评价一种新的自动化常规检测方法在疑似钙代谢疾病患者血清校正离子钙(at pH 7.4)中的应用。

Evaluation of a New Automated Routine Measurement for Serum Adjusted Ionized Calcium (at pH 7.4) in Patients Suspected of Calcium Metabolic Disease.

机构信息

Department of Clinical Biochemistry, North Zealand Hospital Hilleroed, University of Copenhagen, Copenhagen, Denmark.

出版信息

J Appl Lab Med. 2020 Jul 1;5(4):704-715. doi: 10.1093/jalm/jfaa006.

DOI:10.1093/jalm/jfaa006

PMID:32603436

Abstract

BACKGROUND

Total calcium is a less accurate test in predicting ionized calcium (Ca2+) in patients suspected of calcium metabolic disease. Nevertheless, total calcium continues to be used as routine measurement instead of adjusted Ca2+ (at pH 7.4). In the current study we evaluate a new multichannel instrument, the ISE Module E1200 for adjusted Ca2+ (at pH 7.4), containing three different ion-selective electrode (ISE) units.

METHODS

Serum from 1350 patients was compared to the ABL835 flex and KoneLab. Total calcium was also evaluated on the Dimension Vista 1500 system. Correlations between instruments were assessed by Deming regression and degree of agreement by Cohen's kappa (κ).

RESULTS

Analytical imprecisions for the three ISE units for adjusted Ca2+ (at pH 7.4) was between 0.36% and 2.52%, and for pH between 0.32% and 3.24%. Results were comparable for each ISE unit (r = 0.797-0.917; all P < 0.0001) and in high-throughput settings (r = 0.871; P < 0.0001). The degree of agreement between instruments was moderate to good (κ = 0.52-0.77). In contrast, there was a very poor agreement (κ = -0.14) for total calcium with discrepancy in 53.4% of the samples.

CONCLUSIONS

The new ISE Module E1200 is comparable with the ABL835 flex and KoneLab 30i and therefore may be used for routine analysis of serum adjusted Ca2+ (at pH 7.4). The measured adjusted Ca2+ (at pH 7.4) was less comparable with very poor agreement to total calcium measured on the Dimension Vista 1500 system.

摘要

背景

总钙在预测疑似钙代谢疾病患者的离子钙（Ca2+）方面是一项不够准确的检测。尽管如此，总钙仍被用作常规测量，而不是调整后的 Ca2+（在 pH 7.4 时）。在本研究中，我们评估了一种新的多通道仪器，ISE Module E1200，用于调整后的 Ca2+（在 pH 7.4 时），包含三个不同的离子选择性电极（ISE）单元。

方法

比较了 1350 例患者的血清与 ABL835 flex 和 KoneLab。在 Dimension Vista 1500 系统上也评估了总钙。通过 Deming 回归评估仪器间的相关性，通过 Cohen's kappa（κ）评估一致性程度。

结果

三个 ISE 单元用于调整后的 Ca2+（在 pH 7.4 时）的分析精密度在 0.36%至 2.52%之间，pH 在 0.32%至 3.24%之间。每个 ISE 单元的结果均具有可比性（r=0.797-0.917；均 P<0.0001），并且在高通量设置下也具有可比性（r=0.871；P<0.0001）。仪器间的一致性程度为中度至高度（κ=0.52-0.77）。相比之下，总钙的一致性非常差（κ=-0.14），有 53.4%的样本存在差异。

结论

新的 ISE Module E1200 与 ABL835 flex 和 KoneLab 30i 具有可比性，因此可用于常规分析血清调整后的 Ca2+（在 pH 7.4 时）。测量的调整后的 Ca2+（在 pH 7.4 时）与 Dimension Vista 1500 系统上测量的总钙的相关性较差，一致性非常差。