Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards

Abstract

ObjectiveThis study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.MethodsThe glucose measurement values obtained from four types of BGMSs (Roche Accu‐Chek® Performa, Bayer Contour™ TS, Sinomedisite Glupad® H1 Plus, and Sinocare® Gold‐Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12‐A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.ResultsFrom 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient r was 0.995 for Roche Accu‐Chek® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad® H1 Plus, and 0.997 for Sinocare® Gold‐Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu‐Chek® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad® H1 Plus, and 100.00% (35/35) of Sinocare® Gold‐Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu‐Chek® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad® H1 Plus, and 91.43% (32/35) of Sinocare® Gold‐Accu.ConclusionsAmong the four types of BGMSs evaluated, the glucose meters of Roche Accu‐Chek® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.