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在临床环境中,一款β原型血糖仪设备与参考实验室标准之间对猫血糖测量的高度一致性。

High concordance of blood glucose measurement in cats between a beta prototype glucometer device and a reference laboratory standard in a clinical setting.

作者信息

Walker Alex, Stewart Samuel D

机构信息

1Massachusetts Veterinary Referral Hospital, Ethos Veterinary Health, Woburn, MA.

2Ethos Veterinary Health, Woburn, MA.

出版信息

J Am Vet Med Assoc. 2024 Jan 10;262(4):1-5. doi: 10.2460/javma.23.08.0457. Print 2024 Apr 1.

Abstract

OBJECTIVE

The objective of this study was to evaluate the accuracy of a beta prototype version of a new portable blood glucose meter in feline patients.

ANIMALS

60 client-owned cats.

METHODS

In this prospective study, 3-mL blood samples were collected from each cat and analyzed in triplicate using a beta prototype device (AlphaTRAK 3 [AT3]) and by a reference lab standard immediately after collection. Accuracy of the AT3 device was determined in accordance with the International Organization of Standardization (ISO) 15197:2013 criteria, including Bland-Altman plotting and consensus error grid analysis. A Passing-Bablok regression analysis was also performed.

RESULTS

96% of feline measurements fell within the ISO accuracy threshold, and 100% of measurements fell within zones A and B of the consensus error grid, meeting the ISO accuracy requirements. There was no significant bias in the data according to the Bland-Altman analysis. Within the full range of glucose concentrations (20 to 750 mg/dL) the correlation coefficient between the AT3 and the reference lab standard was 0.99. There was no significant constant or proportional bias present in the data.

CLINICAL RELEVANCE

The AT3 device met the ISO requirements and is accurate for measurement of blood glucose concentrations in cats.

摘要

目的

本研究的目的是评估一种新型便携式血糖仪的β原型版本在猫科动物患者中的准确性。

动物

60只客户拥有的猫。

方法

在这项前瞻性研究中,从每只猫采集3毫升血样,并在采集后立即使用β原型设备(AlphaTRAK 3 [AT3])一式三份进行分析,并由参考实验室标准进行分析。根据国际标准化组织(ISO)15197:2013标准确定AT3设备的准确性,包括Bland-Altman绘图和一致性误差网格分析。还进行了Passing-Bablok回归分析。

结果

96%的猫科动物测量值落在ISO准确性阈值范围内,100%的测量值落在一致性误差网格的A区和B区内,符合ISO准确性要求。根据Bland-Altman分析,数据中没有显著偏差。在整个血糖浓度范围(20至750mg/dL)内,AT3与参考实验室标准之间的相关系数为0.99。数据中没有显著的恒定或比例偏差。

临床意义

AT3设备符合ISO要求,对猫血糖浓度的测量准确。

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