基于IFCC参考测量程序实现常规检测系统量值溯源的可行性探索

doi:10.3969/j.issn.1673-8640.2015.10.018

摘要/Abstract

摘要： 目的

探讨基于国际临床化学与检验医学联合会(IFCC)参考测量程序对常规检测系统实现量值溯源的可行性分析。

方法

以乳酸脱氢酶(LDH)为例,采用IFCC参考测量程序和常规检测系统(以下简称A法)同时测定20份不同浓度冷冻人混合血清样本。按《临床检验质量管理技术基础》中判定依据和偏移图分析法进行评价常规检测系统测量结果的正确度,对存在系统偏移的常规方法通过回归分析进行厂家校准品认定值校正,并测定20份不同浓度的新鲜单人份血清验证校正后该方法(以下简称B法)测量结果的正确性。

结果

A法与IFCC参考测量程序测定结果的直线回归方程为Y=1.092X-4.529,平均偏移为7.24%,B法校准品校正值为174 U/L。经验证B法与IFCC参考测量程序测定结果的直线回归方程为Y=0.988X-0.470,平均偏移降为-1.37%。

结论

A法测量结果明显偏高于参考测量程序测量结果,经校正建立的B法与参考测量程序测定结果一致。

关键词: 乳酸脱氢酶, 常规方法, 参考测量程序

Abstract: Objective

To investigate the feasibility for metrological traceability of conventional determination system based on the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)reference measurement procedure.

Methods

The 20 frozen serum samples with different concentrations were determined for lactate dehydrogenase(LDH)according to IFCC reference measurement procedure and routine method (as A method). The accuracy was evaluated according to the guideline of the Basic Quality Management Practice in Clinical Laboratory and the offset graph graphical-analysis. If the routine method existed bias, the calibration value was corrected by regression analysis. The fresh single serum samples of LDH were determined simultaneously by IFCC reference measurement procedure and routine method (as B method) in order to verify the accuracy measured by A method.

Results

The regression equation with A method and IFCC reference measurement procedure was Y=1.092X-4.529, and the average bias value was 7.24%. B method calibrators' correction value was 174 U/L. The regression equation with B method and IFCC reference measurement procedure was Y=0.988X-0.470, and the average bias value was -1.37%.

Conclusions

The results of A method are significantly higher than those of IFCC reference measurement procedure, and the results of B method established through amendments are consistent with those of IFCC reference measurement procedure.

Key words: Lactate dehydrogenase, Routine method, Reference measurement procedure

中图分类号:

Q554

邓拥军, 石英, 周俊, 吴立山, 沈敏. 基于IFCC参考测量程序实现常规检测系统量值溯源的可行性探索[J]. 检验医学, 2015, 30(10): 1039-1043.

DENG Yongjun, SHI Ying, ZHOU Jun, WU Lishan, SHEN Min. Investigation on the feasibility for metrological traceability of conventional determination system based on IFCC reference measurement procedure[J]. Laboratory Medicine, 2015, 30(10): 1039-1043.

图/表 6

表1 IFCC参考测量程序性能

样本	检测次数	均值 (U/L)	认定值±不确定度 (U/L,k=2)	结果
样本	检测次数	均值 (U/L)	认定值±不确定度 (U/L,k=2)	偏移(%)	CV(%)
ERM-AD453	3	505.5	502±7	0.70	0.52
C.f.a.s	10	262.4	259.8	1.00	0.43

图1 A法与IFCC参考测量程序测定结果比较

图2 B法与IFCC参考测量程序测定结果比较

图3 A法与IFCC参考测定程序测定结果的偏移

图4 B法与IFCC参考测定程序测定结果的偏移

图5 B法与IFCC参考测量程序校验结果比较及偏移图

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