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Marc Thelen

Professor by special appointment 'quality in medical laboratory care'

Radboud University Medical Center

Netherlands

Research Interests

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Professors in Netherlands Professors in Biostatistics Biostatistics professors in Netherlands

About

Professor Marc Thelen holds a special appointment in 'quality in medical laboratory care' at Radboud University Nijmegen Medical Centre, Netherlands. His research focuses on the regulatory landscape of AI-driven medical device software in laboratory medicine, internal quality control practices, and the harmonization of tumor markers. He has published extensively on topics such as external quality assessment programs and the implications of analytical performance specifications in laboratory settings.

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Collaborators (10)

Mario Plebani

University of Padova

ITALY

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Mauro Panteghini

Full Professor

Nicolaus Copernicus University

POLAND

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Volkher Scharnhorst

Department Head / Professor

Eindhoven University of Technology

NETHERLANDS

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Mathie Leers

Professor Data-driven decisionmaking in Healthcare

Open Universiteit

NETHERLANDS

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Katy Bell

Associate Professor of Clinical Epidemiology

University of Sydney

AUSTRALIA

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Andrea Padoan

Assistant Professsor

University of Padova

ITALY

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Evelien Dekker

Professor

Amsterdam University Medical Centers

NETHERLANDS

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Wayne Dimech

University of Melbourne

AUSTRALIA

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Emmanuel J Favaloro

Charles Sturt University - Wagga Wagga Campus

AUSTRALIA

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Etienne Cavalier

Full Professor

University of Liege

BELGIUM

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Marc Thelen

Research Interests

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About

Articles (23)

Garbage in, (mis)diagnosis out: making laboratory measurement bias visible and actionable across clinical algorithm outputs

Harmonization of measurement units: mission impossible or ethical imperative?

The (mis)use of artificial intelligence in laboratory medicine; the good, the bad and the ugly

Does the use of nephelometrically measured albumin enhance the accuracy of adjusted calcium performance in CKD patients?

Model 1b analytical performance specifications – report on the Prague 2025 workshop

A roadmap for standardization of serum albumin measurements

Why Metrological Traceability Matters in Medical Laboratory Diagnostics

Impact of sample size and data origin on the simulation-based analytical performance specification derivation

Evaluating the predictive value of multiple rounds of faecal haemoglobin measurement for the prediction of advanced neoplasia and colorectal cancer: an analysis of data from the Dutch national colorectal cancer screening programme

The Dutch colon cancer screening programme as an example of adopting indirect-outcome-based analytical performance specifications using a virtual analyser concept

Evaluating feasibility of ferritin assay harmonisation with commutable proof-of-concept reference materials and EQA-based monitoring

Validation of synthetic M-protein materials for external quality assessment: homogeneity, commutability, and stability

Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine

IFCC recommendations for internal quality control practice: a missed opportunity

Response to the editorial by Karl Lackner

Comments to the International Council for Standardization in Hematology Guidance for New Lot Verification of Coagulation Reagents, Calibrators, and Controls

External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA

Evaluation of Total Bilirubin in a National Quality Program

Allergy: Evaluation of 16 years (2007–2022) results of the shared external quality assessment program in Belgium, Finland, Portugal and The Netherlands

When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias

EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects

Grupo de Trabajo de la EFLM sobre Acreditación y Normas ISO/CEN sobre cómo abordar los requisitos de la norma ISO15189 sobre retención de documentación y muestras

To rule-in, or not to falsely rule-out, that is the question: evaluation of hs-cTnT EQA performance in light of the ESC-2020 guideline

Collaborators (10)

Mario Plebani

Mauro Panteghini

Volkher Scharnhorst

Mathie Leers

Katy Bell

Andrea Padoan

Evelien Dekker

Wayne Dimech

Emmanuel J Favaloro

Etienne Cavalier

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