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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: orth m. 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.
The use of error and uncertainty methods in the medical laboratory.
Oosterhuis WP, Bayat H, Armbruster D, Coskun A, Freeman KP, Kallner A, Koch D, Mackenzie F, Migliarino G, Orth M, Sandberg S, Sylte MS, Westgard S, Theodorsson E. Oosterhuis WP, et al. Among authors: orth m. Clin Chem Lab Med. 2018 Jan 26;56(2):209-219. doi: 10.1515/cclm-2017-0341. Clin Chem Lab Med. 2018. PMID: 28796637 Free article.
Opinion: redefining the role of the physician in laboratory medicine in the context of emerging technologies, personalised medicine and patient autonomy ('4P medicine').
Orth M, Averina M, Chatzipanagiotou S, Faure G, Haushofer A, Kusec V, Machado A, Misbah SA, Oosterhuis W, Pulkki K, Twomey PJ, Wieland E. Orth M, et al. J Clin Pathol. 2019 Mar;72(3):191-197. doi: 10.1136/jclinpath-2017-204734. Epub 2017 Dec 22. J Clin Pathol. 2019. PMID: 29273576 Free PMC article.
498 results