[1]陆雅春,宁 芬,李婷婷,等.ALT,AST,GGT和LDH检测JSCC法变更IFCC法性能验证[J].现代检验医学杂志,2015,30(02):111-113.[doi:10.3969/j.issn.1671-7414.2015.02.034]
　LU Ya-chun,NING Fen,LI Ting-ting,et al.Evaluation of the Method Change from JSCC to IFCC for ALT,AST,GGT and LDH Detection[J].Journal of Modern Laboratory Medicine,2015,30(02):111-113.[doi:10.3969/j.issn.1671-7414.2015.02.034]
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ALT,AST,GGT和LDH检测JSCC法变更IFCC法性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年02期
页码:
111-113
栏目:
研究简报·实验技术
出版日期:
2015-03-20

文章信息/Info

Title:
Evaluation of the Method Change from JSCC to IFCC for ALT,AST,GGT and LDH Detection
作者:
陆雅春; 宁 芬; 李婷婷; 黄开泉
安徽中医药大学第一附属医院检验中心,合肥 230031
Author(s):
LU Ya-chun; NING Fen; LI Ting-ting; HUANG Kai-quan
Clinical Laboratory Center, the First Affiliated Hospital of Anhui Chinese Medicine University,Hefei230031,China
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
DOI:
10.3969/j.issn.1671-7414.2015.02.034
文献标志码:
A
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。
Abstract:
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 ofthe 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 values Y=aX+b,in which a was within the range of 0.97～1.03,b was within an acceptable range.The reportable range verificationresults 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 R2 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.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:陆雅春(1982-),女,硕士,初级检验师,主要从事临床生物化学检验诊断,Tel:18655136100,E-mail:luyachun.happy@163.com。
更新日期/Last Update: 2015-03-20