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使用日本血清参考物质对商用离子钙分析仪进行准确性评估及血细胞比容影响研究

Accuracy evaluation and hematocrit effect of commercial ionized calcium analyzers using Japanese serum reference material.

作者信息

Kuwa K, Tani W, Hayashi K, Umemoto M

机构信息

Department of Clinical Chemistry, College of Medical Technology and Nursing, University of Tsukuba, Ibaraki, Japan.

出版信息

Scand J Clin Lab Invest Suppl. 1996;224:173-7. doi: 10.3109/00365519609088637.

DOI:10.3109/00365519609088637
PMID:8865433
Abstract

The serum reference material for concentration measurement of ionized calcium in blood has been established by our research group in Japan. The reference method used is the reference standard cell (RSC:IFCC/WGSE, Covington-Umemoto Cell) system. Here we present the results of the evaluation of accuracy using the serum reference material and the hematocrit effect of the nine commercial ionized calcium analyzers being used in routine measurements by Japanese round robin test program. The ionized calcium concentration and pH of two concentration levels of the reference material were analyzed in triplicate measurements according to the standard procedures designated by manufacturers. The effect of hematocrit in ionized calcium concentration measurement was tested using plasma and whole blood with hematocrit values of 35%, 50% and 65%, respectively. The range of bias of ionized calcium values were -0.14 approximately +0.09 mmol/L, -0.12 approximately +0.09 mmol/L for ionized calcium, respectively. The effect of hematocrit in ionized calcium concentration measurement was strongly observed in GEM Premier, CAI-101 and GASTAT-2 analyzers.

摘要

我们日本的研究小组已建立了用于血液中离子钙浓度测量的血清参考物质。所采用的参考方法是参考标准电池(RSC:IFCC/WGSE,科温顿-梅本电池)系统。在此,我们展示了使用该血清参考物质进行准确度评估的结果,以及通过日本循环检验计划对九种用于常规测量的商用离子钙分析仪的血细胞比容效应的评估结果。按照制造商指定的标准程序,对参考物质两个浓度水平的离子钙浓度和pH值进行了三次重复测量。分别使用血细胞比容值为35%、50%和65%的血浆和全血测试了血细胞比容对离子钙浓度测量的影响。离子钙值的偏差范围分别为离子钙约-0.14至+0.09 mmol/L、约-0.12至+0.09 mmol/L。在GEM Premier、CAI-101和GASTAT-2分析仪中强烈观察到血细胞比容对离子钙浓度测量的影响。

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