onward transmission of the virus. While hundreds of COVID-19 diagnostics received emergency use authorization from the FDA during the pandemic, significantly fewer have navigated the course to FDA clearance or approval. Here, we determined the clinical performance of the Cepheid Xpert Xpress CoV-2\n              <jats:italic>plus<\/jats:italic>\n              for detection of SARS-CoV-2 in 3,750 anterior nasal swab (NS) specimens and nasopharyngeal swab (NPS) from 32 sites in comparison to the FDA-authorized BioFire Respiratory Panel 2.1. Three-quarters of specimens collected were tested on the Xpert Xpress CoV-2\n              <jats:italic>plus<\/jats:italic>\n              in the point-of-care setting. Overall positive percent agreement (PPA) was 98.1% (95% CI: 96.7%\u201398.9%) and negative percent agreement (NPA) was 98.3% (97.7%\u201398.7%). Performance of the Xpert Xpress CoV-2\n              <jats:italic>plus<\/jats:italic>\n              was slightly improved in NS compared to NPS specimens, with PPA of 99.3% versus 97.0% (Fisher\u2019s exact test,\n              <jats:italic>P<\/jats:italic>\n              = 0.06) and NPA of 98.3% versus 98.2% (\n              <jats:italic>P<\/jats:italic>\n              = 0.89), respectively. Assay PPA was similar between untrained and trained users (98.7% vs 97.3%,\n              <jats:italic>P<\/jats:italic>\n              = 0.75), while NPA was slightly improved for untrained users (99.0% vs 97.6%,\n              <jats:italic>P<\/jats:italic>\n              = 0.0003). This study showed that Cepheid Xpert Xpress COV-2\n              <jats:italic>plus<\/jats:italic>\n              is highly sensitive and specific\/has high PPA and NPA for detection of SARS-CoV-2 from both NS and NPS specimens.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>\n              Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause millions of infections and tens of thousands of deaths per year in the United States. While the FDA authorized hundreds of SARS-CoV-2 tests during the public health emergency, significantly fewer have made the transition to being cleared or approved. There continues to be a need for FDA-authorized point-of-care SARS-CoV-2 testing that can be performed by untrained users. We conducted a large prospective study of the Cepheid Xpert Xpress CoV-2\n              <jats:italic>plus<\/jats:italic>\n              test for detection of SARS-CoV-2 in both nasal and nasopharyngeal swabs by trained and untrained users. The assay demonstrated excellent clinical performance characteristics and, as a result of this study, was cleared by the FDA.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.01219-24","type":"journal-article","created":{"date-parts":[[2024,11,6]],"date-time":"2024-11-06T14:00:18Z","timestamp":1730901618000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2\n            <i>plus<\/i>\n            test on nasal and nasopharyngeal swabs"],"prefix":"10.1128","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7443-0527","authenticated-orcid":true,"given":"Alexander L.","family":"Greninger","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington","place":["Seattle, USA"]},{"name":"Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center","place":["Seattle, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allan","family":"Larcena","sequence":"additional","affiliation":[{"name":"Slidell Internal Medicine Clinic","place":["Slidell, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amrish","family":"Patel","sequence":"additional","affiliation":[{"name":"Innovo Research - Piedmont Healthcare","place":["Troutman, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Webster","sequence":"additional","affiliation":[{"name":"Innovo Research - Wilmington Health","place":["Wilmington, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christina","family":"Ulen","sequence":"additional","affiliation":[{"name":"Advanced Pediatrics","place":["Vienna, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dallas F.","family":"Green","sequence":"additional","affiliation":[{"name":"AHF - The Kinder Medical Group","place":["Miami, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dana","family":"King","sequence":"additional","affiliation":[{"name":"University of Iowa Hospitals and Clinics","place":["Iowa City, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepesh Rubin","family":"Patel","sequence":"additional","affiliation":[{"name":"Patient Plus Urgent Care - Southdowns","place":["Baton Rouge, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3959-2583","authenticated-orcid":true,"given":"Erin","family":"McElvania","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Endeavor Health","place":["Evanston, USA"]},{"name":"Department of Pathology, University of Chicago, Pritzker School of Medicine","place":["Chicago, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Glenn","family":"Harnett","sequence":"additional","affiliation":[{"name":"No Resistance Consulting Group","place":["Birmingham, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imad","family":"Jandali","sequence":"additional","affiliation":[{"name":"ASCLEPES Research Centers","place":["Brooksville, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Gibson","sequence":"additional","affiliation":[{"name":"UCF Student Health Services","place":["Orlando, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Killion","sequence":"additional","affiliation":[{"name":"McFarland Clinic - PC","place":["Ames, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jibran","family":"Atwi","sequence":"additional","affiliation":[{"name":"MedPharmics LLC","place":["Lafayette, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly","family":"Bergmann","sequence":"additional","affiliation":[{"name":"Children\u2019s of Minnesota","place":["Minneapolis, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lance","family":"Slade","sequence":"additional","affiliation":[{"name":"Meridian Clinical Research LLC","place":["Macon, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Allen Staat","sequence":"additional","affiliation":[{"name":"Cincinnati Children\u2019s Hospital and Medical Center","place":["Cincinnati, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Faron","sequence":"additional","affiliation":[{"name":"Froedtert & the Medical College of Wisconsin Hospitals and Health Partners","place":["Milwaukee, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megan","family":"Washington","sequence":"additional","affiliation":[{"name":"TrustCare I-55","place":["Jackson, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Patel","sequence":"additional","affiliation":[{"name":"Meridian Clinical Research LLC","place":["Rockville, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajasekaran","family":"Annamalai","sequence":"additional","affiliation":[{"name":"PCP for Life-Tidwell","place":["Houston, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald","family":"Ackerman","sequence":"additional","affiliation":[{"name":"Comprehensive Clinical Research LLC","place":["West Palm Beach, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"III","given":"William P.","family":"Stewart","sequence":"additional","affiliation":[{"name":"Ford, Simpson, Lively & Rice Pediatrics PLLC","place":["Winston-Salem, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuliet Mora","family":"Amador","sequence":"additional","affiliation":[{"name":"Santa Clara Family Clinic","place":["Houston, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepa","family":"Rao","sequence":"additional","affiliation":[{"name":"Cepheid","place":["Sunnyvale, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaohong","family":"Liu","sequence":"additional","affiliation":[{"name":"Cepheid","place":["Sunnyvale, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aarthi","family":"Raman","sequence":"additional","affiliation":[{"name":"Cepheid","place":["Sunnyvale, USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00821-20"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00783-20"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00772-20"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00926-20"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104428"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.coviro.2021.05.007"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-13995-4"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2022.115699"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/Spectrum.01494-21"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.01355-22"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics13010034"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104538"},{"key":"e_1_3_4_14_2","volume-title":"Evaluation of automatic class III designation for biofire respiratory panel 2.1 decision summary","author":"BioFire Diagnostics, LLC","unstructured":"BioFire Diagnostics, LLC. Evaluation of automatic class III designation for biofire respiratory panel 2.1 decision summary. Food and Drug Administraton."},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7218a3"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2023.08.005"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","unstructured":"Papenburg J Campbell JR Caya C Dion C Corsini R Cheng MP Menzies D Yansouni CP. 2022. Adequacy of serial self-performed SARS-CoV-2 rapid antigen-detection testing for longitudinal mass screening in the workplace. 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