{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T08:13:54Z","timestamp":1789460034390,"version":"build-2803163510"},"reference-count":51,"publisher":"Walter de Gruyter GmbH","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The main purpose of establishing APS is to ensure that test performance aligns with their specific clinical goals. Analytical performance specifications serve multiple functions: as acceptance criteria to verify that\n                    <jats:italic>in\u00a0vitro<\/jats:italic>\n                    diagnostic medical devices (IVD MD) meet regulatory and quality standards before market release; for external quality assurance assessments; for quality control, monitoring reagent lot-to-lot variability, and allowing preanalytical variation assessments in labs; and for guiding purchasing decisions by healthcare providers, reimbursement agencies, and both public and private insurers. Over the years, various systems and projects have been established to evaluate the current state of the art (Model 3) of IVD MD through external quality assurance (EQA). Different national and international EQA providers often use distinct acceptance criteria tailored to their organisational goals and local healthcare settings. Model 2, which relies on biological variation data, has been effectively supported by the European Federation of Clinical Chemistry and Laboratory Medicine\u2019s database and its interactive tools for calculating APS (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.biologicalvariation.eu\">www.biologicalvariation.eu<\/jats:ext-link>\n                    ). Nonetheless, debates continue about optimal APS setting methods and the most suitable models for different measurands and scenarios. To explore these issues further, workshops were held in Prague in 2023 and 2025. This report presents the expert presentations from the 2025 workshop, which exclusively focused on APS based on Model\u00a01b.\n                  <\/jats:p>","DOI":"10.1515\/cclm-2026-1024","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T06:56:11Z","timestamp":1786949771000},"source":"Crossref","is-referenced-by-count":0,"title":["Model 1b analytical performance specifications\u00a0\u2013\u00a0report on the Prague 2025 workshop"],"prefix":"10.1515","author":[{"given":"Andrea R.","family":"Horvath","sequence":"first","affiliation":[{"name":"Department of Chemical Pathology , New South Wales Health Pathology, Prince of Wales Hospital, Level 4 Campus Centre , Randwick, Sydney , NSW , Australia"},{"name":"School of Public Health , University of Sydney , Sydney , Australia"},{"name":"Faculty of Medicine , University of New South Wales , Sydney , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sverre","family":"Sandberg","sequence":"additional","affiliation":[{"name":"Norwegian Organization for Quality Improvement of Laboratory Examinations (NOKLUS) , Haraldsplass Deaconess Hospital , Bergen , Norway"},{"name":"Norwegian Porphyria Centre, Department of Medical Biochemistry and Pharmacology , Haukeland University Hospital , Bergen , Norway"},{"name":"Institute of Public Health and Primary Health Care, University of Bergen , Bergen , Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1771-669X","authenticated-orcid":false,"given":"Marc H.M.","family":"Thelen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Radboud University Medical Center , Nijmegen , The Netherlands"},{"name":"Foundation for Quality Assurance in Medical Laboratory Diagnostics (SKML) , Nijmegen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7147-3433","authenticated-orcid":false,"given":"Mauro","family":"Panteghini","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University , Bydgoszcz, Torun , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5321-9354","authenticated-orcid":false,"given":"Hikmet Can","family":"\u00c7ubuk\u00e7u","sequence":"additional","affiliation":[{"name":"Department of Medical Biochemistry , Ministry of Health Sincan Training and Research Hospital , Ankara , T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmi","family":"Rotgers","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry , University of Helsinki, and HUSLAB, HUS Diagnostic Center, Helsinki University Hospital , Helsinki , Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Kilpatrick","sequence":"additional","affiliation":[{"name":"Manchester University NHS Foundation Trust , Manchester , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0137-3218","authenticated-orcid":false,"given":"Katy J.L.","family":"Bell","sequence":"additional","affiliation":[{"name":"Sydney School of Public Health , Faculty of Medicine and Health, The University of Sydney , Sydney , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham R.D.","family":"Jones","sequence":"additional","affiliation":[{"name":"Faculty of Medicine , University of New South Wales , Sydney , Australia"},{"name":"Department of Chemical Pathology , SydPath, St Vincent\u2019s Hospital , Darlinghurst , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvar","family":"Theodorsson","sequence":"additional","affiliation":[{"name":"Department of Biomedical and Clinical Sciences , Link\u00f6ping University , Link\u00f6ping , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"2026091507553297559_j_cclm-2026-1024_ref_001","doi-asserted-by":"crossref","unstructured":"Kenny, D, Fraser, CG, Petersen, PH, Kallner, A. 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