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Editorial
. 2025 Feb 18;63(8):1455-1457.
doi: 10.1515/cclm-2025-0121. Print 2025 Jul 28.

Setting analytical performance specification by simulation (Milan model 1b)

Hui Qi Low  1 , Andrea Rita Horvath  2 , Tze Ping Loh  3 , Mario Plebani  4 , Chun Yee Lim  1
Affiliations
Free article
Editorial

Setting analytical performance specification by simulation (Milan model 1b)

Hui Qi Low et al. Clin Chem Lab Med. .
Free article
No abstract available

Keywords: analytical performance specification; biological variation; clinical chemistry; external quality assurance; method evaluation; quality control.

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References

    1. Sandberg, S, Fraser, CG, Horvath, AR, Jansen, R, Jones, G, Oosterhuis, W, 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;53:833–5. https://doi.org/10.1515/cclm-2015-0067 . - DOI
    1. Çubukçu, HC, Vanstapel, F, Thelen, M, van Schrojenstein Lantman, M, Bernabeu-Andreu, FA, Meško Brguljan, P, 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;62:597–607. https://doi.org/10.1515/cclm-2023-0740 . - DOI
    1. Loh, TP, Markus, C, Lim, CY. Impact of analytical imprecision and bias on patient classification. Am J Clin Pathol 2024;161:4–8. https://doi.org/10.1093/ajcp/aqad115 . - DOI
    1. Horvath, AR, Bell, KJL, Ceriotti, F, Jones, GR, Loh, TP, Lord, S, et al.. Outcome-based analytical performance specifications: current status and future challenges. Clin Chem Lab Med 2024;62:1474–82. https://doi.org/10.1515/cclm-2024-0125 . - DOI
    1. Jones, GRD, Bell, KJL, Ceriotti, F, Loh, TP, Lord, S, Sandberg, S, et al.. Applying the Milan models to setting analytical performance specifications - considering all the information. Clin Chem Lab Med 2024;62:1531–7. https://doi.org/10.1515/cclm-2024-0104 . - DOI

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