Measurement uncertainty estimation technology: justification, conditions and experience of implementation in medical practice
https://doi.org/10.33667/2078-5631-2022-19-7-11
Abstract
In accordance with GOST R ISO 15189–2015 ‘Medical laboratories. Particular requirements for quality and competence’ for the report on the values of the measured value in the patient’s samples, the laboratory must determine and use the measurement uncertainty in the analytical phase. The article discusses in detail the differences between the general analytical error and measurement uncertainty. The authors have tested a typical algorithm for estimating measurement uncertainty. Mandatory conditions and an algorithm for calculating measurement uncertainty (at the analytical stage) in medical laboratories using quantitative immunochemiluminescence analysis are presented.
Keywords
measurement uncertainty,
total error,
quantitative immunochemiluminescence analysis,
quality control
Supporting agencies: The study had no sponsor support
About the Authors
N. A . Kovyazina
EMERCOM of Russia
Russian Federation
Russian Federation
Nadezhda A. Kovyazina, PhD Med, head of Laboratory
The Nikiforov Russian Center of Emergency and Radiation Medicine
Dept of Laboratory Diagnostics
Laboratory of Serological Research and Allergy Diagnostics
Saint Petersburg
N. A . Alkhutova
EMERCOM of Russia
Russian Federation
Russian Federation
Natalya A. Alkhutova, PhD Bio Sci, senior researcher
The Nikiforov Russian Center of Emergency and Radiation Medicine
Dept of Laboratory Diagnostics
Laboratory of Serological Research and Allergy Diagnostics
Saint Petersburg
A. G. Chunovkina
D. I. Mendeleyev Institute for Metrology; Interregional Public Association ‘Metrological Academy’
Russian Federation
Russian Federation
Anna G. Chunovkina, DTech Sci, head of Dept
Metrological Dept
Saint Petersburg
V. L. Emanuel
Interregional Public Association ‘Metrological Academy; Ministry of Health of Russia
Russian Federation
Russian Federation
Vladimir L. Emanuel, DM Sci, professor, academician, director, head of Dept
Pavlov First Saint Petersburg State Medical University
Dept of Clinical Laboratory Diagnostics with a Course in Molecular
Medicine
Scientific and Methodological Centre for Molecular Medicine
Saint Petersburg
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Review
For citations:
Kovyazina N.A., Alkhutova N.A., Chunovkina A.G., Emanuel V.L. Measurement uncertainty estimation technology: justification, conditions and experience of implementation in medical practice. Medical alphabet. 2022;(19):7-11. (In Russ.) https://doi.org/10.33667/2078-5631-2022-19-7-11
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