Evaluation of measurement uncertainty at establishing metrological traceability of results of clinical studies of biological samples

Chunovkina A.G.

doi:https://doi.org/10.17116/labs2020903132

Chunovkina A.G.

D.I. Mendeleyev Institute for Metrology

Evaluation of measurement uncertainty at establishing metrological traceability of results of clinical studies of biological samples

Authors:

Chunovkina A.G.

More about the authors

Journal: Laboratory Service. 2020;9(3): 32‑40

DOI: 10.17116/labs2020903132

Read: 12322 times

Download PDF (RU)

Contact the author

Table of contents

To cite this article:

Chunovkina AG. Evaluation of measurement uncertainty at establishing metrological traceability of results of clinical studies of biological samples. Laboratory Service. 2020;9(3):32‑40. (In Russ.)
https://doi.org/10.17116/labs2020903132

Подписка 2025 Лабораторная служба (Laboratory Service)

Использование инфографики авторами научных работ

Close metadata

Abstract:

The paper considers the problem of measurement uncertainty evaluation when establishing metrological traceability of measurement results of biological samples parameters to the level of primary reference measurement proceduress/calibrators or internationally recognized reference measurement procedures/ calibrators. The GUM approach, based on the use of a measurement model and applied by calibration laboratories is briefly considered. Empirical approach for evaluating measurement uncertainty, which is based on the information available in clinical laboratories, is also considered.

Keywords:

measurement uncertainty

measurement accuracy

measurement precision

measurement trueness

measurement traceability

calibration hierarchy

Authors:

Chunovkina A.G.

D.I. Mendeleyev Institute for Metrology

Received:

26.05.2020

Accepted:

23.07.2020

Close metadata

References:

GOST R ISO 15189:2015 Laboratorii medicinskie. Chastnye trebovaniya k kachestvu i kompetentnosti. (In Russ.).
GOST R ISO 15195:2006 Laboratornaya medicina. Trebovaniya k laboratoriyam referentnyh izmerenij. (In Russ.).
ISO 15195:2018 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures. (In Russ.).
GOST ISO/MEK 17025-2009 Obshchie trebovaniya k kompetentnosti ispytatel’nyh i kalibrovochnyh laboratorij. (In Russ.).
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.
GOST ISO 17511-2011 Izdeliya medicinskie dlya diagnostiki in vitro. Izmerenie velichin v biologicheskih probah. Metrologicheskaya proslezhivaemost’ znachenij, pripisannyh kalibratoram i kontrol’nym materialam. (In Russ.).
JCGM 100:2008 Evaluation of measurement data — Guide to the expression of uncertainty in measurement (GUM).
GOST 34100.1-2017/ISO/IEC Guide 98-1:2009 Neopredelennost’ izmereniya. CHast’ 1. Vvedenie v rukovodstva po vyrazheniyu neopredelennosti izmereniya. (In Russ.).
GOST 34100.3.1-2017/ISO/IEC Guide 98-3/Suppl 1:2008 Neopredelennost’ izmereniya. CHast’ 3. Rukovodstvo po vyrazheniyu neopredelennosti izmereniya. Dopolnenie 1. Transformirovanie raspredelenij s ispol’zovaniem metoda Monte-Karlo. (In Russ.).
GOST 34100.3.2-2017/ISO/IEC Guide 98-3/Suppl 2:2011 Neopredelennost’ izmereniya. CHast’ 3. Rukovodstvo po vyrazheniyu neopredelennosti izmereniya. Dopolnenie 2. Obobshchenie na sluchaj proizvol’nogo chisla vyhodnyh velichin. (In Russ.).
GOST R ISO 5725 Tochnost’ (pravil’nost’ i precizionnost’) metodov i rezul’tatov izmerenij. Chast’ 1—6. (In Russ.).
GOST R ISO 21748-2012 Statisticheskie metody. Rukovodstvo po ispol’zovaniyu ocenok povtoryaemosti, vosproizvodimosti i pravil’nosti pri ocenke neopredelennosti izmerenij. (In Russ.).
Rukovodstvo EVRAHIM/SITAK CG 4 Kolichestvennoe opisanie neopredelennosti v analiticheskih izmereniyah. Tret’e izdanie (2012). (In Russ.).
ISO/TS 20914:2019 Medical laboratories — Practical guidance for the estimation of measurement uncertainty.