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МНОГОЦЕНТРОВОЕ КЛИНИКОЛАБОРАТОРНОЕ ИССЛЕДОВАНИЕ ТОЧНОСТИ ПОРТАТИВНОГО ГЛЮКОМЕТРА 'САТЕЛЛИТ ПЛЮС'

机译:便携式血糖仪“ SATELLIT PLUS”准确性的多中心临床实验室测试

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摘要

The analysis of 482 blood samples of patients with diabetes meltitus type I and II and healthy persons was made using the portative ghicometer "Satellite Plus". The comparison with reference analyzer was made. The results of clinical laboratory tests demonstrated that this glucometer meets the precision requirements of inter-national standard ISO 15197:2003 (97.5% of results are in the limits of standard deviation). The evaluation of results using the technique of analysis of errors array for patients with diabetes mellitus type 1 demonstrated that 99.4% (479 out of 482) were in zone A i.e. are clinically accurate results. The measurement results capable to negatively impact the clinical course of disease, to represent significant medical risk and to result in dangerous outcomes were not registered. So, the portative glu-cometer "Satellite Plus" can be recommended to detect the concentration ofglu-cose in capillary blood for self-control of the glycaemia level in patients with dia-betes mellitus. The device can be applied too for express-diagnostics in conditions of emergency medical care rendering by medical personnel.
机译:使用便携式重力计“ Satellite Plus”对I和II型糖尿病患者进行了482份血液样本分析。与参考分析仪进行了比较。临床实验室测试的结果表明,该血糖仪符合国际标准ISO 15197:2003的精度要求(97.5%的结果在标准偏差的范围内)。使用错误阵列分析技术对1型糖尿病患者的结果评估显示99.4%(482个样本中的479个)位于A区,即临床上准确的结果。没有对能够消极影响疾病临床进程,代表重大医疗风险并导致危险结果的测量结果进行记录。因此,建议使用便携式血糖仪“ Satellite Plus”来检测毛细血管血液中的血糖浓度,以自我控制糖尿病患者的血糖水平。该设备还可用于医护人员在紧急医疗护理情况下的快速诊断。

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