Jump to ContentJump to Main Navigation
Show Summary Details
More options …

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

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

12 Issues per year


IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

SCImago Journal Rank (SJR) 2016: 1.000
Source Normalized Impact per Paper (SNIP) 2016: 1.112

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 55, Issue 11 (Oct 2017)

Issues

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

Abstract

Background:

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

Methods:

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.

Results:

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.

Conclusions:

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

References

  • 1.

    ISO 15189: Medical laboratories – particular requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2012.Google Scholar

  • 2.

    JCGM 200:2012. International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM 3rd edition). Available at: www.bipm.org. Accessed: Nov 2016.

  • 3.

    Oosterhuis WP, Theodorsson E. Total error vs. measurement uncertainty: revolution or evolution? Clin Chem Lab Med 2016;54:235–9.Google Scholar

  • 4.

    Jones GRD. Measurement uncertainty for clinical laboratories – a revision of the concept. Clin Chem Lab Med 2016;54:1303–7.Web of ScienceGoogle Scholar

  • 5.

    Sandberg S, Fraser CG, 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.PubMedWeb of ScienceGoogle Scholar

  • 6.

    White GH. Basics of estimating measurement uncertainty. Clin Biochem Rev 2008;29:Suppl 1:S53–60.PubMedGoogle Scholar

  • 7.

    JCGM 100:2008. Evaluation of measurement data – Guide to the expression of uncertainty in measurement, with minor corrections (GUM). Available at: www.bipm.org. Accessed: Sept 2016.

  • 8.

    Westgard JO. Useful measures and models for analytical quality management in medical laboratories. Clin Chem Lab Med. 2016;54:223–33.PubMedWeb of ScienceGoogle Scholar

  • 9.

    Farrance I, Badrick T, Sikaris KA. Uncertainty in measurement and total error – are they so incompatible? Clin Chem Lab Med 2016;54:1309–11.Web of ScienceGoogle Scholar

  • 10.

    Tate JR, Plebani M. Measurement uncertainty – a revised understanding of its calculation and use. Clin Chem Lab Med 2016;54:1277–9.Web of ScienceGoogle Scholar

  • 11.

    Matar G, Poggi B, Meley R, Bon C, Chardon L, Chikh K, et al. Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data. Clin Chem Lab Med 2015;53:1725–36.Web of ScienceGoogle Scholar

  • 12.

    Nordic Innovation. Handbook for calculation of measurement uncertainty in environmental laboratories. NT TR 537 – Edition 3.1, 2012. Available at: www.nordtest.info. Accessed: Sept 2016.

  • 13.

    Guide to the evaluation of measurement uncertainty for quantitative test results. Technical Committee for Quality Assurance in Testing (TCQA). EUROLAB Technical Report No. 1/2006.Google Scholar

  • 14.

    Quantifying Uncertainty in Analytical measurement. Eurachem/CITAC Guide CG 4, 3rd ed. Available at: www.eurachem.org. Accessed: Nov 2016.

  • 15.

    ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison. Geneva: International Organization for Standardization (ISO), 2012.Google Scholar

  • 16.

    James D, Ames D, Lopez B, Still R, Simpson W, Twomey P. External quality assessment: best practice. J Clin Pathol 2014;67:651–5.CrossrefWeb of SciencePubMedGoogle Scholar

  • 17.

    Tran MT, Hoang K, Greaves RF. Practical application of biological variation and Sigma metrics quality models to evaluate 20 chemistry analytes on the Beckman Coulter AU680. Clin Biochem 2016;49:1259–66.CrossrefWeb of SciencePubMedGoogle Scholar

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), ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2016-0896.

Export Citation

©2017 Walter de Gruyter GmbH, Berlin/Boston. Copyright Clearance Center

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]

Comments (0)

Please log in or register to comment.
Log in