Roche9180电解质分析系统检测血清锂离子的分析灵敏度和临床可报告范围建立  

Establishment of the Analytical Senstivity and Clinical Reportable Range of Roche 9180 Electrolytic Analyzer in the Detection of Serum Lithium Ion

作　　者：潘锡龙 陈扎生 何淑玲 平军娇 张嘉萱 

机构地区：[1]中山市第三人民医院检验科,广东中山528451

出　　处：《现代检验医学杂志》2013年第1期83-86,共4页Journal of Modern Laboratory Medicine

摘　　要：目的 探讨Roche 9180电解质分析系统检测血清锂离子的分析灵敏度（analytical senstivity,AS）和临床可报告范围（clinical reportable range,CRR）.方法 参照美国临床与实验室标准化协会（CLSI）EP17-A,配制一系列低浓度样本进行日间重复测定,用参数或非参数检验方法估计分析灵敏度并确定功能灵敏度（functional senstivity,FS）;参考EP6-A,配制超过厂家声明的分析测量范围（analytical measurement range,AMR）上限的高值样本与选用尽可能低的值的患者标本按比例混合成等间距的不同浓度样本进行重复测定2次,对所得数据应用SPSS19.0软件进行多项式回归分析建立AMR;配制一份高浓度样本用空白血清做不同倍数稀释,计算稀释回收率确定最大允许稀释度并结合FS建立CRR.结果 Roche 9180分析仪检测血清锂的AS为0.129～0.162 mmol/L,AMR为0.185～5.821 mmol/L,FS为0.166 mmol/L,最大允许稀释度为1∶25,CRR为0.166～145.525 mmol/L.结论 采用Roche 9180电解质分析系统检测血清锂离子具有良好的分析灵敏度和分析测量范围,完全可以满足临床治疗监测需要.通过本次研究为实验室建立了更具体更合理的报告方式.Objective To explore the analytical senstivity（AS） and clinical reportable range（CRR） of the serum lithium ion detected by Roche 9180 electrolytic analyzer. Methods According to the EP17-A document puplished by American Clinical and Laboratory Standards Institution（CLSI）,a series of low concentration samples, which were prepared previously, were detected repeatly at day interval and the results were analyzed with a parameter or a nonparametric test method to estimate the analytical senstivity. According to the EP6-A document puplished by CLSI, these samples with equal interval, proportion- al prepared with the low levels serum（L） and the high levels sample which its concentration exceed the high limit claimed by manufacture and was prepared previously, were detected twice each. The results were registered and analyzed by the SPSS19.0 statistic software with polynomial regression analysis to establish the analytical measurement range（AMR）. One sample, at high concentration level and within AMR, diluted to different dilution ratio, was detected, and the dilution recovery rate was caculated to determine the maximum allowable dilution and establish CRR by combining FS. Results The AS of the serum lithium ion detected by Roche 9180 electrolytic analyzer was 0. 129-0. 162 mmol/L, the AMR was 0. 185-5. 821 mmol/L,the FS was 0. 166 mmol/L,the maximum allowable dilution was 1 ： 25 ,and the CRR was 0. 185-145. 525 mmol/ L. Conclusion There were good AS and CRR of the serum lithium ion detected by Roche 9180 electrolytic analyzer,which can meet more needs of clinical therapy. Through this research, the more specific and more reasonable report way was determined for laboratory.

关 键 词：锂 离子选择电极 分析灵敏度 临床可报告范围 建立 

分 类 号：R446.112[医药卫生—诊断学]