Publications by authors named "Solveig Linko"

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Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.
Hikmet Can Çubukçu, Guilaine Boursier, Solveig Linko, Francisco A Bernabeu-Andreu, Pika Meško Brguljan, Neda Milinkovic

Clin Chem Lab Med· September 2025

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EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes.
Solveig Linko, Guilaine Boursier, Francisco A Bernabeu-Andreu, Nana Dzneladze, Florent Vanstapel, Neda Milinkovic

Clin Chem Lab Med· May 2025

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APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.
Hikmet Can Çubukçu, Florent Vanstapel, Marc Thelen, Marith van Schrojenstein Lantman, Francisco A Bernabeu-Andreu, Neda Milinkovic, Solveig Linko

Clin Chem Lab Med· March 2024

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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European -Diagnostics Regulation.
Florent J L A Vanstapel, Matthias Orth, Thomas Streichert, Ettore D Capoluongo, Wytze P Oosterhuis, Solveig Linko

Clin Chem Lab Med· March 2023

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Clinical decision limits as criteria for setting analytical performance specifications for laboratory tests.
Emmi Rotgers, Solveig Linko, Elvar Theodorsson, Timo T Kouri

Clin Chim Acta· February 2023

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An approach for determining allowable between reagent lot variation.
Marith van Schrojenstein Lantman, Hikmet Can Çubukçu, Guilaine Boursier, Mauro Panteghini, Francisco A Bernabeu-Andreu, Neda Milinkovic, Solveig Linko

Clin Chem Lab Med· April 2022

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Improving the laboratory result release process in the light of ISO 15189:2012 standard.
Hikmet Can Çubukçu, Florent Vanstapel, Marc Thelen, Francisco A Bernabeu-Andreu, Marith van Schrojenstein Lantman, Neda Milinkovic, Solveig Linko

Clin Chim Acta· November 2021

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Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation.
Roseri Roelofsen-de Beer, Jos Wielders, Guilaine Boursier, Tatjana Vodnik, Florent Vanstapel, Solveig Linko

Clin Chem Lab Med· February 2020

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Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element.
Marc Thelen, Florent Vanstapel, Pika Meško Brguljan, Bernard Gouget, Guilaine Boursier, Solveig Linko

Clin Chem Lab Med· March 2019

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Analytical performance of the Iris iQ200 automated urine microscopy analyzer.
Solveig Linko, Timo T Kouri, Eila Toivonen, Paivi H Ranta, Eric Chapoulaud

Clin Chim Acta· October 2006

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Evaluation of uncertainty of measurement in routine clinical chemistry--applications to determination of the substance concentration of calcium and glucose in serum.
Solveig Linko, Ulf Ornemark, Rüdiger Kessel, Philip D P Taylor

Clin Chem Lab Med· April 2002

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