What the Milan conference has taught us about analytical performance specification model definition and measurand allocation-Reference-Cited by-同舟云学术

What the Milan conference has taught us about analytical performance specification model definition and measurand allocation

Published:2024-01-25 Issue:0 Volume:0 Page:
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Panteghini Mauro¹^ORCID

Affiliation:

1. Department of Laboratory Medicine , Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun , Torun , Poland

Abstract

Abstract Analytical performance specifications (APS) represent the criteria that specify the quality required for laboratory test information to satisfy clinical needs. In 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) considered timely to update the topic of APS by organizing a conference in Milan in which some strategic concepts were proposed. Here I summarize the essential points representing the EFLM Strategic Conference heritage and discuss the approaches that will permit us to become more concrete, including roles and main actions expected from each of involved stakeholders for contributing a quantum leap forward in the way of practicality of Milan consensus about APS.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2023-1257/pdf

Reference63 articles.

1. Tonks, DB. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963;9:217–33. https://doi.org/10.1093/clinchem/9.2.217.

2. Cotlove, E, Harris, EK, Williams, GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medical implications. Clin Chem 1970;16:1028–32. https://doi.org/10.1093/clinchem/16.12.1028.

3. Elevitch, FR, editor. College of American Pathologists Conference II (1976): Analytical goals in clinical chemistry. Skokie, IL: College of American Pathologists; 1977.

4. Fraser, CG, Hyltoft Petersen, P, Ricos, C, Haeckel, R. Proposed quality specifications for the imprecision and inaccuracy of analytical systems in clinical chemistry. Eur J Clin Chem Clin Biochem 1992;30:311–7.

5. Stockl, D, Baadenhuisjen, H, Fraser, CG, Libeer, JC, Hyltoft Petersen, P, Ricós, C. Desirable routine analytical goals for quantities assayed in serum. Eur J Clin Chem Clin Biochem 1995;33:157–69.