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Criteria of analytical quality measurement in clinical biochemistry. Current international consensus and its implications for routine action of clinical laboratories.


Authors: B. Friedecký 1,2;  J. Kratochvíla 2
Authors‘ workplace: ÚKBD Fakultní nemocnice Hradec Králové 1;  SEKK s. r. o. Pardubice 2
Published in: Klin. Biochem. Metab., 24, 2016, No. 1, p. 32-38

Overview

Objective:
Review of current opinions on the analytical quality indicators in the clinical laboratoriem.

Method:
In Stockholm Declaration from 1999 are described ways of creating the indicator quality the analytical. These principles are discussed, proposed and recommended for use by the working Group EFLM for specification of requirement on the analytical quality of measurement in clinical laboratories.

Results and discussion:
Relationship between analytical quality parameters and biological variation values. Problems concerned with determination of biological variation values. Total analytical error, bias, measurement of uncertainty-differences, advantages and disadvantages. Necessity in harmonization of tolerance limit values for external quality assessment programs. Relationship between analytical quality and international clinical guidelines is documented.

Conclusions:
Harmonization of indicator quality values in clinical laboratories is necessary for assurance of objective classification in quality of different laboratories and different methods produced by different manufacturers.

Keywords:
quality indicators, EFLM, bias, error, uncertainty, biological variation.


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