MEASUREMENT UNCERTAINTY
The availability of reference method procedures and materials is severely lacking in some disciplines, including my own. However, through meetings such as this, and further research in the field my hopes are high that we will all progress, for once, in the same direction, albeit at different rates… hopefully.
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performance specifications for uncertainty of serum C-reactive protein measurement according to the Milan model 3 (state of the art). Clin Chem Lab Med. 2020; 58 (11): e263–e265.
https://doi.org/10.1515/ cclm-2020-0532.
2 Sandberg S, Fraser CG et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med. 2015 May; 53 (6): 833–5. doi: 10.1515/cclm- 2015-0067. PMID: 25719329.
3 Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest. 1999 Nov; 59 (7): 475–6. doi: 10.1080/00365519950185175. PMID: 10667681.
4 Fraser CG. The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine. Clin Chem Lab Med. 2015 May; 53 (6): 837–40. doi: 10.1515/cclm-2014-0914. PMID: 25720125.
5 Panteghini M. Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med. 2024 Feb 5. doi: 10.1515/cclm- 2023-1325. Epub ahead of print. PMID: 38311825.
6 Sandberg S, Coskun A, Carobene A et al. Analytical performance specifications based on biological variation data – considerations, strengths and limitations. Clin Chem Lab Med. 2024 Mar 20. doi: 10.1515/cclm-2024-0108. Epub ahead of print. PMID: 38501489.
7 Çubukçu HC, Vanstapel F, Thelen M et al. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data. Clin Chem Lab Med. 2023 Nov 17; 62 (4): 597–607. doi: 10.1515/cclm-2023- 0740.
8 Christensen TD. Self-management of oral anticoagulation therapy – methodological and clinical aspects. Dan Med Bull 2011; 58: B4284.
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WWW.PATHOLOGYINPRACTICE.COM APRIL 2024 PIONEERING DIAGNOSTICS 33
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10 Ceriotti F, Fernandez-Calle P, Klee GG et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med. 2017; 55 (2): 189–94. https://doi. org/10.1515/cclm-2016-0091.
11 Panteghini M. Implementation of standardization in clinical practice: not always an easy task. Clin Chem Lab Med. 2012; 50: 1237–41.
12 Pasqualetti S, Chibireva M, Borrillo F, Braga F, Panteghini M. Improving measurement uncertainty of plasma electrolytes: a complex but not impossible task. Clin Chem Lab Med. 2020 Oct 13; 59 (4): e129-e132. doi: 10.1515/cclm-2020- 1399.
13 Oosterhuis WP, Coskun A, Sandberg S, Theodorsson E. Performance specifications for sodium should not be based on biological variation. Clin Chim Acta. 2023 Feb 1; 540: 117221. doi: 10.1016/j. cca.2023.117221.
14 Horvath AR, Bossuyt PM, Sandberg S et al.; Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine. Setting analytical performance specifications based on outcome studies - is it possible? Clin Chem Lab Med. 2015 May; 53 (6): 841–8. doi: 10.1515/cclm-2015-0214.
Dr Stephen MacDonald is Principal Clinical Scientist, The Specialist Haemostasis Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge CB2 0QQ. +44 (0)1223 216746.
ENTER A WORLD OF SIMPLICITY
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