{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T14:00:06Z","timestamp":1775570406170,"version":"3.50.1"},"reference-count":36,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T00:00:00Z","timestamp":1775520000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T00:00:00Z","timestamp":1775520000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Abbott | Abbott Germany"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,4,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      After transition to the endemic phase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, multiplex molecular assays detecting SARS-CoV-2, influenza A (FluA) and B (FluB), and respiratory syncytial virus (RSV) are key to following international monitoring guidance, especially in future outbreak situations. In the present study, the analytical and clinical performance of the Alinity m Resp-4-Plex assay (\u201cAlin4Plex\u201d) was evaluated in comparison to those of three other assays: Alinity m SARS-CoV-2 (\u201cAlinSARS\u201d), RealTi\n                      <jats:italic toggle=\"yes\">m<\/jats:italic>\n                      e SARS-CoV-2 (\u201cRT-SARS\u201d), and Allplex SARS-CoV-2\/FluA\/FluB\/RSV (\u201cAllplex\u201d). Alin4Plex and AlinSARS exhibited 100% detection rates at 100 IU\/mL, while RT-SARS and Allplex showed 90 and 40% at 200 IU\/mL, respectively. Similarly, 100% detection rates by Alin4Plex were obtained at 100 (FluA, FluB) and 500 cp\/mL (RSV) and by Allplex at 5,000 (FluB) and 10,000 cp\/mL (RSV), with a 90% detection rate at 10,000 cp\/mL (FluA). Retesting clinical specimens with 201, 198, 73, and 188 positive results for SARS-CoV-2, FluA, FluB, and RSV using Alin4Plex, the positivity rate by Allplex was considerably lower, with 119 (59%), 154 (78%), 42 (58%), and 91 positive specimens (48%), respectively, and decreased with increasing Ct values. Ct values correlated well between Alin4Plex and Allplex for SARS-CoV-2 and RSV (\n                      <jats:italic toggle=\"yes\">r<\/jats:italic>\n                      &gt; 0.92), but correlation was only moderate for FluA and FluB (\n                      <jats:italic toggle=\"yes\">r<\/jats:italic>\n                      = 0.56 and 0.40, respectively). Overall, the multiplex assay Alin4Plex conducted on the high-throughput, random access Alinity m system exhibited high sensitivity for SARS-CoV-2, FluA, FluB, and RSV in a single test. It enables laboratories to rapidly scale up respiratory testing in future outbreak situations and provides valuable information for optimized patient management.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>After the transition of the coronavirus disease 2019 (COVID-19) pandemic into an endemic phase, a rebound of transmissions of influenza A, influenza B, and respiratory syncytial virus (RSV) with the risk of severe morbidity and mortality has been observed. Overlapping symptoms complicate accurate diagnosis of respiratory infections and may delay adequate treatment. A multiplex PCR assay conducted on a random-access high-throughput automated platform enables accelerated and simultaneous detection of respiratory viruses, thus enhancing diagnostic efficiency, reducing the need for multiple tests, consolidating workflow, and enabling timely and appropriate patient care. This study evaluated the analytical and clinical performance of the Alinity m Resp-4-Plex assay for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and RSV in comparison to other commercially available multiplex and singleplex tests. Results are crucial for identifying the most appropriate diagnostic method to improve patient outcome and optimize resource utilization in clinical settings.<\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.00306-25","type":"journal-article","created":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T13:00:30Z","timestamp":1773147630000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and clinical evaluation of the Alinity m Resp-4-Plex assay in comparison to two singleplex SARS-CoV-2 assays and one multiplex respiratory assay"],"prefix":"10.1128","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6960-0141","authenticated-orcid":true,"given":"Robert","family":"Ehret","sequence":"first","affiliation":[{"name":"Medical Center for Infectious Diseases Berlin","place":["Berlin, Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malik","family":"Prentice","sequence":"additional","affiliation":[{"name":"Medical Center for Infectious Diseases Berlin","place":["Berlin, Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7045-1105","authenticated-orcid":false,"given":"Birgit","family":"Reinhardt","sequence":"additional","affiliation":[{"name":"Abbott GmbH","place":["Wiesbaden, Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2511-9553","authenticated-orcid":true,"given":"Martin","family":"Obermeier","sequence":"additional","affiliation":[{"name":"Medical Center for Infectious Diseases Berlin","place":["Berlin, Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.2013182117"},{"key":"e_1_3_4_3_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2023. Influenza in Europe. Data from EU\/EEA countries 2019-2023 seasons. Available from: https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/images\/influenza-seasons-summary-2019-2023.png. Retrieved 15 Nov 2024."},{"key":"e_1_3_4_4_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2022. Intensified circulation of respiratory syncytial virus (RSV) and associated hospital burden in the EU\/EEA. Available from: https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/RRA-20221128-473.pdf. Retrieved 15 Nov 2024."},{"key":"e_1_3_4_5_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2024. Overview of respiratory virus epidemiology in the EU\/EEA. Available from: https:\/\/erviss.org. Retrieved 15 Nov 2024."},{"key":"e_1_3_4_6_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2024. Respiratory syncytial virus (RSV). Available from: https:\/\/www.ecdc.europa.eu\/en\/respiratory-syncytial-virus-rsv. Retrieved 15 Nov 2024."},{"key":"e_1_3_4_7_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2024. Factsheet about seasonal influenza. Available from: https:\/\/www.ecdc.europa.eu\/en\/seasonal-influenza\/facts\/factsheet. Retrieved 15 Nov 2024."},{"key":"e_1_3_4_8_2","unstructured":"European Centre for Disease Prevention and Control (ECDC). 2022. Joint EC WHO and ECDC statement: influenza season epidemic kicks off early in Europe as concerns over RSV rise and COVID-19 is still a threat. Available from: https:\/\/www.ecdc.europa.eu\/en\/news-events\/joint-ec-who-and-ecdc-statement-influenza-season-epidemic-kicks-early-europe-concerns. Retrieved 28 Nov 2024."},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.01090-21"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12931-024-02862-7"},{"key":"e_1_3_4_11_2","unstructured":"European Centre for Disease Prevention and Control. 2020. Operational considerations for influenza surveillance in the WHO European region during COVID-19: interim guidance. Available from: https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/Joint-influenza-interim-guidance.pdf. Retrieved 14 Apr 2021."},{"key":"e_1_3_4_12_2","unstructured":"Abbott Molecular Inc. 2022. Alinity m Resp-4-Plex Amp Kit [package insert; 53-608209]"},{"key":"e_1_3_4_13_2","unstructured":"Abbott Molecular Inc. 2022. Alinity m SARS-CoV-2 Amp Kit [package insert; 53-608278]"},{"key":"e_1_3_4_14_2","unstructured":"Abbott Molecular Inc. 2020. Abbott RealTime SARS-CoV-2 Amp Kit [package insert; 51-608442]"},{"key":"e_1_3_4_15_2","unstructured":"Seegene Inc. 2020. Allplex SARS-CoV-2\/FluA\/FluB\/RSV Assay [package insert]. V0.1 RUO"},{"key":"e_1_3_4_16_2","volume-title":"NIBSC code: 20\/146. Instructions for use (V 3.0)","author":"National Institute for Biological Standards and Control (NIBSC)","year":"2021","unstructured":"National Institute for Biological Standards and Control (NIBSC). 2021. First WHO international standard for SARS-CoV-2 RNA. In NIBSC code: 20\/146. Instructions for use (V 3.0)"},{"key":"e_1_3_4_17_2","volume-title":"WHO\/BS\/2020","author":"Bentley E","year":"2020","unstructured":"Bentley E, Mee ET, Routley S, Mate R, Fritzsche M, Hurley M, Duff YL, Anderson R, Hockley J, Rigsby P, Page M, Rose N, MattiuzzoG, The Collaborative Study Group. 2020. Collaborative study for the establishment of a WHO international standard for SARS-CoV-2 RNA. In WHO\/BS\/2020. WHO Expert Committee on Biological Standardization."},{"key":"e_1_3_4_18_2","volume-title":"EP17-A2. Evaluation of detection capability for clinical laboratory measurement procedures. Approved guideline","author":"Clinical and Laboratory Standards Institute","year":"2012","unstructured":"Clinical and Laboratory Standards Institute. 2012. EP17-A2. Evaluation of detection capability for clinical laboratory measurement procedures. Approved guideline. 2nd ed. Vol. 32. Clinical and Laboratory Standards Institute, Wayne, PA, USA.","edition":"2"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2021.114338"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2023.e22112"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1093\/jalm\/jfaa187"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104578"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01535-20"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03119-20"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2021.114102"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104474"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104869"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2021.36.e328"},{"key":"e_1_3_4_29_2","unstructured":"Ehret R Solecki M Schmid D Obermeier M. 2024. Evaluation of the performance of the Hologic Panther fusion 4 plex-assay abstr Poster P0170 at ECCMID 2024 Barcelona Spain 27 Apr 2024"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-023-04703-9"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.24242"},{"key":"e_1_3_4_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2021.115575"},{"key":"e_1_3_4_33_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2022.105164"},{"key":"e_1_3_4_34_2","doi-asserted-by":"publisher","DOI":"10.1684\/abc.2022.1771"},{"key":"e_1_3_4_35_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0262656"},{"key":"e_1_3_4_36_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa1199"},{"key":"e_1_3_4_37_2","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1177\/00333549101250S305","article-title":"Influenza: the once and future pandemic","volume":"125","author":"Taubenberger JK","year":"2010","unstructured":"Taubenberger JK, Morens DM. 2010. Influenza: the once and future pandemic. Public Health Rep 125 Suppl 3:16\u201326.","journal-title":"Public Health Rep"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00306-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00306-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T13:10:43Z","timestamp":1775567443000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.00306-25"}},"subtitle":[],"editor":[{"given":"Alexander","family":"Bello","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2026,4,7]]},"references-count":36,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4,7]]}},"alternative-id":["10.1128\/spectrum.00306-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.00306-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,7]]},"assertion":[{"value":"2025-01-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00306-25"}}