Hung Vuong Hospital, Ho Chi Minh City, Vietnam.
J Diabetes Investig. 2024 Oct;15(10):1472-1482. doi: 10.1111/jdi.14276. Epub 2024 Aug 1.
AIMS/INTRODUCTION: Blood glucose meters are commonly used at the bedside, but most of the meters used in Hung Vuong Hospital (Ho Chi Minh City, Vietnam) are built for self-monitoring and might not be suitable for determining glucose levels in patients. In this study, we aimed to validate the performance of six frequently used meters in our hospital using the Clinical & Laboratory Standards Institute (CLSI) standard, and investigate the hematocrit impact on the accuracy of these meters.
A total of 135 pregnant women who underwent a 75-g oral glucose tolerance test consented to participate in the study at Hung Vuong Hospital. Whole blood glucose levels were measured in duplicate using meters, and hematocrit levels were measured using an Alinity h-series analyzer. Within 5 min, plasma glucose levels were measured twice in a row using the Cobas c502 reference analyzer. For accuracy and precision, the hematocrit effect was assed using CLSI POCT12-A3.
Out of six evaluated meters, three meters qualified. For CLSI criterion at glucose concentration of 5.55 mmol/L, Accu-Chek Inform II, Accu-Chek Performa and OneTouch VerioVue achieved 97.31%, 98.08% and 99.62%, respectively. For CLSI criterion at 4.17 mmol/L, these three achieved 100%. Accu-Chek Inform II and Accu-Chek Performa showed an inverse correlation between glucose level and hematocrit with slopes of -0.500 (95% confidence interval -0.678 to -0.322) and -0.396 (95% confidence interval -0.569 to -0.224), whereas OneTouch VerioVue was not affected by hematocrit, with a slope of 0.207 (95% confidence interval -0.026 to 0.440).
Blood glucose meters' measurements can be affected by hematocrit, and might provide readings not within an acceptable bias. Medical organizations need to verify or validate before using on patients.
目的/引言:血糖仪常用于床边,但鸿庞医院(胡志明市,越南)使用的大多数血糖仪都是为自我监测而设计的,可能不适合用于确定患者的血糖水平。在这项研究中,我们旨在使用临床和实验室标准协会(CLSI)标准验证我院六款常用血糖仪的性能,并研究红细胞比容对这些血糖仪准确性的影响。
共有 135 名接受 75g 口服葡萄糖耐量试验的孕妇同意在鸿庞医院参与研究。使用血糖仪重复测量两份全血血糖水平,并使用 Alinity h 系列分析仪测量红细胞比容水平。在 5 分钟内,使用 Cobas c502 参考分析仪连续两次测量血浆血糖水平。为了评估准确性和精密度,使用 CLSI POCT12-A3 评估红细胞比容的影响。
在评估的六款血糖仪中,有三款合格。对于 5.55mmol/L 葡萄糖浓度的 CLSI 标准,Accu-Chek Inform II、Accu-Chek Performa 和 OneTouch VerioVue 的符合率分别为 97.31%、98.08%和 99.62%。对于 4.17mmol/L 的 CLSI 标准,这三款血糖仪的符合率均为 100%。Accu-Chek Inform II 和 Accu-Chek Performa 显示血糖水平与红细胞比容之间呈负相关,斜率分别为-0.500(95%置信区间-0.678 至-0.322)和-0.396(95%置信区间-0.569 至-0.224),而 OneTouch VerioVue 不受红细胞比容影响,斜率为 0.207(95%置信区间-0.026 至 0.440)。
血糖仪的测量结果可能会受到红细胞比容的影响,并且可能提供不在可接受偏差范围内的读数。医疗机构在用于患者之前需要进行验证或确认。