Impact of hematocrit levels on the accuracy of specific blood glucose meters: A hospital-based study

IF 3.1 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Huan Nguyen Pham, Phuc Nguyen Huu Pham, Hang Thi Phan, Long Thang Cao, Hau Thi Thu Thoi, Tuyen Dang Thanh Do, Tuyet Thi Anh Truong
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引用次数: 0

Abstract

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.

Materials and Methods

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.

Results

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).

Conclusions

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.

Abstract Image

血细胞比容水平对特定血糖仪准确性的影响:一项基于医院的研究。
目的/简介:血糖仪是床边常用的仪器,但在雄旺医院(越南胡志明市)使用的大多数血糖仪都是为自我监测而设计的,可能不适合测定患者的血糖水平。在本研究中,我们旨在根据临床与实验室标准协会(CLSI)的标准验证本医院常用的六种血糖仪的性能,并调查血细胞比容对这些血糖仪准确性的影响:洪旺医院共有 135 名接受过 75 克口服葡萄糖耐量试验的孕妇同意参与这项研究。使用血糖仪一式两份测量全血葡萄糖水平,并使用 Alinity h 系列分析仪测量血细胞比容水平。在 5 分钟内,使用 Cobas c502 参考分析仪连续测量两次血浆葡萄糖水平。为了保证准确性和精确性,使用 CLSI POCT12-A3 评估了血细胞比容的影响:结果:在接受评估的六台血糖仪中,有三台合格。对于葡萄糖浓度为 5.55 mmol/L 的 CLSI 标准,Accu-Chek Inform II、Accu-Chek Performa 和 OneTouch VerioVue 分别达到了 97.31%、98.08% 和 99.62%。对于 CLSI 标准的 4.17 mmol/L,这三款产品均达到了 100%。Accu-Chek Inform II 和 Accu-Chek Performa 显示血糖水平与血细胞比容呈反相关,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 不受血细胞比容影响,斜率为 0.207(95% 置信区间-0.026 至 0.440):结论:血糖仪的测量值会受到血细胞比容的影响,其读数偏差可能不在可接受范围内。医疗机构在对患者使用血糖仪之前需要进行验证或确认。
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来源期刊
Journal of Diabetes Investigation
Journal of Diabetes Investigation ENDOCRINOLOGY & METABOLISM-
CiteScore
6.50
自引率
9.40%
发文量
218
审稿时长
6-12 weeks
期刊介绍: Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).
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