Objective To establish the reference methods of serum total proteins(TP) and evaluate its analytical performance and measurement uncertainty. Methods The reference method was established according to relative documents of JCTLM. The measurement condition was verify and optimized,and the sensitivity, precision, linearity, and accuracy of the methods were evalua-ted. The uncertainty of the result was evaluated according to GUM. Results The instruments including spectrophotometer,analyti-cal balance, pipettes were verified and the reagents meet method requirements. The reaction condition was optimized to temperature of 37 ℃ and time of 10 min. The sensitivity of the TP reference method was 0. 005 82, and intra-Lab imprecision was less thanrn0. 7%,the linear range was 0 - 120 g/L. There was no significant differences(P＞0. 05) between two Labs. The results of the method were located within the limits of equivalence in the IFCC ring trail for reference laboratories, and the uncertainty wasrn1. 8%. Conclusion The reference method of total proteins was successfully established. The performance of the method met the re-quirements, and the uncertainty of the procedure was adequately evaluated. The established reference method could be used for traceability and standardization.%目的 建立血清总蛋白(TP)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)相关文件要求建立血清TP参考方法,对仪器、试剂、加样、温度等主要试验条件进行确认和优化,对方法灵敏度、精密度、线性、准确度进行评价,测量结果不确定度根据ISO不确定度评估指南进行评估.结果 参考方法使用的仪器设备及试剂性能满足方法要求;反应条件为37 ℃孵育10 min;方法灵敏度为0.005 82,室内测量不精密度小于0.7%,0～120 g/L线性范围良好;室间比对结果无统计学差异(P>0.05);参加TP国际参考实验室质量比对计划,样本测定结果在等效范围内,相对标准不确定度1.8%.结论 成功建立血清TP参考方法,性能指标满足要求,初步评估了测量结果不确定度,可用于TP测定的量值溯源和标准化.
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