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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 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: cubukcu hc. 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.
Xanthine oxidase enzyme activity in keratoconic corneal epithelium.
Tanriverdi B, Sarac O, Cubukcu HC, Caglayan M, Durak ZE, Durak I, Cagil N. Tanriverdi B, et al. Among authors: cubukcu hc. Int Ophthalmol. 2021 Mar;41(3):1063-1069. doi: 10.1007/s10792-020-01665-1. Epub 2021 Jan 3. Int Ophthalmol. 2021. PMID: 33389422 Clinical Trial.
Utilization of biological variation data in the interpretation of laboratory test results - survey about clinicians' opinion and knowledge.
Emre HO, Karpuzoglu FH, Coskun C, Sezer ED, Ozturk OG, Ucar F, Cubukcu HC, Arslan FD, Deniz L, Senes M, Serteser M, Yazici C, Yucel D, Coskun A. Emre HO, et al. Among authors: cubukcu hc. Biochem Med (Zagreb). 2021 Feb 15;31(1):010705. doi: 10.11613/BM.2021.010705. Epub 2020 Dec 15. Biochem Med (Zagreb). 2021. PMID: 33380892 Free PMC article.
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: cubukcu hc. 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. 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.
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