ALT，AST，GGT 和 LDH 检测JSCC 法变更 IFCC 法性能验证  

Evaluation of the Method Change from JSCC to IFCC for ALT,AST,GGT and LDH Detection

作　　者：陆雅春[1] 宁芬[1] 李婷婷[1] 黄开泉[1] 

机构地区：[1]安徽中医药大学第一附属医院检验中心,合肥230031

出　　处：《现代检验医学杂志》2015年第2期111-114,共4页Journal of Modern Laboratory Medicine

摘　　要：目的：对 ALT，AST，GGT 和 LDH 检测方法由 JSCC 法变更为 IFCC 法进行性能验证。方法对新方法进行正确度、精密度验证，线性范围评价，临床可报告范围评价，并与原方法进行方法学比对试验。结果 ALT，AST，GGT 和LDH 正确度偏倚＜1／2允许总误差；批内精密度 CV＜1／4允许总误差，日间精密度 CV＜1／3允许总误差；线性范围评价所得的回归方程Y ＝aX ＋b，a 在0.97～1.03范围内，b 在可接受范围内；可报告范围验证结果显示，标本经不同比例稀释后，实测值／预期值均在90％～110％，说明在一定范围内的标本稀释检测结果可靠。与原方法进行的回归比对所得回归方程相关系数均接近于1。结论ALT，AST，GGT 和 LDH 检测的新方法分析性能满足临床检测需求。Abstact：Objective To evaluate the method change from JSCC to IFCC for ALT,AST,GGT and LDH Detection.Methods The accuracy,precision,linearity and reportable range of the new detection method for ALT,AST,GGT and LDH,and the comparison analysis on the two different reagents were evaluated.Results All the accuracy bias of the testing items were within the required 1/2TEa,and all the within-run precision and between run precision were within the required 1/4TEa and 1/3TEa respectively.The linear verification results got the regression equation of the theoretical and measured valuesY =aX＋b,in which a was within the range of 0.97-1.03,b was within an acceptable range.The reportable range verification results showed that after the samples being diluted by different proportions,the measured/expected values were all between 90% and 110%,indicating that within a certain range of sample dilution the test esults were reliable.The comparison results showed the R 2 closed to 1.Conclusion The evaluation of the method change for ALT,AST,GGT and LDH detection met the basic requirements of the experiments in clinical diagnosis.

关 键 词：IFCC JSCC 性能验证 精密度 线性范围 可报告范围 回归分析 

分 类 号：R446.112[医药卫生—诊断学]