{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T19:03:03Z","timestamp":1791831783195,"version":"4.3.4"},"reference-count":16,"publisher":"American Society for Microbiology","issue":"3","license":[{"start":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T00:00:00Z","timestamp":1741046400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T00:00:00Z","timestamp":1741046400000},"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":["Microbiol Spectr"],"published-print":{"date-parts":[[2025,3,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Timely diagnosis of SARS-CoV-2 is important for infection control and treatment. Real-time reverse transcriptase PCR (rRT-PCR) tests are the reference standard for diagnosis but often require a centralized laboratory, making them time-intensive and unsuitable for resource-limited settings. The Abbott ID NOW\u2122 COVID-19 2.0 assay is a rapid point-of-care (POC), isothermal molecular test for qualitative detection of SARS-CoV-2. We prospectively evaluated its clinical performance against three reference rRT-PCR tests: Hologic Panther Fusion, Roche Cobas, and CDC 2019-nCoV RT-PCR Diagnostic Panel. Investigators enrolled 3,530 subjects, with 3,146 evaluable. In symptomatic subjects (\n                      <jats:italic>n<\/jats:italic>\n                      = 914), the test showed a positive percent agreement (PPA) of 91.7% (95% confidence interval [CI]: 87.8, 94.4) and a negative percent agreement (NPA) of 98.4% (95% CI: 97.1, 99.1). The PPA improved with lower cycle threshold (Ct) values: 94.7% (95% CI: 91.2, 97.2) for Ct \u226436, 97.6% (95% CI: 94.5, 99.2) for Ct \u226433, and 99.4% (95% CI: 96.8, 100.0) for Ct \u226430. Discordant results were observed among the three reference rRT-PCR tests across evaluable subjects with suspected COVID-19 infection. For 1,630 cases of symptomatic and asymptomatic subjects suspected of COVID-19, where all three rRT-PCR methods were evaluable, CDC test results differed the most, with 144 discordant results with Roche and 119 with Panther rRT-PCR tests. Roche and Panther test results differed in 67 cases. In summary, the Abbott ID NOW\u2122 COVID-19 2.0 assay can serve as a valuable diagnostic tool in acute symptomatic subjects in point-of-care settings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      The Abbott ID NOW\n                      <jats:sup>TM<\/jats:sup>\n                      COVID-19 2.0 assay is a suitable rapid test for diagnosing COVID-19 in acute symptomatic subjects and can be used in point-of-care settings and low-resource settings. With results reported in 12 minutes or less, Abbott ID NOW\n                      <jats:sup>TM<\/jats:sup>\n                      COVID-19 2.0 facilitates timely diagnosis, enabling linkage to appropriate antiviral medication.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.02033-24","type":"journal-article","created":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T09:00:45Z","timestamp":1739264445000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":8,"title":["Clinical performance of Abbott ID NOW\u2122 COVID-19 2.0 rapid molecular point-of-care test compared to three real-time RT-PCR assays"],"prefix":"10.1128","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3679-9681","authenticated-orcid":true,"given":"Maria D.","family":"Iglesias-Ussel","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine","place":["Durham, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleah","family":"Bowie","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine","place":["Durham, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack G.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine","place":["Durham, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"Li","sequence":"additional","affiliation":[{"name":"Abbott Rapid Diagnostics, a Division of Abbott Laboratories","place":["San Diego, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence P.","family":"Park","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine","place":["Durham, USA"]},{"name":"Duke Global Health Institute, Duke University","place":["Durham, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose F.","family":"Cardona","sequence":"additional","affiliation":[{"name":"Indago Research and Health Center Inc","place":["Hialeah, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Dennis","sequence":"additional","affiliation":[{"name":"DelRicht Research","place":["New Orleans, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentine","family":"Ebuh","sequence":"additional","affiliation":[{"name":"Global Medical Research LLC","place":["Dallas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven A.","family":"Geller","sequence":"additional","affiliation":[{"name":"Centennial Medical Group","place":["Elkridge, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish","family":"Jain","sequence":"additional","affiliation":[{"name":"Great Lakes Clinical Trials","place":["Chicago, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark M.","family":"McKenzie","sequence":"additional","affiliation":[{"name":"WR - ClinSearch, LLC","place":["Chattanooga, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kian","family":"Merchant-Borna","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, University of Rochester School of Medicine and Dentistry","place":["Rochester, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anand","family":"Patel","sequence":"additional","affiliation":[{"name":"Conquest Research LLC","place":["Winter Park, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Siegel","sequence":"additional","affiliation":[{"name":"MediSync Clinical Research LLC","place":["Austin, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guy S.","family":"Strauss","sequence":"additional","affiliation":[{"name":"Multi-Specialty Research Associates Inc","place":["Lake City, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joby J.","family":"Thoppil","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, The University of Texas Southwestern Medical Center","place":["Dallas, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S.","family":"Weinberg","sequence":"additional","affiliation":[{"name":"Carbon Health Technologies Inc.& Carbon Health Medical Group","place":["Oakland, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher W.","family":"Woods","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine","place":["Durham, USA"]},{"name":"Duke Global Health Institute, Duke University","place":["Durham, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.3390\/biom10091312"},{"key":"e_1_3_3_3_2","unstructured":"WHO director-general\u2019s opening remarks at the media briefing on COVID-19. 2020. https:\/\/www.who.int\/director-general\/speeches\/detail\/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1177\/2632010X241228053"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02346-1"},{"key":"e_1_3_3_6_2","unstructured":"Who is at high risk for severe coronavirus disease? 2024. Johns Hopkins Medicine. Available from: https:\/\/www.hopkinsmedicine.org\/health\/conditions-and-diseases\/coronavirus\/coronavirus-and-covid19-who-is-at-higher-risk"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013705.pub3"},{"key":"e_1_3_3_8_2","unstructured":"Abbott point of care. 2024. Available from: https:\/\/www.globalpointofcare.abbott\/us\/en\/product-details\/id-now.html. Retrieved 5 Dec 2024."},{"key":"e_1_3_3_9_2","unstructured":"Abbott. 2023. Predicted impact of variants on Abbott\u2019s SARS-CoV-2\/COVID-19 diagnostic tests-technical brief"},{"key":"e_1_3_3_10_2","unstructured":"Interim guidelines for collecting and handling of clinical specimens for COVID-19 testing | COVID-19 | CDC. 2024. Available from: https:\/\/www.cdc.gov\/covid\/hcp\/clinical-care\/clinical-specimen-guidelines.html. Retrieved 5 Dec 2024."},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m3862"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2666-5247(20)30172-5"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiab107"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2008457"},{"key":"e_1_3_3_15_2","unstructured":"Nucleic acid amplification testing (e.g. RT-PCR). 2023. Available from: https:\/\/www.idsociety.org\/covid-19-real-time-learning-network\/diagnostics\/RT-pcr-testing"},{"key":"e_1_3_3_16_2","unstructured":"Real-time PCR: understanding Ct - US."},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.32.2001483"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02033-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02033-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T09:10:10Z","timestamp":1741079410000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.02033-24"}},"subtitle":[],"editor":[{"given":"Alexander","family":"Bello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,3,4]]},"references-count":16,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3,4]]}},"alternative-id":["10.1128\/spectrum.02033-24"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.02033-24","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,4]]},"assertion":[{"value":"2024-08-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e02033-24"}}