实验室血清钾、钠离子检测总误差与临床质量需求比较

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()、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、SDI 0.44、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 Time 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 ( CAR ) 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.