{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T21:44:31Z","timestamp":1789767871728,"version":"4.0.1"},"reference-count":30,"publisher":"American Society for Microbiology","issue":"3","license":[{"start":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"SD Biosensor"},{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"publisher","award":["RS-2025-02232997"],"award-info":[{"award-number":["RS-2025-02232997"]}],"id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"crossref","award":["RS-2024-00332244"],"award-info":[{"award-number":["RS-2024-00332244"]}],"id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,3,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      The STANDARD M10 Flu\/RSV\/SARS-CoV-2 Fast assay (M10 Fast), recently CE-marked, is an updated version of the STANDARD M10 Flu\/RSV\/SARS-CoV-2 assay. It includes additional gene targets to improve sensitivity and coverage and reduces run time from 60\u202fmin to 36\u202fmin. This study evaluated the analytical and clinical performance of the M10 Fast assay. A total of 664 nasopharyngeal swab specimens (108 influenza A-positive, 119 influenza B-positive, 79 respiratory syncytial virus [RSV]-positive, 165 SARS-CoV-2-positive, 2 influenza A\/RSV co-positive, 1 RSV\/SARS-CoV-2 co-positive, and 190 negative), confirmed by the BIOFIRE Respiratory Panel 2.1\n                      <jats:italic toggle=\"yes\">plus<\/jats:italic>\n                      (RP2.1\n                      <jats:italic toggle=\"yes\">plus<\/jats:italic>\n                      ), were tested in parallel using the M10 Fast assay and the Allplex SARS-CoV-2\/FluA\/FluB\/RSV assay (Allplex). RNA standards were serially diluted and tested with the M10 Fast assay to determine the limit of detection (LOD). Using RP2.1\n                      <jats:italic toggle=\"yes\">plus<\/jats:italic>\n                      as the reference standard, the M10 Fast assay demonstrated sensitivities of 98.2%, 100%, 95.1%, and 100% for influenza A, influenza B, RSV, and SARS-CoV-2, respectively. The Allplex assay showed sensitivities of 88.2%, 100%, 91.5%, and 100% for the same viruses. Both assays exhibited high specificity (&gt;99%). The LODs of the M10 Fast assay were 7.8, 35.3, 532.7, 34.7, and 88.0 copies\/mL for influenza A, influenza B, RSV, and SARS-CoV-2 ORF1ab\/E and N genes, respectively, and were lower than previously reported Allplex LODs, except for RSV. The M10 Fast assay reliably detects influenza A and B, RSV, and SARS-CoV-2 with high sensitivity and specificity, demonstrating performance comparable to or exceeding that of the widely used Allplex assay.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>The STANDARD M10 Flu\/RSV\/SARS-CoV-2 Fast assay (M10 Fast) is an updated version of the STANDARD M10 Flu\/RSV\/SARS-CoV-2 assay. This study demonstrates that the M10 Fast assay reliably detects influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2 with high sensitivity and specificity, including improved detection at low viral loads. Its enhanced performance and shorter turnaround time support timely clinical decision-making and strengthen public health responses, particularly during periods of cocirculation of influenza, RSV, and SARS-CoV-2.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.02672-25","type":"journal-article","created":{"date-parts":[[2026,1,26]],"date-time":"2026-01-26T14:01:11Z","timestamp":1769436071000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the STANDARD M10 Flu\/RSV\/SARS-CoV-2 Fast assay for the detection of influenza A\/B viruses, respiratory syncytial virus, and SARS-CoV-2 in nasopharyngeal swab specimens"],"prefix":"10.1128","volume":"14","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":["Seoul, 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":["Seoul, 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":["Seoul, 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":["Seoul, 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":["Seoul, 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":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2020.05.008"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.14661"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.micinf.2020.05.016"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31052-7"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid2606.200299"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/Spectrum.00831-21"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00037-07"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104538"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02965-20"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02955-20"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.27111"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00066-22"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2023.43.1.111"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2023.105402"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2024.105674"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2025.105827"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2021.36.e328"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjid.2023.103702"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29855"},{"key":"e_1_3_5_21_2","doi-asserted-by":"publisher","DOI":"10.5365\/wpsar.2018.9.3.003"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.05.025"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1586\/14737159.2016.1134325"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2024.2353690"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2020.113925"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2022.42.4.473"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00549-16"},{"key":"e_1_3_5_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(17)30120-0"},{"key":"e_1_3_5_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2021.114304"},{"key":"e_1_3_5_30_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0278530"},{"key":"e_1_3_5_31_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.01111-25"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02672-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02672-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T14:06:08Z","timestamp":1772546768000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.02672-25"}},"subtitle":[],"editor":[{"given":"J\u00e9r\u00f4me","family":"Le Goff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,3,3]]},"references-count":30,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3,3]]}},"alternative-id":["10.1128\/spectrum.02672-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.02672-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,3]]},"assertion":[{"value":"2025-08-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e02672-25"}}