Investigation on the feasibility for metrological traceability of conventional determination system based on IFCC reference measurement procedure

doi:10.3969/j.issn.1673-8640.2015.10.018

Abstract

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

CLC Number:

Q554

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.

Figures/Tables 6

References 14

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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

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

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