Performance evaluation of the glycated hemoglobin A1c analyzer for point-of-care testing compared with laboratory-based devices: a multicenter validation study.

IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Yiwen Zhou, Fan Yang, Mi Zhou, Baishen Pan, Beili Wang, Wei Guo, Wenqi Shao, Jing Zhu
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引用次数: 0

Abstract

In this dual-center study, we assessed the BioHermes A1C EXP M13 system for point-of-care (POC) HbA1c testing against two NGSP-certified HPLC instruments, the Bio-Rad D100 and Tosoh G8. Analyzing 605 samples, we evaluated the A1C EXP's reproducibility, sensitivity, specificity and impact of anemia on HbA1c measurements. The device showed excellent reproducibility with CVs under 2.4% and high sensitivity and specificity for diabetes diagnosis-98.1% and 96.8% against D100, and 97.1% and 96.7% against G8. Passing-Bablok regression confirmed a close correlation between A1C EXP and the HPLC instruments, with equations y = 0.10625 + 0.9688x (D100) and y = 0.0000 + 0.1000x (G8), and Bland-Altman plots indicated mean relative differences of -1.4% (D100) and -0.4% (G8). However, in anemic samples, A1C EXP showed a negative bias compared to HPLC devices, suggesting that anemia may affect the accuracy of HbA1c results. The study indicates that A1C EXP is a reliable POC alternative to laboratory assays, albeit with considerations for anemic patients.

用于床旁检测的糖化血红蛋白 A1c 分析仪与实验室设备的性能评估:一项多中心验证研究。
在这项双中心研究中,我们对用于床旁 (POC) HbA1c 检测的 BioHermes A1C EXP M13 系统与两台通过 NGSP 认证的 HPLC 仪器(Bio-Rad D100 和 Tosoh G8)进行了对比评估。通过分析 605 份样本,我们评估了 A1C EXP 的重现性、灵敏度、特异性以及贫血对 HbA1c 测量的影响。该仪器的重现性极佳,CV 值低于 2.4%,糖尿病诊断的灵敏度和特异性也很高,与 D100 相比分别为 98.1%和 96.8%,与 G8 相比分别为 97.1%和 96.7%。Passing-Bablok 回归证实了 A1C EXP 与 HPLC 仪器之间的密切相关性,方程为 y = 0.10625 + 0.9688x (D100)和 y = 0.0000 + 0.1000x (G8),Bland-Altman 图显示平均相对差异为-1.4% (D100)和-0.4% (G8)。然而,在贫血样本中,A1C EXP 与 HPLC 设备相比显示出负偏差,这表明贫血可能会影响 HbA1c 结果的准确性。这项研究表明,A1C EXP 是一种可靠的 POC 方法,可以替代实验室检测,但需要考虑贫血患者的情况。
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来源期刊
CiteScore
3.50
自引率
4.80%
发文量
85
审稿时长
4-8 weeks
期刊介绍: The Scandinavian Journal of Clinical and Laboratory Investigation is an international scientific journal covering clinically oriented biochemical and physiological research. Since the launch of the journal in 1949, it has been a forum for international laboratory medicine, closely related to, and edited by, The Scandinavian Society for Clinical Chemistry. The journal contains peer-reviewed articles, editorials, invited reviews, and short technical notes, as well as several supplements each year. Supplements consist of monographs, and symposium and congress reports covering subjects within clinical chemistry and clinical physiology.
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