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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: bossuyt pmm. 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.
Setting analytical performance specifications based on outcome studies - is it possible?
Horvath AR, Bossuyt PM, Sandberg S, John AS, Monaghan PJ, Verhagen-Kamerbeek WD, Lennartz L, Cobbaert CM, Ebert C, Lord SJ; Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine. Horvath AR, et al. Clin Chem Lab Med. 2015 May;53(6):841-8. doi: 10.1515/cclm-2015-0214. Clin Chem Lab Med. 2015. PMID: 25996384 Free article. Review.
From biomarkers to medical tests: the changing landscape of test evaluation.
Horvath AR, Lord SJ, StJohn A, Sandberg S, Cobbaert CM, Lorenz S, Monaghan PJ, Verhagen-Kamerbeek WD, Ebert C, Bossuyt PM; Test Evaluation Working Group of the European Federation of Clinical Chemistry Laboratory Medicine. Horvath AR, et al. Clin Chim Acta. 2014 Jan 1;427:49-57. doi: 10.1016/j.cca.2013.09.018. Epub 2013 Sep 27. Clin Chim Acta. 2014. PMID: 24076255
Biomarker development targeting unmet clinical needs.
Monaghan PJ, Lord SJ, St John A, Sandberg S, Cobbaert CM, Lennartz L, Verhagen-Kamerbeek WD, Ebert C, Bossuyt PM, Horvath AR; Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine. Monaghan PJ, et al. Clin Chim Acta. 2016 Sep 1;460:211-9. doi: 10.1016/j.cca.2016.06.037. Epub 2016 Jun 30. Clin Chim Acta. 2016. PMID: 27374304
Practical guide for identifying unmet clinical needs for biomarkers.
Monaghan PJ, Robinson S, Rajdl D, Bossuyt PMM, Sandberg S, St John A, O'Kane M, Lennartz L, Röddiger R, Lord SJ, Cobbaert CM, Horvath AR. Monaghan PJ, et al. Among authors: bossuyt pmm. EJIFCC. 2018 Jul 11;29(2):129-137. eCollection 2018 Jul. EJIFCC. 2018. PMID: 30050396 Free PMC article.
438 results