实验室血清钾、钠离子检测总误差与临床质量需求比较  

Comparison on the total errors of serum potassium ion and sodium ion determinations with clinical quality requirements

作　　者：王敏[1] 曹华[1] 袁维祥[1] 熊立凡[1] 

机构地区：[1]上海市长宁区同仁医院检验科,上海200050

出　　处：《检验医学》2012年第12期1007-1012,共6页Laboratory Medicine

摘　　要：目的比较实验室血清钾离子(K+)、钠离子(Na+)检测结果总误差(TE)与临床需求的差异。方法用Unity Real TimeTM质量控制软件统计9个月实验室血清K+、Na+质量控制检测结果,计算均值(x珋)、标准差(s)和变异系数(CV);并比较同组室内质量控制结果偏倚(bias)、标准差指数(SDI)、变异系数比例(CVR)和TE。通过临床问卷调查分析临床对K+、Na+检测允许总误差(TEa)的需求。评估本实验室与国内、国外K+、Na+检测质量标准、生物变异及与本院临床需求的符合性。结果 K+检测结果:平均CV 1.37%、CVR 0.68、SDI0.44、bias 1.14%、TE 3.40%;Na+检测结果:平均CV 0.94%、CVR 0.85、SDI 0.19、bias 0.17%、TE 1.72%。本院临床对K+、Na+检测平均TEa需求分别为1.63%和1.03%,对K+在高(5.0 mmol/L)、低(3.5 mmol/L)临界值时的CV需求分别为1.0%和1.5%,对Na+在高(155 mmol/L)、低(135 mmol/L)临界值时的CV需求均为0.9%。与多个国家、地区标准和生物学变异比较,本实验室K+质量控制检测质量均符合要求,而Na+质量控制检测与生物学变异有差距。与临床需求比较,K+、Na+质量控制检测均有一定差异。结论实验室在报告血清K+、Na+检测的同时,尽可能提供包括生物学变异在内的K+和Na+的合成总不确定度;并与临床沟通,让临床知晓造成K+、Na+检测TE的各个环节,达到共识,共同采取措施,不断减少误差,提高检验质量。Objective To compare the difference between the total errors （TE） in the determinations of serum potassium ion （K ＋ ） and sodium ion （Na ＋ ） determinations with clinical quality requirements. Methods The quality control results of K ＋ and Na during 9 months were analyzed statistically by Unity Real TimeTM quality control software, and the means （x）, standard deviations （s） and coefficients of variation （CV） were calculated. All the internal quality control results were compared with those of the same group in bias, standard deviation index （SDI） , coefficient of variation ratio （CVR） and TE. The clinical questionnaires related to the allowable total error （TEa） of K＋ and Na＋ were carried out and analyzed. The agreement of testing quality for K ＋ and Na ＋ was evaluated and compared with those from domestic and abroad quality standards, biological variation and the clinical requirements in our hospital. Results The averages of CV, CVR, SDI, bias and TE of K＋ and Na＋ were 1.37% ,0.68,0.44,1.14% ,3.40% and 0.94%, 0. 85 ,0.19 ,0.17% , 1.72% , respectively. The clinical requirements for average TEa of K ＋ and Na ＋ were 1.63 % and 1.03% ,respectively. At the cut-off values of K＋ （5.0 mmol/L at upper limit and 3.5mmol/L at lower limit） ,the CV were 1.0% and 1.5%, respectively. At the cut-off values of Na＋ （ 155 mmoL/L at upper limit and 135mmol/L at lower limit） ,the CV were both 0.9%. The testing quality for K＋all reached the standards of many nations and regions, and was within the range of biological variations, and so did those for Na ＋ except biological variations. In view of clinical requirements, both K ＋and Na ＋ testing qualities had some differences. Conclusions The laboratory should provide the combined uncertainty in measurement of serum K ＋ and Na ＋ while reporting the testing results. Laboratory personnels should take measures to reduce the TE and improve the quality together with clinical doctors by continuing communication.

关 键 词：钾离子 钠离子 总误差 质量要求 

分 类 号：Q592[生物学—生物化学]