{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T05:56:33Z","timestamp":1790834193932,"version":"4.1.0"},"reference-count":34,"publisher":"Walter de Gruyter GmbH","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Despite rapid advances in diagnostics, many tests fail to deliver meaningful clinical or system value because their intended use, performance requirements, and implementation context were not clearly articulated early in development. Target product profiles (TPPs) offer a structured, consensus-based framework to define intended use, outline minimal and desirable performance specifications, and set operational expectations for testing technologies. This paper introduces the topic of TPPs, summarising their purpose, structure, and typical development pathways. We describe a three-phase development process of scoping, drafting, and consensus-building, and use real-world examples to illustrate how evidence, stakeholder input, and contextual constraints shape the specification of performance requirements. We highlight how TPPs can support the shift toward outcome-based performance specifications by providing a transparent mechanism to link test analytical and clinical performance with downstream clinical decision-making, patient outcomes, and system-level impact. We also propose strategies to strengthen the methodological robustness and transparency of TPPs and emphasise the essential role laboratory professionals play in ensuring feasibility and clinical relevance of TPP content. When developed collaboratively, including essential laboratory input, TPPs serve as practical tools that guide upstream test research and design and support ongoing verification, validation and life-cycle management, helping to ensure that tests are clinically meaningful, operationally implementable, and responsive to real-world healthcare needs. Ultimately, the integration of well-designed TPPs into test development pipelines has the potential to accelerate innovation that delivers real clinical value and strengthens the role of laboratory medicine in improving patient outcomes.<\/jats:p>","DOI":"10.1515\/cclm-2026-0956","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T04:56:04Z","timestamp":1790830564000},"source":"Crossref","is-referenced-by-count":0,"title":["Target product profiles in laboratory medicine: a framework for defining test requirements and supporting outcome-based performance specifications"],"prefix":"10.1515","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7709-1869","authenticated-orcid":false,"given":"Alison F.","family":"Smith","sequence":"first","affiliation":[{"name":"Leeds Institute of Health Sciences (LIHS), University of Leeds , Leeds , UK"},{"name":"NIHR HealthTech Research Centre in Accelerated Surgical Care, St James\u2019s University Hospital , Leeds , UK"},{"name":"MHRA Centre of Excellence in Regulatory Science and Innovation for In\u00a0Vitro Diagnostics (CERSI-IVD), Sussex Innovation Centre , Brighton , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Cocco","sequence":"additional","affiliation":[{"name":"Leeds Institute of Health Sciences (LIHS), University of Leeds , Leeds , UK"},{"name":"NIHR HealthTech Research Centre in Accelerated Surgical Care, St James\u2019s University Hospital , Leeds , UK"},{"name":"MHRA Centre of Excellence in Regulatory Science and Innovation for In\u00a0Vitro Diagnostics (CERSI-IVD), Sussex Innovation Centre , Brighton , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kile","family":"Green","sequence":"additional","affiliation":[{"name":"NIHR HealthTech Research Centre in Diagnostic and Technology Evaluation , Newcastle upon Tyne , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aisling","family":"Ponzo","sequence":"additional","affiliation":[{"name":"NIHR HealthTech Research Centre in Diagnostic and Technology Evaluation , Newcastle upon Tyne , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerrie A.","family":"Davies","sequence":"additional","affiliation":[{"name":"NIHR HealthTech Research Centre in Accelerated Surgical Care, St James\u2019s University Hospital , Leeds , UK"},{"name":"MHRA Centre of Excellence in Regulatory Science and Innovation for In\u00a0Vitro Diagnostics (CERSI-IVD), Sussex Innovation Centre , Brighton , UK"},{"name":"NIHR Leeds BioMedical Research Centre (BRC), Chapel Allerton Hospital , Leeds , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0137-3218","authenticated-orcid":false,"given":"Katy","family":"Bell","sequence":"additional","affiliation":[{"name":"Sydney School of Public Health, The University of Sydney , Sydney , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bethany","family":"Shinkins","sequence":"additional","affiliation":[{"name":"Warwick Medical School, University of Warwick , Coventry , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariska","family":"Leeflang","sequence":"additional","affiliation":[{"name":"Amsterdam UMC, University of Amsterdam, Epidemiology and Data Science , Amsterdam , The Netherlands"},{"name":"Amsterdam Public Health, Methodology , Amsterdam , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gail","family":"Hayward","sequence":"additional","affiliation":[{"name":"NIHR HealthTech Research Centre in Community Healthcare and University of Oxford, Nuffield Department of Primary Care Health Sciences , Oxford , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Messenger","sequence":"additional","affiliation":[{"name":"Leeds Institute of Health Sciences (LIHS), University of Leeds , Leeds , UK"},{"name":"MHRA Centre of Excellence in Regulatory Science and Innovation for In\u00a0Vitro Diagnostics (CERSI-IVD), Sussex Innovation Centre , Brighton , UK"},{"name":"NIHR HealthTech Research Centre in Community Healthcare and University of Oxford, Nuffield Department of Primary Care Health Sciences , Oxford , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,10,1]]},"reference":[{"key":"2026100104555638637_j_cclm-2026-0956_ref_001","doi-asserted-by":"crossref","unstructured":"Charnaud, SC, Moorthy, V, Reeder, J, Ross, AL. 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