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西格玛指标的应用以及两种生化分析仪与一台血气分析仪在电解质测定方面的性能比较

Application of Sigma Metrics and Performance Comparison Between Two Biochemistry Analyser and a Blood Gas Analyser for the Determination of Electrolytes.

作者信息

Ustundag-Budak Yasemin, Huysal Kagan

机构信息

Department of Clinical Biochemistry, Saglik Bilimleri University, Bursa Yuksek Ihtisas Training and Research Hospital , Bursa, Turkey .

Department of Clinical Biochemistry, Saglik Bilimleri University , Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey .

出版信息

J Clin Diagn Res. 2017 Feb;11(2):BC06-BC09. doi: 10.7860/JCDR/2017/23486.9259. Epub 2017 Feb 1.

DOI:10.7860/JCDR/2017/23486.9259
PMID:28384850
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5376911/
Abstract

INTRODUCTION

Electrolytes have a narrow range of biological variation and small changes are clinically significant. It is important to select the best method for clinical decision making and patient monitoring in the emergency room. The sigma metrics model provides an objective method to evaluate the performance of a method.

AIM

To calculate sigma metrics for electrolytes measured with one arterial blood gas analyser including two auto-analysers that use different technologies. To identify the best approach for electrolyte monitoring in an emergency setting and the context of routine emergency room workflow.

MATERIALS AND METHODS

The Coefficient of Variation (CV) was determined from Internal Quality Control (IQC). Data was measured from July 2015 to January 2016 for all three analysers. The records of KBUD external quality data (Association of Clinical Biochemists, Istanbul, Turkey) for both Mindray BS-2000M analyser (Mindray, Shenzhen, China) and Architect C16000 (Abbott Diagnostics, Abbott Park, IL) and MLE clinical laboratory evaluation program (Washington, DC, USA) for Radiometer ABL 700 (Radiometer Trading, Copenhagen, Denmark) during the study period were used to determine the bias.

RESULTS

The calculated average sigma values for sodium (-1.1), potassium (3.3), and chloride (0.06) were with the Radiometer ABL700. All calculated sigma values were better than the auto-analysers.

CONCLUSION

The sigma values obtained from all analysers suggest that running more controls and increasing the calibration frequency for electrolytes is necessary for quality assurance.

摘要

引言

电解质的生物学变异范围狭窄,微小变化在临床上具有重要意义。在急诊室选择最佳方法用于临床决策和患者监测非常重要。西格玛指标模型提供了一种评估方法性能的客观方法。

目的

计算使用一台动脉血气分析仪(包括两台采用不同技术的自动分析仪)测定电解质的西格玛指标。确定在紧急情况下以及常规急诊室工作流程背景下进行电解质监测的最佳方法。

材料与方法

变异系数(CV)由内部质量控制(IQC)确定。对所有三台分析仪在2015年7月至2016年1月期间进行数据测量。使用迈瑞BS-2000M分析仪(中国深圳迈瑞)和Architect C16000(美国伊利诺伊州雅培公园雅培诊断公司)的KBUD外部质量数据记录,以及在研究期间丹麦哥本哈根Radiometer Trading公司的Radiometer ABL 700的MLE临床实验室评估程序(美国华盛顿特区)来确定偏差。

结果

使用Radiometer ABL700测得的钠(-1.1)、钾(3.3)和氯(0.06)的计算平均西格玛值。所有计算出的西格玛值均优于自动分析仪。

结论

从所有分析仪获得的西格玛值表明,为保证质量,有必要增加电解质的质控次数并提高校准频率。

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