{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T21:44:35Z","timestamp":1789767875594,"version":"4.0.1"},"reference-count":22,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T00:00:00Z","timestamp":1754352000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T00:00:00Z","timestamp":1754352000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Roche Diagnostics Korea","award":["-"],"award-info":[{"award-number":["-"]}]},{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"publisher","award":["RS-2024-00332244"],"award-info":[{"award-number":["RS-2024-00332244"]}],"id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2025,8,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>Accurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A\/B are crucial for effective clinical management and infection control. In the present study, we evaluated the cobas SARS-CoV-2 &amp; Influenza A\/B v2 assay (Roche Diagnostics, Basel, Switzerland) using the Roche cobas 5800 system, comparing it to the Allplex SARS-CoV-2\/FluA\/FluB\/RSV assay (Seegene, Seoul, Republic of Korea). A total of 871 nasopharyngeal swab specimens, including 164 SARS-CoV-2-positive, 76 influenza A-positive, 77 influenza B-positive, and 554 negative specimens, were tested using the cobas and Allplex assays in parallel. The positive percent agreement and negative percent agreement between the cobas and Allplex assays were 100% and 98.3% for SARS-CoV-2, 100% and 99.1% for influenza A, and 100% and 99.3% for influenza B, respectively. Cohen\u2019s kappa values ranged from 0.95 to 0.96, indicating almost perfect agreement. The limits of detection for SARS-CoV-2 E and open reading frame 1ab genes, influenza A, and influenza B were 25.3, 12.4, 16.1, and 11.0 copies\/mL, respectively. No cross-reactivity was observed with 29 non-target respiratory pathogens. These findings demonstrate that the cobas assay reliably detects SARS-CoV-2 and influenza A\/B with high sensitivity and specificity. Notably, this assay enables high-throughput automated workflows, facilitating timely decision-making during SARS-CoV-2 and influenza cocirculation.<\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>Accurate and rapid diagnostic assays that simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A\/B are essential for effective clinical management and infection control. This study demonstrates that the cobas SARS-CoV-2 &amp; Influenza A\/B v2 assay reliably detects SARS-CoV-2 and influenza A\/B with high sensitivity and specificity. Designed for use on the cobas 5800\/6800\/8800 systems, this assay supports high-throughput automated workflows, enabling timely decision-making during periods of high testing demand, such as the cocirculation of SARS-CoV-2 and influenza.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.01111-25","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T12:00:15Z","timestamp":1752580815000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the cobas SARS-CoV-2 &amp; Influenza A\/B v2 assay for detecting SARS-CoV-2 and influenza A and B viruses in nasopharyngeal swab specimens"],"prefix":"10.1128","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4119-4628","authenticated-orcid":true,"given":"Eunjung","family":"Jeong","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0330-7828","authenticated-orcid":true,"given":"Minhee","family":"Kang","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyeonseek","family":"Park","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji-Youn","family":"Kim","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Research Institute for Future Medicine, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sun Ae","family":"Yun","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Research Institute for Future Medicine, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Young","family":"Cho","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Research Institute for Future Medicine, Samsung Medical Center","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae-Hoon","family":"Ko","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6405-5305","authenticated-orcid":true,"given":"Tae Yeul","family":"Kim","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8999-7561","authenticated-orcid":true,"given":"Hee Jae","family":"Huh","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine","place":["Gangnam-gu, Republic of Korea"]},{"id":[{"id":"https:\/\/ror.org\/04q78tk20","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University","place":["Gangnam-gu, South Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3688-0145","authenticated-orcid":true,"given":"Nam Yong","family":"Lee","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05a15z872","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine","place":["Gangnam-gu, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32166-8"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41579-020-00461-z"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00549-16"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/irv.12824"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2022.908525"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2023.1295877"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00037-07"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.3109\/10408363.2011.640976"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.3138\/jammi-2022-0039"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00216-020-02958-1"},{"key":"e_1_3_4_12_2","unstructured":"Roche Diagnostics. 2023. Cobas SARS-CoV-2 & influenza A\/B v2. Indianapolis IN USA Roche Diagnostics"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12985-022-01916-w"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics11061084"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2021.36.e328"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.02397-23"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.03125-22"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2017.1275962"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00890-20"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02965-20"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02955-20"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00066-22"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2022.42.4.473"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01111-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01111-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T13:04:29Z","timestamp":1754399069000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.01111-25"}},"subtitle":[],"editor":[{"given":"Kenneth","family":"Gavina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,8,5]]},"references-count":22,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8,5]]}},"alternative-id":["10.1128\/spectrum.01111-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.01111-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,5]]},"assertion":[{"value":"2025-04-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01111-25"}}