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两种兽医校准的即时血糖仪测量犬血糖浓度的准确性比较。

Comparative accuracy of two veterinary-calibrated point-of-care glucometres for measurement of blood glucose concentration in dogs.

机构信息

Animalius Vet, Bayswater, 6053, Australia.

School of Veterinary Medicine and Centre for Biosecurity and One Health, Murdoch University, Murdoch, 6150, Australia.

出版信息

J Small Anim Pract. 2022 Jul;63(7):512-519. doi: 10.1111/jsap.13491. Epub 2022 Mar 28.

Abstract

OBJECTIVES

To investigate and compare the accuracy of two veterinary portable blood glucose metres (AccuTell; AccubioTech; and AlphaTrak2; Abbott Laboratories).

MATERIALS AND METHODS

One hundred twenty venous blood samples were obtained for immediate whole blood glucose concentration measurement using two portable blood glucose metres designed for use in dogs. Plasma glucose concentration was measured by a laboratory analyser using a hexokinase reaction method. Packed cell volume was measured for each sample. Linear regression analysis was performed and Bland-Altman plots constructed with International Standards Organisation 15197:2013 standards applied to assess relationship and agreement between results of portable blood glucose metres and laboratory analyser methods, respectively. Clarke's error grid analysis was used to assess clinical accuracy and usefulness.

RESULTS

The AccuTell and the AlphaTrak2 had mean differences of -0.69 ± 0.70 mmol/L (bias ±sd) and -1.09 ± 1.22 mmol/L (bias ± sd) with the reference analyser, respectively. Eighty-eight of 120 (73.3%) samples for the AccuTell, and 73 of 120 (60.8%) samples for the AlphaTrak2 were plotted in the zone of the error grid analysis that indicated less clinical risk of misdiagnosis of glucose status. Neither device fulfilled the International Standards Organisation 15197:2013 standards for system accuracy. A statistically significant effect of packed cell volume was identified on the difference between blood glucose concentration obtained by the AlphaTrak2 and the hexokinase reaction method, but not for the AccuTell.

CLINICAL SIGNIFICANCE

Both devices do not meet International Standards Organisation 15197:2013 standards. Users should expect 95% of the samples measured with the AccuTell to be between -0.7 and +2.1 mmol/L higher than actual values, and 95% of the samples measured with the AlphaTrak2 to be between -1.3 and +3.5 mmol/L higher than actual values.

摘要

目的

研究并比较两款兽医便携式血糖仪(AccuTell;AccubioTech;和 AlphaTrak2;雅培实验室)的准确性。

材料和方法

采集 120 份静脉血样,立即使用专为犬类设计的两款便携式血糖仪进行全血血糖浓度测量。使用基于己糖激酶反应的实验室分析仪测量血浆葡萄糖浓度。为每个样本测量红细胞压积。使用线性回归分析和 Bland-Altman 图,分别应用国际标准化组织 15197:2013 标准评估便携式血糖仪和实验室分析仪方法的结果之间的关系和一致性。Clarke 误差网格分析用于评估临床准确性和实用性。

结果

AccuTell 和 AlphaTrak2 与参考分析仪的平均差值分别为-0.69±0.70mmol/L(偏差±标准差)和-1.09±1.22mmol/L(偏差±标准差)。AccuTell 有 88/120(73.3%)样本,AlphaTrak2 有 73/120(60.8%)样本落在误差网格分析的区域,表明葡萄糖状态误诊的临床风险较低。两种设备均不符合国际标准化组织 15197:2013 标准的系统准确性。红细胞压积对 AlphaTrak2 与己糖激酶反应方法之间血糖浓度差异的影响有统计学意义,但对 AccuTell 没有影响。

临床意义

两款设备均不符合国际标准化组织 15197:2013 标准。用户应预计 AccuTell 测量的 95%的样本值比实际值高 0.7 至 2.1mmol/L,AlphaTrak2 测量的 95%的样本值比实际值高 1.3 至 3.5mmol/L。

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