Variability between batches of reagents and calibrators and its consequences for measurement verification
2016
Abstract
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