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Variability between batches of reagents and calibrators and its consequences for measurement verification


Authors: B. Friedecký
Authors‘ workplace: ÚKBD Fakultní nemocnice, Hradec Králové
Published in: Klin. Biochem. Metab., 24, 2016, No. 4, p. 170-172

Overview

We deals with recently published data on the lot-to-lot variation in laboratory measurements by some important analytes. This variability can reach in some cases more than 10 %. We discuss possible significant impacts for diagnostic processes and also for external quality assessment. Lot-to-lot variability in the diagnostic strips of glucose POCT and self-monitoring measurement systems are applied as integral part of ISO 15197 standard. We introduce ways and possibilities for establishment and assessment of these variations. Quantification and documentation of lot-to-lot variation is necessary tool for verification of measurement methods in clinical laboratories.

Keywords:
lot, reagents, calibrators, variation, verification.


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