Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales
Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales
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DOI：
10.1136/jclinpath-2015-203339
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发表时间：
2016-10-01
影响因子：
3.4
通讯作者：
Reynolds, Timothy
中科院分区：
文献类型：
--
作者：
Sutheran, Hannah Lise;Reynolds, Timothy
目的：即时检测（POCT）葡萄糖系统的制造商必须遵守国际标准化组织（ISO） 15197性能标准，该标准的严格版本将于2016年5月强制执行。采用偏离ISO 15197评价要求的方法，我们研究了三种葡萄糖检测系统的准确性和临床实用性。方法测定62例edta保存标本的全血血糖，并用实验室己糖激酶法测定血浆血糖。采用线性回归、Bland-Altman图和偏倚评估技术准确性。临床效用评估采用共识误差网格分析和胰岛素给药算法。结果与比较法的相关系数为0.979 ~ 0.993 （n=61）。对参考方法的偏倚为+0.7-+4.4%。FreeStyle Lite（0.74.4%）和ACCU-CHEK Aviva（1.3 +/- 7.3%）系统对参考的偏差最小。误差网格分析描述了所有仪表的临床准确性，所有结果都在A区和b区范围内。结论：合格的欧洲标记设备被认为具有足够的准确性，但上市后评估是必要的，以评估总体系统准确性和是否达到监管目标。
Aims Manufacturers of point-of-care testing (POCT) glucose systems must adhere to International Organisation for Standardisation (ISO) 15197 performance standards, a tightened version of which becomes mandatory in May 2016. Using methods deviating from the evaluation requirements of ISO 15197, we investigated the accuracy and clinical utility of three glucose testing systems.Methods Whole blood glucose was measured on 62 EDTA-preserved samples with each system followed by plasma glucose determination with a laboratory hexokinase method. Technical accuracy was assessed using linear regression, Bland-Altman plots and bias. Clinical utility was evaluated using consensus error grid analysis and insulin dosing algorithms.Results The correlation coefficient of the glucose measuring devices with the comparator method was between 0.979 and 0.993 (n=61). Bias against the reference method was +0.7-+4.4%. The FreeStyle Lite (0.74.4%) and ACCU-CHEK Aviva (1.3 +/- 7.3%) systems had the least bias to the reference. Error grid analysis depicts all meters to be clinically accurate, with all results falling within Zones A and B.Conclusions Conformite Europeene-marked devices are presumed to have adequate accuracy, but postmarket evaluations are imperative to assess total system accuracy and whether regulatory targets are achieved.