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新型“血浆参考”即时检验血糖监测系统——它们适用于血糖监测和糖尿病诊断吗?

New "plasma referenced" POCT glucose monitoring systems--are they suitable for glucose monitoring and diagnosis of diabetes?

作者信息

Savoca Reto, Jaworek Beata, Huber Andreas R

机构信息

Center for Laboratory Medicine, Kantonspital Aarau, CH-5001 Aarau, Switzerland.

出版信息

Clin Chim Acta. 2006 Oct;372(1-2):199-201. doi: 10.1016/j.cca.2006.03.012. Epub 2006 May 12.

Abstract

BACKGROUND

Results from portable glucose meters should be reported as plasma values as recommended by IFCC. Three new "plasma calibrated" blood glucose meters (Abbott Precision Xcceed, Bayer Ascensia Contour and Roche Accu-Chek Aviva) were compared against laboratory venous plasma glucose measurements to determine their suitability for patient monitoring and diabetes diagnosis.

METHODS

115 capillary blood samples were analyzed on each of the three meters and compared to venous plasma measurements on the Dade Behring RXL analyzer (Hexokinase method).

RESULTS

We found a significant positive bias of all meters compared to the laboratory reference method. Deviations of more than 10% were seen in more than a third of all glucose values in all three devices. 13%, 8.7% and 10.4%, respectively, of the values from the Abbott, Bayer and Roche devices fell in zone B or C of the Parkes' error grid.

CONCLUSIONS

Neither glucose meter met the ADA or the NACB goals and should therefore not be used as screening tests to diagnose diabetes but are well suitable for patient monitoring.

摘要

背景

按照国际临床化学和检验医学联合会(IFCC)的建议,便携式血糖仪的检测结果应以血浆值形式报告。将三款新型“血浆校准”血糖仪(雅培Precision Xcceed、拜耳Ascensia Contour和罗氏Accu-Chek Aviva)与实验室静脉血浆葡萄糖测量结果进行比较,以确定它们在患者监测和糖尿病诊断方面的适用性。

方法

对三款血糖仪分别分析115份毛细血管血样本,并与Dade Behring RXL分析仪(己糖激酶法)检测的静脉血浆结果进行比较。

结果

与实验室参考方法相比,我们发现所有血糖仪均存在显著的正偏差。在所有三款设备中,超过三分之一的葡萄糖值偏差超过10%。雅培、拜耳和罗氏设备测得的值分别有13%、8.7%和10.4%落在帕克斯误差网格的B区或C区。

结论

三款血糖仪均未达到美国糖尿病协会(ADA)或美国临床生物化学学会(NACB)的目标,因此不应作为糖尿病诊断的筛查测试,但非常适合患者监测。

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