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

iLABMED Pub Date : 2024-03-20 DOI:10.1002/ila2.37

Tengjiao Wang, Lina Zhang, Lijun Gong, Yangmei Xin, Liang Han, Na Li, Peng Peng, Xiuying Zhao, Runqing Li

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Abstract

Objective

This 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.

Methods

The 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.

Results

From 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.

Conclusions

Among 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.

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四种血糖监测系统对照五种不同标准在系统准确性可接受性方面的差异

本研究旨在评估四种血糖监测系统（BGMS）的系统准确性，并根据五种不同标准探讨每种血糖监测系统在系统准确性可接受性方面的差异。研究人员将四种血糖监测系统（罗氏Accu-Chek® Performa、拜耳Contour™ TS、华美美迪Glupad® H1 Plus和希诺凯® Gold-Accu）的血糖测量值与中心实验室生化分析仪的参考值进行了对比评估。根据国际标准化组织（ISO）15197:2003、临床实验室标准协会（CLSI）POCT12-A3、ISO 15197:2013、中国检验医学会（CSLM）共识和美国食品和药物管理局（FDA）指南等五项标准的规定，确定了每种BGMS的系统准确性可接受性。从2018年到2022年，从四种BGMS的366台血糖仪中获得了10980对测量值。在 BGMS 的血糖测量值与中心实验室生化分析仪的参考值之间观察到了显著的相关性。罗氏 Accu-Chek® Performa 的相关系数 r 为 0.995，拜耳 Contour™ TS 为 0.994，华美美迪 Glupad® H1 Plus 为 0.983，而 Sinocare® Gold-Accu 为 0.997。罗氏 Accu-Chek® Performa 血糖仪有 100.00% (135/135)、拜耳 Contour™ TS 血糖仪有 100.00% (109/109)、华医美 Glupad® H1 Plus 血糖仪有 81.61% (71/87) 和 Sinocare® Gold-Accu 血糖仪有 100.00% (35/35)符合 ISO 15197:2003 规定的可接受性标准。而罗氏 Accu-Chek® Performa 血糖仪有 99.26% (134/135)、拜耳 Contour™ TS 血糖仪有 88.07% (96/109)、华医美 Glupad® H1 Plus 血糖仪有 58.62% (51/87) 和 Sinocare® Gold-Accu 血糖仪有 91.43% (32/35)符合 ISO 15197:2013 中规定的可接受性标准。对照五种不同标准中规定的可接受性标准，每种血糖仪的系统准确性可接受性都有显著差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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