Validation of the blood glucose testing method on the Accu-chek Inform II

Abstract

Blood glucose testing, including capillary blood glucose, is the recommended test for the diagnosis and monitoring of diabetes treatment. Currently, capillary blood glucose testing is performed on point-of-care testing (POCT) with reasonable cost, fast time, convenience, supporting timely diagnosis and treatment. However, in order to select POCT devices that meet quality standards, it is necessary to strictly control the laboratory. Object and method: Confirmation of the capillary blood sugar testing method on the Accu-chek Inform II (Acc-II) machine including the following indicators: accuracy, precision, linear range, comparison of test results according to the recommendations of the Clinical & Laboratory Standards Institute (CLSI) (EP15A3, EP06A, EP09A3). The authors compared results on the testing machine in the central laboratory (Cobas 8000) of blood glucose testing on the POCT machine with the results of whole capillary blood, whole venous blood, and plasma venous samples. Results: Precision, accuracy, and linearity were confirmed as published. The linear range of the method is from 1.6 to 31 mmol/l. The difference between capillary blood glucose pairs and plasma venous glucose, whole blood venous glucose on Accu-chek Inform II and plasma venous blood glucose on Cobas 8000 machine are 6.89, -8.62, and -10.97%, respectively.