{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T14:36:33Z","timestamp":1793111793247,"version":"4.5.0"},"reference-count":34,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["clinicalkey.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Microbiological Methods"],"published-print":{"date-parts":[[2026,11]]},"DOI":"10.1016\/j.mimet.2026.107738","type":"journal-article","created":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T22:29:42Z","timestamp":1791066582000},"page":"107738","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["The regulatory landscape for clinical metagenomics-based diagnostics in Europe: a critical review"],"prefix":"10.1016","volume":"250","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8800-6380","authenticated-orcid":false,"given":"Tarek","family":"Badr","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khaled","family":"Hatem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.mimet.2026.107738_bb0005","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1038\/s41576-019-0113-7","article-title":"Clinical metagenomics","volume":"20","author":"Chiu","year":"2019","journal-title":"Nat. Rev. Genet."},{"key":"10.1016\/j.mimet.2026.107738_bb0010","doi-asserted-by":"crossref","first-page":"761","DOI":"10.1001\/jamaneurol.2025.0461","article-title":"The regulatory landscape for clinical metagenomic testing","volume":"82","author":"Chiu","year":"2025","journal-title":"JAMA Neurol."},{"key":"10.1016\/j.mimet.2026.107738_bb0015","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2021.104812","article-title":"Recommendations for the introduction of metagenomic next-generation sequencing in clinical virology, part II: bioinformatic analysis and reporting","volume":"138","author":"de Vries","year":"2021","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.mimet.2026.107738_bb0020","series-title":"Directive 98\/79\/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices","volume":"vol. 331","author":"Directive 98\/79\/EC","year":"1998"},{"key":"10.1016\/j.mimet.2026.107738_bb0025","author":"QCMD"},{"key":"10.1016\/j.mimet.2026.107738_bb0030","author":"European Commission","year":"2025"},{"key":"10.1016\/j.mimet.2026.107738_bb0035","author":"European Commission"},{"key":"10.1016\/j.mimet.2026.107738_bb0040","author":"European Commission"},{"key":"10.1016\/j.mimet.2026.107738_bb0045","author":"European Union"},{"key":"10.1016\/j.mimet.2026.107738_bb0050","author":"European Union"},{"key":"10.1016\/j.mimet.2026.107738_bb0055","doi-asserted-by":"crossref","DOI":"10.3390\/cells10113226","article-title":"Next- and third-generation sequencing outperforms culture-based methods in the diagnosis of ascitic fluid bacterial infections of ICU patients","volume":"10","author":"Goelz","year":"2021","journal-title":"Cells"},{"key":"10.1016\/j.mimet.2026.107738_bb0060","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.02916-20","article-title":"Metagenomic sequencing as a pathogen-agnostic clinical diagnostic tool for infectious diseases: a systematic review and meta-analysis of diagnostic test accuracy studies","volume":"59","author":"Govender","year":"2021","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.mimet.2026.107738_bb0065","doi-asserted-by":"crossref","DOI":"10.3390\/microorganisms12122482","article-title":"Unlocking the potential of metagenomics with the PacBio high-fidelity sequencing technology","volume":"12","author":"Han","year":"2024","journal-title":"Microorganisms"},{"key":"10.1016\/j.mimet.2026.107738_bb0070","article-title":"Advisory opinion of the AWMF ad hoc commission in-vitro diagnostic medical devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017\/746 (IVDR)","volume":"19","author":"Hoffm\u00fcller","year":"2021","journal-title":"Ger. Med. Sci."},{"key":"10.1016\/j.mimet.2026.107738_bb0075","unstructured":"ISO 15189:2022. ISO 2026 https:\/\/www.iso.org\/standard\/76677.html (accessed September 26, 2026)."},{"key":"10.1016\/j.mimet.2026.107738_bb0080","author":"ISO\/TS 22692:2020"},{"key":"10.1016\/j.mimet.2026.107738_bb0085","doi-asserted-by":"crossref","DOI":"10.3390\/genes10090655","article-title":"Viral metagenomics in the clinical realm: lessons learned from a Swiss-wide ring trial","volume":"10","author":"Junier","year":"2019","journal-title":"Genes"},{"key":"10.1016\/j.mimet.2026.107738_bb0090","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2020.104691","article-title":"Recommendations for the introduction of metagenomic high-throughput sequencing in clinical virology, part I: wet lab procedure","volume":"134","author":"L\u00f3pez-Labrador","year":"2021","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.mimet.2026.107738_bb0095","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2024.105695","article-title":"Multicenter benchmarking of short and long read wet lab protocols for clinical viral metagenomics","volume":"173","author":"Lopez-Labrador","year":"2024","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.mimet.2026.107738_bb0100","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1093\/clinchem\/hvab173","article-title":"The role of metagenomics and next-generation sequencing in infectious disease diagnosis","volume":"68","author":"Miller","year":"2022","journal-title":"Clin. Chem."},{"key":"10.1016\/j.mimet.2026.107738_bb0105","doi-asserted-by":"crossref","DOI":"10.3389\/fcimb.2024.1441805","article-title":"Enhancing ascitic fungal infection diagnosis through next-generation sequencing: a pilot study in surgical ICU patients","volume":"14","author":"Posadas-Cantera","year":"2024","journal-title":"Front. Cell. Infect. Microbiol."},{"key":"10.1016\/j.mimet.2026.107738_bb0110","author":"Joint Research Centre"},{"key":"10.1016\/j.mimet.2026.107738_bb0115","series-title":"Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in Vitro Diagnostic Medical Devices and Repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU (Text with EEA Relevance)","volume":"vol. 117","author":"Regulation (EU) 2017\/746","year":"2017"},{"key":"10.1016\/j.mimet.2026.107738_bb0120","volume":"vol. 019","author":"Regulation (EU) 2022\/112","year":"2022"},{"key":"10.1016\/j.mimet.2026.107738_bb0125","author":"Regulation (EU) 2024\/1860","year":"2024"},{"key":"10.1016\/j.mimet.2026.107738_bb0130","author":"Bundes\u00e4rztekammer"},{"key":"10.1016\/j.mimet.2026.107738_bb0135","doi-asserted-by":"crossref","first-page":"776","DOI":"10.5858\/arpa.2016-0539-RA","article-title":"Validation of metagenomic next-generation sequencing tests for universal pathogen detection","volume":"141","author":"Schlaberg","year":"2017","journal-title":"Arch. Pathol. Lab Med."},{"key":"10.1016\/j.mimet.2026.107738_bb0140","doi-asserted-by":"crossref","first-page":"9016","DOI":"10.1038\/s41467-024-51470-y","article-title":"Laboratory validation of a clinical metagenomic next-generation sequencing assay for respiratory virus detection and discovery","volume":"15","author":"Tan","year":"2024","journal-title":"Nat. Commun."},{"key":"10.1016\/j.mimet.2026.107738_bb0145","series-title":"The Impact of the New European IVD-Classification Rules on the Notified Body Involvement","author":"Van Drongelen","year":"2018"},{"key":"10.1016\/j.mimet.2026.107738_bb0150","doi-asserted-by":"crossref","first-page":"864","DOI":"10.1038\/s41597-024-03672-8","article-title":"Benchmarking bacterial taxonomic classification using nanopore metagenomics data of several mock communities","volume":"11","author":"Van Uffelen","year":"2024","journal-title":"Sci. Data"},{"key":"10.1016\/j.mimet.2026.107738_bb0155","doi-asserted-by":"crossref","DOI":"10.1056\/NEJMoa1803396","article-title":"Clinical metagenomic sequencing for diagnosis of meningitis and encephalitis","author":"Wilson","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.mimet.2026.107738_bb0160","doi-asserted-by":"crossref","first-page":"1261","DOI":"10.1016\/j.cmi.2024.06.028","article-title":"How to verify and validate a clinical microbiology test before it can be used in routine diagnostics: a practical guide","volume":"30","author":"Yusuf","year":"2024","journal-title":"Clin. Microbiol. Infect."},{"key":"10.1016\/j.mimet.2026.107738_bb0165","doi-asserted-by":"crossref","DOI":"10.3389\/fcimb.2024.1458316","article-title":"Application of metagenomic next-generation sequencing in the diagnosis of infectious diseases","volume":"14","author":"Zhao","year":"2024","journal-title":"Front. Cell. Infect. Microbiol."},{"key":"10.1016\/j.mimet.2026.107738_bb0170","doi-asserted-by":"crossref","DOI":"10.1002\/mco2.316","article-title":"Nanopore sequencing technology and its applications","volume":"4","author":"Zheng","year":"2023","journal-title":"MedComm"}],"container-title":["Journal of Microbiological Methods"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0167701226003507?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0167701226003507?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T14:02:03Z","timestamp":1793109723000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0167701226003507"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,11]]},"references-count":34,"alternative-id":["S0167701226003507"],"URL":"https:\/\/doi.org\/10.1016\/j.mimet.2026.107738","relation":{},"ISSN":["0167-7012"],"issn-type":[{"value":"0167-7012","type":"print"}],"subject":[],"published":{"date-parts":[[2026,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"The regulatory landscape for clinical metagenomics-based diagnostics in Europe: a critical review","name":"articletitle","label":"Article Title"},{"value":"Journal of Microbiological Methods","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.mimet.2026.107738","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"107738"}}