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Page 1
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.
Vanstapel FJLA, Orth M, Streichert T, Capoluongo ED, Oosterhuis WP, Çubukçu HC, Bernabeu-Andreu FA, Thelen M, Jacobs LHJ, Linko S, Bhattoa HP, Bossuyt PMM, Meško Brguljan P, Boursier G, Cobbaert CM, Neumaier M. Vanstapel FJLA, et al. Among authors: mesko brguljan p. Clin Chem Lab Med. 2023 Jan 31;61(4):608-626. doi: 10.1515/cclm-2023-0045. Print 2023 Mar 28. Clin Chem Lab Med. 2023. PMID: 36716120 Free article. Review.
Recommendation for the review of biological reference intervals in medical laboratories.
Henny J, Vassault A, Boursier G, Vukasovic I, Mesko Brguljan P, Lohmander M, Ghita I, Andreu FA, Kroupis C, Sprongl L, Thelen MH, Vanstapel FJ, Vodnik T, Huisman W, Vaubourdolle M; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Henny J, et al. Among authors: mesko brguljan p. Clin Chem Lab Med. 2016 Dec 1;54(12):1893-1900. doi: 10.1515/cclm-2016-0793. Clin Chem Lab Med. 2016. PMID: 27748267 Free article. Review.
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.
Roelofsen-de Beer R, Wielders J, Boursier G, Vodnik T, Vanstapel F, Huisman W, Vukasović I, Vaubourdolle M, Sönmez Ç, Linko S, Brugnoni D, Kroupis C, Lohmander M, Šprongl L, Bernabeu-Andreu F, Meško Brguljan P, Thelen M. Roelofsen-de Beer R, et al. Among authors: mesko brguljan p. Clin Chem Lab Med. 2020 Feb 25;58(3):361-367. doi: 10.1515/cclm-2019-1053. Clin Chem Lab Med. 2020. PMID: 31714885 Free article.
Improving the laboratory result release process in the light of ISO 15189:2012 standard.
Can Çubukçu H, Vanstapel F, Thelen M, Bernabeu-Andreu FA, van Schrojenstein Lantman M, Brugnoni D, Mesko Brguljan P, Milinkovic N, Linko S, Vaubourdolle M, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Panteghini M, Boursier G; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. Can Çubukçu H, et al. Among authors: mesko brguljan p. Clin Chim Acta. 2021 Nov;522:167-173. doi: 10.1016/j.cca.2021.08.013. Epub 2021 Aug 18. Clin Chim Acta. 2021. PMID: 34418364
An approach for determining allowable between reagent lot variation.
van Schrojenstein Lantman M, Çubukçu HC, Boursier G, Panteghini M, Bernabeu-Andreu FA, Milinkovic N, Mesko Brguljan P, Linko S, Brugnoni D, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Vanstapel F, Thelen M; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. van Schrojenstein Lantman M, et al. Among authors: mesko brguljan p. Clin Chem Lab Med. 2022 Feb 16;60(5):681-688. doi: 10.1515/cclm-2022-0083. Print 2022 Apr 26. Clin Chem Lab Med. 2022. PMID: 35172415 Free article.
APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.
Çubukçu HC, Vanstapel F, Thelen M, van Schrojenstein Lantman M, Bernabeu-Andreu FA, Meško Brguljan P, Milinkovic N, Linko S, Panteghini M, Boursier G. Çubukçu HC, et al. Among authors: mesko brguljan p. Clin Chem Lab Med. 2023 Nov 17;62(4):597-607. doi: 10.1515/cclm-2023-0740. Print 2024 Mar 25. Clin Chem Lab Med. 2023. PMID: 37978287 Free article.
Estimation of renal function in lung cancer patients.
Trobec K, Knez L, Meško Brguljan P, Cufer T, Lainščak M. Trobec K, et al. Among authors: mesko brguljan p. Lung Cancer. 2012 Jun;76(3):397-402. doi: 10.1016/j.lungcan.2011.11.016. Epub 2011 Dec 15. Lung Cancer. 2012. PMID: 22177534
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.
Meško Brguljan P, Thelen MHM, Bernabeu-Andreu FA, Kroupis C, Boursier G, Vukasović I, Barrett E, Brugnoni D, Lohmander M, Šprongl L, Vodnik T, Ghiţă I, Vanstapel F, Vaubourdolle M, Huisman W. Meško Brguljan P, et al. Adv Lab Med. 2024 Mar 8;5(2):109-114. doi: 10.1515/almed-2024-0020. eCollection 2024 Jun. Adv Lab Med. 2024. PMID: 38939203 Free PMC article. Spanish.
EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects.
Meško Brguljan P, Thelen MHM, Bernabeu-Andreu FA, Kroupis C, Boursier G, Vukasović I, Barrett E, Brugnoni D, Lohmander M, Šprongl L, Vodnik T, Ghiţă I, Vanstapel F, Vaubourdolle M, Huisman W. Meško Brguljan P, et al. Adv Lab Med. 2024 Jan 30;5(2):103-108. doi: 10.1515/almed-2023-0053. eCollection 2024 Jun. Adv Lab Med. 2024. PMID: 38939196 Free PMC article.