血清总胆红素参考方法的建立及其不确定度评估

摘要

目的：建立血清总胆红素（T-BIL）参考方法，评价其性能，并评估其测量结果不确定度。方法根据国际医学检验溯源联合委员会（JCTLM）公布的相关文献建立参考实验室内部的血清总胆红素参考方法，对方法的线性、精密度和准确度进行评估，测量结果不确定度参照GUM文件进行评估。结果总胆红素标准曲线线性方程为：Y＝0．00750X-0．00308，R2＝0．9999，线性范围0～200 mg/L；测量血清样本的相对标准偏差（犆犞）小于1．0％；测量IFCC-RELA样本，结果在等效范围内，相对标准不确定度[urep（c）]小于2．0％。结论成功建立了血清总胆红素参考方法，可用于血清总胆红素项目的量值溯源和标准化，为血清总胆红素常规检测系统向参考方法/参考物质溯源提供有效途径。%Objective To establish the reference methods of serum total bilirubin(T-Bil),and evaluate its analytical performance and uncertainty for measurement results.Methods According to the relative literatures of JCTLM,the reference method was estab-lished.The linearity,precision,and accuracy of the methods were evaluated and the uncertainty of the result was evaluated according to the GUM 2000.Results The calibration curve for total bilirubin was linear in the concentration range from 0-200 mg/L with a correlation coefficient of 0.9999 under the optimum experimental conditions(the linear equation was Y= 0.007 50 X-0.003 08,R2= 0 .9 9 9 9 )and the imprecision was less than 1 .0%.The results of the method were located within the limits of equivalence in the IFCC ring trail for reference laboratories and the relative expanded uncertainty was less than 2 .0%.Conclusion The reference method of total bilirubin was successfully established and can be used for traceability and standardization.It may provide an effective way for routine testing of total bilirubin traceable to the reference method/reference material.