Horovskaia L A, Lobachevskaia T V, Chernichuk O V
Klin Lab Diagn. 2015 Jan;60(1):60-3.
The modern laboratory medicine provides observation of requirements to glucometers in line with standard DIN EN ISO 15197-2:2013 for self-control under treatment of patients with diabetes mellitus and registration of biologic types data. The study compared functioning of diagnostic devices in point-of-care of four manufacturers. The samples of whole blood taken from two patients were analyzed in three lots of test-strips with concentration of glucose 4.5 and 11.8 mmol/l using glucometers Accu-Chek Active, One Touch Select, Sattelite Express and Contour TS and reference analyzer Olympus AU 400. The results of measurements were analyzed using technique of separated test of patient. The results demonstrated that precision indicators of measurement of blood glucose on glucometers Accu-Chek Active and One Touch Select were within the scope of quality criteria DIN EN ISO 15197-2:2013. The results of testing of glucometer Sattelite Express exceeded the given criteria under measurement of normoglycemic level of concentration and for Contour TS in all range of measured values.
现代检验医学根据标准DIN EN ISO 15197-2:2013对血糖仪进行观察，以用于糖尿病患者治疗期间的自我监测及生物类型数据记录。该研究比较了四个制造商的即时检验诊断设备的性能。使用Accu-Chek Active血糖仪、One Touch Select血糖仪、Sattelite Express血糖仪、Contour TS血糖仪以及参考分析仪Olympus AU 400，对从两名患者采集的全血样本，在三批葡萄糖浓度分别为4.5 mmol/l和11.8 mmol/l的测试条上进行分析。测量结果采用患者单独测试技术进行分析。结果表明，Accu-Chek Active血糖仪和One Touch Select血糖仪的血糖测量精密度指标在DIN EN ISO 15197-2:2013质量标准范围内。Sattelite Express血糖仪在测量正常血糖浓度水平时以及Contour TS血糖仪在所有测量值范围内的测试结果均超出了给定标准。
