Applying the Milan models to setting analytical performance specifications – considering all the information

Author:

Jones Graham R.D.12,Bell Katy J.L.3,Ceriotti Ferruccio4ORCID,Loh Tze Ping5,Lord Sally67,Sandberg Sverre8910,Smith Alison F.1112ORCID,Horvath Andrea Rita2313

Affiliation:

1. Department of Chemical Pathology, SydPath , St Vincent’s Hospital , Darlinghurst , NSW , Australia

2. Faculty of Medicine , University of NSW , Kensington , NSW , Australia

3. School of Public Health , The University of Sydney , C amperdown , NSW , Australia

4. Clinical Laboratory , Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico , Milano , Italy

5. Department of Laboratory Medicine , National University Hospital , Singapore , Singapore

6. School of Medicine , University of Notre Dame , Darlinghurst , NSW , Australia

7. NHMRC Clinical Trials Centre , The University of Sydney , Camperdown , NSW , Australia

8. Norwegian Organization for Quality Improvement of Laboratory Examinations (NOKLUS), Haraldsplass Deaconess Hospital , Bergen , Norway

9. Norwegian Porphyria Centre, Department of Medical Biochemistry and Pharmacology , Haukeland University Hospital , Bergen , Norway

10. Institute of Public Health and Primary Health Care , University of Bergen , Bergen , Norway

11. Test Evaluation Group, Academic Unit of Health Economics , University of Leeds , Leeds , UK

12. NIHR Leeds In Vitro Diagnostic (IVD) Co-Operative , Leeds , UK

13. Department of Chemical Pathology , New South Wales Health Pathology, Prince of Wales Hospital , Randwick , Australia

Abstract

Abstract Analytical performance specifications (APS) are used for decisions about the required analytical quality of pathology tests to meet clinical needs. The Milan models, based on clinical outcome, biological variation, or state of the art, were developed to provide a framework for setting APS. An approach has been proposed to assign each measurand to one of the models based on a defined clinical use, physiological control, or an absence of quality information about these factors. In this paper we propose that in addition to such assignment, available information from all models should be considered using a risk-based approach that considers the purpose and role of the actual test in a clinical pathway and its impact on medical decisions and clinical outcomes in addition to biological variation and the state-of-the-art. Consideration of APS already in use and the use of results in calculations may also need to be considered to determine the most appropriate APS for use in a specific setting.

Publisher

Walter de Gruyter GmbH

Reference24 articles.

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2. Sandberg, S, Fraser, FG, 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.

3. Jones, GRD, Albarede, S, Kesseler, D, MacKenzie, F, Mammen, J, Pedersen, M, For the EFLM Task Finish Group, et al.. Analytical performance specifications for external quality assessment – definitions and descriptions. Clin Chem Lab Med 2017;55:949–55. https://doi.org/10.1515/cclm-2017-0151.

4. Loh, TP, Smith, AF, Bell, KJL, Lord, SJ, Ceriotti, F, Jones, G, et al.. On behalf of the European federation of clinical chemistry and laboratory medicine task group on outcome- based analytical performance specifications setting analytical performance specifications using HbA1c as a model measurand. Clin Chim Acta 2021;523:407–14. https://doi.org/10.1016/j.cca.2021.10.016.

5. Horvath, AR, Bossuyt, PMM, Sandberg, S, St John, A, Monaghan, PJ, Verhagen-Kamerbeek, WDJ, et al.. For the 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;53:841–8. https://doi.org/10.1515/cclm-2015-0214.

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1. Analytical performance specifications – moving from models to practical recommendations;Clinical Chemistry and Laboratory Medicine (CCLM);2024-06-07

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