Quality, control and validation of glucometers and CGM systems. Status overview

Česká verzia

Authors: B. Friedecký ^1,2; J. Kratochvíla ²; D. Springer ³
Authors place of work: Ústav klinické biochemie a diagnostiky Fakultní nemocnice Hradec Králové ¹; SEKK s. r. o. Pardubice ²; Ústav lékařské biochemie a laboratorní diagnostiky 1. LF UK a VFN Praha ³
Published in the journal: Klin. Biochem. Metab., 24, 2016, No. 2, p. 75-81

Summary

The communication deals with current state of analytical quality for measuring the glucose in blood by glucometers and continuous glucose monitoring (CGM).Quality requirements for blood glucose measurement of ISO 15197 and FDA 2014 standards are described and results of recent studies of their evaluations in used glucometers are introduced. These results show very different level of quality in glucometers and high degree of lot-to-lot variation. Also, programs of external quality assessment provide similar picture on measurement quality. We describe current limited possibilities of control materials in quality assessment, namely in case of bias determination. Quality requirements based on recommendations of US FDA guidance is also part of this publication. We summarize the recent state of quality measurement of continuous glucose monitoring.

Keywords:
Glucometers, continuous monitoring of glucose, quality requirements, quality assessment.

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