Development of a candidate reference method for the determination of serum creatinine and application for accuracy assessment of conventional detection systems / 国际检验医学杂志

ABSTRACT

Objective To develop a candidate reference method for the determination of serum creatinine and to evaluate the ac-curacy of conventional detection systems though method comparison to achieve traceability .Methods The candidate reference method was established according to the sarcosine oxidase and the accuracy and reliability of the method was verified through par-ticipation in international reference laboratories EQA activities (IFCC-RELA) .20 fresh single human serum samples with different concentration and calibrator were simultaneously measured by using conventional detection system and candidate reference method . Results The calibration curve for serum creatinine was linear in the concentration range from 50-2 000 μmol/L with a correlation coefficient of 0 .999 9 under the optimum experimental conditions (the linear equation was Y=0 .000 884 2X-0 .000 325 3) and the imprecision was less than 1 .0% .The proposed method has been applied to the determination of RELA samples with satisfactory re-sults .The measured results with conventional detection systems were consistent with candidate reference method ,and the slope of the regression equation was 1 .005 6 .Conclusion The candidate reference method of serum creatinine is successfully established and which can be used for traceability and standardization .It may provide an effective way for conventional detection system traceable to the reference method or reference material .