Evaluation of HemoCue 201 Performance for Hemoglobin Measurement and Anemia Detection in EDTA, Heparinized, and Capillary Blood Samples

IF 2.3 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2025-05-10 DOI:10.1111/ijlh.14495

Orakan Limpornpugdee, Sithee Sodmanee, Panatda Sohab, Chitnuphong Saengnil, Narisorn Kongruttanachok

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引用次数: 0

Abstract

Introduction

This study aimed to evaluate the analytical and diagnostic performance of the HemoCue 201 device by comparing venous EDTA, venous heparinized, and capillary blood samples.

Methods

The HemoCue 201 device was compared with an automated analyzer. Hemoglobin levels were measured from EDTA, heparinized, and capillary blood samples. Analytical performance was assessed using mean ± SD, paired t-test, intraclass correlation coefficient (ICC), and Bland–Altman plots. The CLIA 2025 criteria for acceptable error were applied to determine agreement. Diagnostic performance was determined via sensitivity, specificity, diagnostic effectiveness, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios.

Results

The results showed excellent reliability with ICC values of 1.00 for both EDTA and heparinized, and 0.97 for capillary blood. Bland–Altman plots indicated small biases for EDTA (0.08 [−0.27 to 0.42]) and heparin (0.09 [−0.40 to 0.57]), but larger negative biases for capillary blood (−0.12 [−1.21 to 0.97]). According to CLIA 2025 criteria, 98% of EDTA and 95% of heparin samples were within the ±4% cut-off, whereas only 68% of capillary samples met this criterion. Diagnostic performance demonstrated strong potential as a rapid and reliable anemia screening tool due to its high sensitivity (100%) and NPV (100%).

Conclusion

The HemoCue 201 device reliably measured hemoglobin and detected anemia in all sample types. Heparinized blood, commonly used in point-of-care blood gas tests, can effectively support hemoglobin testing, reducing the need for additional blood draws. However, capillary samples exhibited greater bias, with variability influenced by pre-analytical factors. Standardized protocol and manufacturer guidelines helped minimize analytical variation.

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HemoCue 201在EDTA、肝素化和毛细血管血液中血红蛋白测定和贫血检测的性能评价

简介：本研究旨在通过比较静脉EDTA、静脉肝素化和毛细血管血液样本来评估HemoCue 201设备的分析和诊断性能。方法：将HemoCue 201设备与全自动分析仪进行比较。从EDTA、肝素化和毛细血管血液样本中测量血红蛋白水平。分析性能采用均数±标准差、配对t检验、类内相关系数（ICC）和Bland-Altman图进行评估。采用CLIA 2025可接受误差标准来确定一致性。诊断效能通过敏感性、特异性、诊断有效性、阳性预测值（PPV）、阴性预测值（NPV）和似然比来确定。结果：EDTA和肝素化血的ICC值为1.00，毛细血管血的ICC值为0.97，结果具有良好的可靠性。Bland-Altman图显示EDTA（0.08[-0.27至0.42]）和肝素（0.09[-0.40至0.57]）的偏倚较小，但毛细血管血的偏倚较大（-0.12[-1.21至0.97]）。根据CLIA 2025标准，98%的EDTA和95%的肝素样品在±4%的截止范围内，而只有68%的毛细管样品符合这一标准。由于其高灵敏度（100%）和净现值（100%），诊断性能显示出作为快速可靠的贫血筛查工具的强大潜力。结论：HemoCue 201装置能可靠地测定血红蛋白，并能检测出所有样品类型的贫血。肝素化血通常用于即时血气检测，可有效支持血红蛋白检测，减少额外抽血的需要。然而，毛细管样品表现出更大的偏差，变异性受分析前因素的影响。标准化的方案和制造商指南有助于减少分析差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.