ABSTRACT
Objective To evaluate the precision and accuracy of blood glucose meter(BGM ) for community home use testing . Methods According to the In Vitro Diagnostic Test Systems‐Requirements for Blood Glucose Monitoring Systems for Self‐Testing in Managing Diabetes Mellitus in DIN EN ISO15197 :2013 .Capillary blood and venous blood were tested by BGM and the laborato‐ry biochemical analyzer respectively .The measurement results of each BGM were compared with the results of the biochemical ana‐lyzer for conducting the bias analysis .Results In evaluated 20 BGM ,none of them met the requirements of ISO15197 :2013(when blood glucose concentrations < 5 .5 mmol/L ,the bias in 95% of detection results is within the range of ± 0 .83 mmol/L ;when blood glucose concentrations ≥ 5 .5 mmol/L ,the bias in 95% of detection results is within the range of ± 15% .Only 11 imported BGM (55% ) met the state standard .Conclusion The bias of 20 BGM ranged - 28 .7% - 3 .8% ,with the average bias of - 12 .2% . These detection results will bring the large risk of therapy in the diabetic patients .The regular and standardized evaluation of BGM performance may ensure the quality of blood glucose self - monitoring .
ABSTRACT
Objective The monoclone antibody against insulin was prepared and used to measure plasma level of insulin in patients with type 2 diabetes mellitus. Methods Balb/c mice were immunedwith cross-linking insulin-BSA as immunogen. Four monoelone cell strains stably secreting insulin monoclone antibody were prepared by applying hybridoma technique. The valence, subclass and affini-ty constant of the monoclone antibody were analyzed. The serum insulin content was measured with competitive inhibition ELISA in 90 patients with type 2 diabetes mellitus and 90 healthy controls. Re-suits The affinity constant of the established monoclone antibody reached to 1011. The subclass of 1 strain was Igab(k),and the other 3 strains were Ig1(k) srbclass.The mean level of insulin was significantly lower in patients with type 2 diabetes mellitus than that of healthy controls. Conclusion These results implicated that the insulin insufficient might be due to the depletion of the pancreatic be-ta cell function of patients with type 2 diabetes mellitus, and the pathogenetic condition might be alle-viated by supplying insulin. About 10% patients are with higher insulin level than healthy controls,which may be due to insulin resistance. It is inadvisable to treat these patients with insulin therapy.