Comparative study of the test results of medical portable blood glucose meter and biochemical analyzer
Objective To evaluate the performance of medical portable blood glucose meters in clinical blood glucose detection,and to provide a reference for medical institutions to purchase portable blood glucose meters.Methods In this study,five human venous whole blood samples were collected from the First Affiliated Hospital of Wenzhou Medical University on March 10,2024,and the blood glucose concentrations were 1.7 to 3.5 mmol/L,3.5 to 6.1 mmol/L,6.2 to 8.3 mmol/L,8.4 to 13.9 mmol/L,and 14.0 to 25.0 mmol/L.10 blood glucose meters and biochemical analyzers from each of 6 brands were used to repeat the test twice,and the accuracy,precision,relevance and comparability with biochemical analyzers of each brand were evaluated according to the"Guidelines for Clinical Operation and Quality Management of Portable Blood Glucose Meters WS/T781-2021".Results When the blood glucose concentration<5.5 mmol/L,the absolute deviation of the six brands of blood glucose meters was-0.52~+0.54 mmol/L,and the standard deviation(s)was 0.04~0.13mmol/L.When the blood glucose concentration≥5.5 mmol/L,the relative deviation was-19.88%~12.78%,and the coefficient of variation(CV)was 1.3%~3.65%.The correlation coefficient between 6 brands of blood glucose meters and biochemical analyzers was 0.997~0.999,and the coincidence rate of the deviation range of the test results was 91%~100%,of which 5 brands had>coincidence rate95%,and the relative deviation of 1 brand exceeded±15%.Conclusion The precision of the six brands of portable blood glucose meters is good,and there is a good correlation with the detection results of biochemical analyzers.The accuracy of 5 brands of portable blood glucose meters was good,and the accuracy of 1 brand did not meet the requirements of the guidelines.Before adopting a new model of blood glucose meter,it is necessary to verify the precision,accuracy,and relevance of the new blood glucose meter.