Performance Evaluation of Two Glucometers: RIGHTEST TM GM700S and RIGHTEST TM GM550 from Bionime

Abstract

Glucometers are medical devices that provide glycemic monitoring. On-site verification of the performance of a glucometer is a requirement of ISO 22870. Thus, the objective of this study was to evaluate the performance of two glucometers (RIGHTEST TM GM700S and GM550). This is a prospective analytical study, carried out at the Biochemistry-Hematology Laboratory of the Fann University Hospital. The parameters studied were venous glycemia and capillary glycemia. The main evaluation parameters used were: repeatability, reproducibility, estimation of accuracy and comparison of methods. The performance criteria used were those of the French Society of Clinical Biology (SFBC) and the DIN EN ISO 15197: 2013 standard. The coefficients of variation of reproducibility (1.88%; 2.2%) and repeatability (1.93%; 1.8%) of the two glucometers complied with the SFBC criteria. The accuracy estimate showed a bias of −15% in accordance with the requirements of DIN EN ISO 15197:2013. The comparison of capillary glycemia values and those obtained with the reference automatons showed satisfactory linearity and good agreement. The glucometers showed acceptable performance compared to the accepted standards. They are suitable for self-monitoring of glycemia levels in diabetic patients.