Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.
Scand J Clin Lab Invest. 2009;69(8):817-21. doi: 10.3109/00365510903329651.
The aim of this study was to evaluate the analytical performance of a new portable haemoglobinometer, Hemo_Control (EKF-diagnostic, GmbH, Germany), which measures haemoglobin concentration in venous and capillary samples.
The within series and between series imprecision of the Hemo_Control instrument were calculated after measuring the concentration of venous samples under standardized conditions; by experienced laboratory technicians in a hospital laboratory, and venous and capillary samples under conditions similar to where the instrument is intended for use; by personnel at two primary health care centres. The bias of the Hemo_Control instrument was calculated as the difference between its results and results obtained with a Coulter LH 750 instrument traceable to the ICSH reference method.
The uncertainty of the Hemo_Control instrument for venous samples was lower than the quality goal of +/- 5% considered acceptable for patient care. High within series imprecision (5.5%) was observed for measurements of capillary blood samples in one of the primary care centres, whereas adequate analytical performance was obtained at the other centre. The Hemo_Control instrument showed negligible bias of +0.8 g/L for both venous and capillary samples in primary health care.
The observed uncertainty indicates that Hemo_Control is appropriate for near patient testing using venous samples. Capillary samples may be used if sampling skills are adequate.
本研究旨在评估一种新的便携式血红蛋白计 Hemo_Control（EKF-diagnostic GmbH，德国）的分析性能，该仪器可测量静脉和毛细血管样本中的血红蛋白浓度。
在标准化条件下测量静脉样本的浓度后，计算 Hemo_Control 仪器的批内和批间精密度；由医院实验室的经验丰富的实验室技术人员，以及类似于仪器预期使用的条件下的静脉和毛细血管样本进行测量；由两个初级保健中心的人员进行测量。Hemo_Control 仪器的偏差计算为其结果与可溯源至 ICSH 参考方法的 Coulter LH 750 仪器结果之间的差异。
对于静脉样本，Hemo_Control 仪器的不确定性低于考虑用于患者护理的可接受的 +/- 5%质量目标。在其中一个初级保健中心，对毛细血管血样的测量表现出较高的批内精密度（5.5%），而在另一个中心则获得了足够的分析性能。在初级保健中，Hemo_Control 仪器对静脉和毛细血管样本的偏差可忽略不计，为+0.8 g/L。
观察到的不确定性表明，Hemo_Control 适用于使用静脉样本进行床边检测。如果采样技能足够，也可以使用毛细血管样本。
