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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Clinical biochemistry Nuclear medicine Nutritive therapistArticle was published in
Clinical Biochemistry and Metabolism
2016 Issue 4
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