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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

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Volume 55, Issue 11


An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

Andrea Padoan
  • Corresponding author
  • Department of Medicine – DIMED, University of Padova, Padova, Italy
  • Department of Laboratory Medicine, University-Hospital of Padova, via Giustiniani 2, 35128, Padova, Italy, Phone: +390498212801, Fax: +390498211981
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Giorgia Antonelli
  • Department of Medicine – DIMED, University of Padova, Padova, Italy
  • Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Ada Aita
  • Department of Medicine – DIMED, University of Padova, Padova, Italy
  • Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Laura Sciacovelli / Mario PlebaniORCID iD: http://orcid.org/0000-0002-0270-1711
Published Online: 2017-02-28 | DOI: https://doi.org/10.1515/cclm-2016-0896



The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).


The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.


A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.


The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

Keywords: external quality assessment schemes (EQAs); internal quality controls (IQC); ISO 15189; measurement procedures (MPs); measurement uncertainty (MU); medical laboratory accreditation


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About the article

Received: 2016-10-06

Accepted: 2017-01-18

Published Online: 2017-02-28

Published in Print: 2017-10-26

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 55, Issue 11, Pages 1696–1701, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2016-0896.

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