Avcioglu Gamze, Nural Cemil, Yilmaz Fatma Meriç, Baran Pervin, Erel Özcan, Yilmaz Gülsen
Department of Medical Biochemistry, Ankara Yıldırım Beyazıt University Faculty of Medicine, Ankara, Turkey.
Department of Clinical Biochemistry, Ankara Atatürk Training and Research Hospital, Ankara, Turkey.
J Clin Lab Anal. 2018 Mar;32(3). doi: 10.1002/jcla.22309. Epub 2017 Aug 23.
Rapid and practical point-of-care testing (POCT) devices become more popular, especially in blood donation centers for determining predonation hemoglobin (Hb) concentrations. The purpose of this study was to evaluate accordance between the POCT methods and the venous method as the reference to Hb screening.
A total of 353 subjects with no known significant health problems were included in the study. Hb screening was performed by two different POCT methods, a noninvasive method (Haemospect, MBR, Germany) and an invasive method (HemoControl, EKF Diagnostic, Germany), and a venous method as the reference (Sysmex XE-2100, Sysmex Europe, Germany). The obtained results were compared.
The sensitivity and the specificity values of the invasive POCT method (83.3%, 87.9%) were higher than the noninvasive POCT method (66.7%, 77.1%). The Bland-Altman analysis was evaluated for both sexes and the bias of the noninvasive POCT method of the males (-0.97 g/dL) was higher than the bias of the invasive POCT method of the males (-0.07 g/dL). We found a better correlation between the invasive POCT method (r = .908) compared with the venous method than the noninvasive POCT method (r = .634).
Predonation Hb measurements must be performed with accurate, precise, and practical methods. Although the noninvasive POCT method was practical and painless, it had lower levels of specificity and sensitivity, and more false deferral and pass rates than the invasive POCT method. The POCT methods agreeable to the venous method as the reference might be suitable for Hb screening especially for centers of excessive numbers of blood donation.
快速实用的即时检验（POCT）设备越来越受欢迎，尤其是在献血中心用于测定献血前血红蛋白（Hb）浓度。本研究的目的是评估POCT方法与作为Hb筛查参考的静脉血检测方法之间的一致性。
本研究共纳入353名无已知重大健康问题的受试者。采用两种不同的POCT方法进行Hb筛查，一种是非侵入性方法（Haemospect，德国MBR公司）和一种侵入性方法（HemoControl，德国EKF诊断公司），并以静脉血检测方法（Sysmex XE - 2100，德国Sysmex欧洲公司）作为参考。对获得的结果进行比较。
侵入性POCT方法的敏感性和特异性值（83.3%，87.9%）高于非侵入性POCT方法（66.7%，77.1%）。对男女分别进行了Bland - Altman分析，男性非侵入性POCT方法的偏差（-0.97 g/dL）高于男性侵入性POCT方法的偏差（-0.07 g/dL）。我们发现，与静脉血检测方法相比，侵入性POCT方法（r = 0.908）的相关性优于非侵入性POCT方法（r = 0.634）。
献血前Hb测量必须采用准确、精确且实用的方法。虽然非侵入性POCT方法实用且无痛，但与侵入性POCT方法相比，其特异性和敏感性较低，假延期和通过率更高。与作为参考的静脉血检测方法一致的POCT方法可能适用于Hb筛查，特别是对于献血量过多的中心。
