Tengjiao Wang, Lina Zhang, Lijun Gong, Yangmei Xin, Liang Han, Na Li, Peng Peng, Xiuying Zhao, Runqing Li
{"title":"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","authors":"Tengjiao Wang, Lina Zhang, Lijun Gong, Yangmei Xin, Liang Han, Na Li, Peng Peng, Xiuying Zhao, Runqing Li","doi":"10.1002/ila2.37","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>The glucose measurement values obtained from four types of BGMSs (Roche Accu-Chek<sup>®</sup> Performa, Bayer Contour™ TS, Sinomedisite Glupad<sup>®</sup> H1 Plus, and Sinocare<sup>®</sup> 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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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 <i>r</i> was 0.995 for Roche Accu-Chek<sup>®</sup> Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad<sup>®</sup> H1 Plus, and 0.997 for Sinocare<sup>®</sup> 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<sup>®</sup> Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 100.00% (35/35) of Sinocare<sup>®</sup> 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<sup>®</sup> Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 91.43% (32/35) of Sinocare<sup>®</sup> Gold-Accu.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Among the four types of BGMSs evaluated, the glucose meters of Roche Accu-Chek<sup>®</sup> Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.</p>\n </section>\n </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"70-78"},"PeriodicalIF":0.0000,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.37","citationCount":"0","resultStr":"{\"title\":\"Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards\",\"authors\":\"Tengjiao Wang, Lina Zhang, Lijun Gong, Yangmei Xin, Liang Han, Na Li, Peng Peng, Xiuying Zhao, Runqing Li\",\"doi\":\"10.1002/ila2.37\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>The glucose measurement values obtained from four types of BGMSs (Roche Accu-Chek<sup>®</sup> Performa, Bayer Contour™ TS, Sinomedisite Glupad<sup>®</sup> H1 Plus, and Sinocare<sup>®</sup> 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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 <i>r</i> was 0.995 for Roche Accu-Chek<sup>®</sup> Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad<sup>®</sup> H1 Plus, and 0.997 for Sinocare<sup>®</sup> 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<sup>®</sup> Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 100.00% (35/35) of Sinocare<sup>®</sup> 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<sup>®</sup> Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 91.43% (32/35) of Sinocare<sup>®</sup> Gold-Accu.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Among the four types of BGMSs evaluated, the glucose meters of Roche Accu-Chek<sup>®</sup> Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.</p>\\n </section>\\n </div>\",\"PeriodicalId\":100656,\"journal\":{\"name\":\"iLABMED\",\"volume\":\"2 2\",\"pages\":\"70-78\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-03-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.37\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"iLABMED\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/ila2.37\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"iLABMED","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ila2.37","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards
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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