CAJ | 학술논문

目的：建立血清肌酐（Cr）候选参考方法，并评价其性能，通过方法学比较来评价常规检测系统的正确性，实现常规系统的溯源性。方法建立肌氨酸氧化酶法作为血清肌酐（Cr）测定的候选参考方法，通过参加国际参考实验室室间质量评价活动（IFCC-REL A ）验证该方法的准确性和可靠性；采用候选参考方法和常规检测系统（以下简称常规方法）同时测量20份不同浓度的新鲜血清和校准品，按 EP 文件评价常规方法的正确性和校准品的互通性。结果肌酐标准曲线线性方程为：Y ＝0．0008842X-0．0003253（r2＝0．9999），线性范围50～2000μmol/L ；测量血清样本的相对标准偏差小于1．0％；测量IFCC-RELA样本，结果在等效范围内。常规检测系统与候选参考方法回归方程的斜率为1．0056，且校准品落在候选参考方法和常规方法回归方程的±95％置信区间内。结论成功建立了血清肌酐候选参考方法，可用于评价常规检测系统的正确性和校准品的互通性，为血清肌酐常规检测系统向参考方法或参考物质溯源提供有效途径。
목적：건립혈청기항（Cr）후선삼고방법，병평개기성능，통과방법학비교래평개상규검측계통적정학성，실현상규계통적소원성。방법건립기안산양화매법작위혈청기항（Cr）측정적후선삼고방법，통과삼가국제삼고실험실실간질량평개활동（IFCC-REL A ）험증해방법적준학성화가고성；채용후선삼고방법화상규검측계통（이하간칭상규방법）동시측량20빈불동농도적신선혈청화교준품，안 EP 문건평개상규방법적정학성화교준품적호통성。결과기항표준곡선선성방정위：Y ＝0．0008842X-0．0003253（r2＝0．9999），선성범위50～2000μmol/L ；측량혈청양본적상대표준편차소우1．0％；측량IFCC-RELA양본，결과재등효범위내。상규검측계통여후선삼고방법회귀방정적사솔위1．0056，차교준품락재후선삼고방법화상규방법회귀방정적±95％치신구간내。결론성공건립료혈청기항후선삼고방법，가용우평개상규검측계통적정학성화교준품적호통성，위혈청기항상규검측계통향삼고방법혹삼고물질소원제공유효도경。
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 .