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Clinical Chemistry and Laboratory Medicine (CCLM)

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

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Volume 53, Issue 8


Permissible limits for uncertainty of measurement in laboratory medicine

Rainer Haeckel / Werner Wosniok / Ebrhard Gurr / Burkhard Peil
Published Online: 2015-01-23 | DOI: https://doi.org/10.1515/cclm-2014-0874


The international standard ISO 15189 requires that medical laboratories estimate the uncertainty of their quantitative test results obtained from patients’ specimens. The standard does not provide details how and within which limits the measurement uncertainty should be determined. The most common concept for establishing permissible uncertainty limits is to relate them on biological variation defining the rate of false positive results or to base the limits on the state-of-the-art. The state-of-the-art is usually derived from data provided by a group of selected medical laboratories. The approach on biological variation should be preferred because of its transparency and scientific base. Hitherto, all recommendations were based on a linear relationship between biological and analytical variation leading to limits which are sometimes too stringent or too permissive for routine testing in laboratory medicine. In contrast, the present proposal is based on a non-linear relationship between biological and analytical variation leading to more realistic limits. The proposed algorithms can be applied to all measurands and consider any quantity to be assured. The suggested approach tries to provide the above mentioned details and is a compromise between the biological variation concept, the GUM uncertainty model and the technical state-of-the-art.

Keywords: measurement uncertainty; permissible bias; permissible imprecision


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About the article

Corresponding author: Rainer Haeckel, Bremer Zentrum für Laboratoriumsmedizin, Klinikum Bremen Mitte, 28305 Bremen, Germany, Phone: +49 412 273448, E-mail:

Received: 2014-09-01

Accepted: 2014-11-13

Published Online: 2015-01-23

Published in Print: 2015-07-01

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 8, Pages 1161–1171, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0874.

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