血清丙氨酸氨基转移酶检测的临床可报告范围的建立及评价

Establishment and evaluation on the clinical reportable rang of serum alanine aminotransferase

目的分析德赛诊断试剂采用Beckman Dxc800生化仪检测血清丙氨酸氨基转移酶（ALT）的灵敏度（FS）、最大允许稀释度（MAD）、分析测量范围（AMR）等,并建立ALT临床可报告范围（CRR）,为临床提供可靠检测结果。方法参照美国临床和试验室标准化协会（CLSI）EP6-A文件,选用覆盖厂家声明AMR的高、低值患者混合标本配制系列等间距不同浓度标本进行ALT重复测定2次,应用SPSS19.0统计软件进行AMR多项式回归分析;选用5份较低浓度标本进行日间重复测定ALT,以相应的变异系数与检测均值关系确定FS;选用3份高浓度ALT标本用生理盐水进行不同倍数稀释后再测定,计算回收率,确定MAD,并结合FS建立CRR。结果应用德赛诊断试剂采用Beckman Dxc800生化仪检测血清ALT的AMR为5.50-847.50U/L,FS为3.698U/L,MAD为1∶8,CRR为3.698-6 780.000U/L。结论应用德赛诊断试剂采用Beckman Dxc800生化仪进行血清ALT检测的AMR较厂家声明的宽;所建立的CRR可满足临床常规需要。

Objective To explore the functional sensitivity, maximum allowable dilution, analytical measurement range and clinical reportable rang of the serum alanine aminotransferase （ALT） detected by Beckman Dxc800 automatic analyzer with the DiaSys diagnostic biochemistry reagent kits. Methods According to the EP6-A document published in 2004 by American Clinical and La- boratory Standards Institution（CLSI）,these samples with equal interval, proportional prepared with the low levels serum and the high levels serum and their concentration exceeding the range claimed by manufacture, were detected twice each. The results were registered and analyzed by the SPSS19.0 statistic software with polynomial regression analysis to determine the analytical measurement range. Five samples at the low concentration,which were prepared previously, were detected repeat at day interval. And the functional sensitivity was determined with combining the coefficient of variation and the average value. Three samples, diluted to different dilution ratio with physiological saline, were detected. The dilution recovery rate, which was required in the range of 90% -110%, was calculated to establish the clinical reportable rang by combining the Functional Sensitivity. Results The analytical measurement range of the serum ALT detected by Beckman DxcS00 analyzer was 5.50-847.50 U/L,the functional sensitivity was 3. 698 U/L,the maximum allowable dilution was 1： 8 and the clinical reportable rang was 3. 698-6 780.0 U/L. Conclusion The analytical measurement range of the serum ALT detected by Beckman Dxc800 analyzer with the DiaSys diagnostic biochemistry rea- gent kits, was wider than that of being claimed by manufacture,the clinical reportable rang could meet the need of clinic.