Abstract
The accuracy of glucose meters is evaluated by comparing their results with those from a reference laboratory glucose analyser. The main scientific societies recommend the use of a prompt glycolysis inhibitor such as citrate for an accurate glucose determination. In the present preliminary study, we discuss the bias between capillary and plasma glucose measured concentrations, determined in two Italian clinical laboratories, using tubes containing an NaF and citrate mixture in liquid and granular form. 139 volunteers in whom 75 g OGTT was requested were recruited. Basal capillary glucose was determined using Abbott FreeStyle Precision Neo in Brescia (n=63), while clinical laboratory reference P-glucose was determined using tubes containing NaF/K3EDTA and liquid NaF/Na2EDTA/citrate. Basal capillary glucose was determined using a Roche Cobas Accu-Chek Inform II in Vicenza (n=76), while P-glucose was determined using tubes containing NaF/K2Ox and NaF/Na2EDTA/citrate in granulated form. Reference P-glucose was determined with a hexokinase method on Dimension Vista systems. Differences between capillary and reference P-glucose were evaluated according to ADA/ISO 15197:2013 specifications. 96.82% and 97.37% of capillary determinations were within specifications when liquid and granular citrate mixture tubes were used, respectively. Conversely, only 73.02% and 80.26% of determinations were within criteria using NaF. It's important to know what is the laboratory reference glucose in evaluating glucose meters' accuracy. The evaluation of glucometers' accuracy with respect to a reference laboratory may be wrong if tubes containing only NaF are used due to in vitro glycolysis. Only tubes containing citrate mixture permit the correct evaluation of glucose meters' accuracy.
Highlights
The measurement of glucose represents a cornerstone in the diagnosis of carbohydrate metabolism disorders and in the care of all people with diabetes [1]
The median glucose concentration in the whole blood capillary sample using the Abbott FreeStyle Precision Neo glucose meter (n=63) was 5.11 (IQR:4.68–5.50–99.0) mmol/L, and reference venous plasma glucose using tubes containing NaF/K3EDTA was 4.46 (IQR:4.13–4.95) mmol/L (p
The median glucose concentration in the whole blood capillary sample using the Roche Cobas AccuChek Inform II glucose meter (n=76) was 5.22 (IQR: 4.78–5.83) mmol/L, and reference venous plasma glucose using tubes containing NaF/K2Ox was 4.64 (IQR: 4.11–5.17) mmol/L (p
Summary
The measurement of glucose represents a cornerstone in the diagnosis of carbohydrate metabolism disorders and in the care of all people with diabetes [1]. Glucose meters are easy to use and cost-effective and have become the method of choice in many laboratories in the context of the evaluation of basal glucose determination in the Oral Glucose Tolerance Test (OGTT). Multiple performance goals have been proposed for portable glucose meters. The international standard ISO 15197:2013 specifies the same criteria for accuracy of glucose meters but introduces a second trueness criterion relating to the consensus error grid that assigns pairs of glucose meters’ results and a corresponding reference value to a clinical risk zone: at least 99% of results have to be within the consensus error zones A and B [4]. The Food and Drug Administration (FDA) 2016 criteria state that 95% of glucose values must be within 15% of reference and 99% of glucose values must be within 20% of reference [6]
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