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撒哈拉以南非洲国家使用的四种主要血糖仪的准确性和精密度:一项横断面研究。

Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study.

作者信息

Choukem Simeon-Pierre, Sih Colette, Nebongo Daniel, Tientcheu Philomene, Kengne André-Pascal

机构信息

Department of Internal Medicine and Paediatrics, Faculty of Health Sciences, University of Buea, Buea, Cameroon.

Health and Human Development (2HD) Research Network, Douala, Cameroon.

出版信息

Pan Afr Med J. 2019 Mar 14;32:118. doi: 10.11604/pamj.2019.32.118.15553. eCollection 2019.

Abstract

INTRODUCTION

capillary glucose measurement using point-of-care glucometers is an essential part of diabetes care. We determined the technical accuracy, clinical accuracy and precision of commonly available glucometers against standard spectrophotometry in Cameroon.

METHODS

a sample of four glucometers was selected. In the 108 diabetic and non-diabetic participants, blood glucose values obtained by glucometers were compared to the reference laboratory method to determine their technical and clinical accuracies. Precision was determined by repeated measurements using standard solutions of different concentrations.

RESULTS

accu-Chek Active, CodeFree™, Mylife™ Pura™ and OneTouch Ultra 2 values had correlation coefficients of 0.96, 0.87, 0.97 and 0.94 respectively with reference values, and biases of 18.7%, 29.1%, 16.1% and 13.8% respectively. All glucometers had ≥ 95% of values located within the confidence limits except OneTouch Ultra2. Accu-Chek Active, CodeFree™, Mylife™ Pura™ and OneTouch Ultra 2 had 99%, 93.1%, 100% and 98.0% of values in Parke's zones A and B. The coefficients of variation of the glucometers were all below 5% at all standard concentrations, except for Accu-Chek Active for glucose concentrations at100 and 200mg/dL.

CONCLUSION

no glucometer met all the international recommendations for technical accuracy. Accu-Chek™ Active and Mylife™, Pura™ met the International Organization for Standardization 2013 recommendations for clinical accuracy based on Parke's consensus error grid analysis. All glucometers assessed except Accu-Chek Active showed a satisfactory level of precision at all concentrations of standard solutions used.

摘要

引言

使用即时血糖仪测量毛细血管血糖是糖尿病护理的重要组成部分。我们在喀麦隆针对常用血糖仪与标准分光光度法进行了技术准确性、临床准确性和精密度的测定。

方法

选取了四款血糖仪作为样本。在108名糖尿病患者和非糖尿病参与者中,将血糖仪测得的血糖值与参考实验室方法进行比较,以确定其技术和临床准确性。通过使用不同浓度的标准溶液进行重复测量来确定精密度。

结果

Accu-Chek Active、CodeFree™、Mylife™ Pura™和OneTouch Ultra 2的测量值与参考值的相关系数分别为0.96、0.87、0.97和0.94,偏差分别为18.7%、29.1%、16.1%和13.8%。除OneTouch Ultra2外,所有血糖仪的测量值≥95%位于置信区间内。Accu-Chek Active、CodeFree™、Mylife™ Pura™和OneTouch Ultra 2分别有99%、93.1%、100%和98.0%的测量值处于帕克分区A和B内。除Accu-Chek Active在葡萄糖浓度为100和200mg/dL时外,所有血糖仪在所有标准浓度下的变异系数均低于5%。

结论

没有一款血糖仪完全符合技术准确性的所有国际建议。Accu-Chek™ Active和Mylife™ Pura™根据帕克共识误差网格分析符合国际标准化组织2013年关于临床准确性的建议。除Accu-Chek Active外,所有评估的血糖仪在所用的所有标准溶液浓度下均显示出令人满意的精密度水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8400/6561013/125a34c318d4/PAMJ-32-118-g001.jpg

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