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Updated: May 12, 2025
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Evaluation of HemoCue 201 Performance for Hemoglobin Measurement and Anemia Detection in EDTA, Heparinized, and
Orakan Limpornpugdee1, Sithee Sodmanee2, Panatda Sohab2
1Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
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.
