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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: jacobs lhj. 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 end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.
Bank PCD, Jacobs LHJ, van den Berg SAA, van Deutekom HWM, Hamann D, Molenkamp R, Ruivenkamp CAL, Swen JJ, Tops BBJ, Wamelink MMC, Wessels E, Oosterhuis WP. Bank PCD, et al. Among authors: jacobs lhj. Clin Chem Lab Med. 2020 Nov 23:cclm-2020-1384. doi: 10.1515/cclm-2020-1384. Online ahead of print. Clin Chem Lab Med. 2020. PMID: 33554568
Instrument dependent erroneous sodium measurements in hypoproteinemic critically ill patients are causing significant misclassification of dysnatremias.
Tel-Karthaus N, Salet GAM, Jacobs LHJ, Nabbe KCAM, Schoenmakers CHH, van der Doelen RHA, Geerts N, Hoedemakers RMJ. Tel-Karthaus N, et al. Among authors: jacobs lhj. Clin Chem Lab Med. 2019 Aug 27;57(9):e222-e225. doi: 10.1515/cclm-2018-0963. Clin Chem Lab Med. 2019. PMID: 30739096 No abstract available.
18 results