具有溯源性和互换性的总蛋白标准物质在常规系统中的应用  

The Application of Total Protein Reference Materials with Traceability and Commutability in Conventional Systems

作　　者：孙江漫 李增心 邵燕[1] 马莉 陶世萍 于洪远[1] SUN Jiangman;LI Zengxin;SHAO Yan;MA Li;TAO Shiping;YU Hongyuan(Beijing Aerospace General Hospital Clinical Laboratory,Beijing 100076,China)

机构地区：[1]北京航天总医院检验科,北京100076

出　　处：《标记免疫分析与临床》2024年第7期1333-1337,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的探讨具有溯源性和互换性的总蛋白标准物质在常规系统中的应用。方法采用TP参考方法和常规方法同时测量GBW09186~188、RELA 23A、23B、21B、20B,51份单人份血清样本,将常规系统中标准物质的理论值和实测值进行线性拟合,单人份血清样本测量值代入拟合方程得出标准物质校准后的结果,参考CLSI EP9-A3,将校准前后的结果与参考方法的测量结果进行比对。结果常规系统测量国际比对样本校准前后的偏倚范围分别为-1.88%~-1.05%、-0.43%~0.41%,经冰冻人血清总蛋白标准物质校准后比对样本的偏倚明显降低。Bland-Altman图型分析实测值与参考方法结果的偏倚范围-4.98%~-0.33%,均为负偏倚,常规系统存在系统误差。校准后的偏倚范围-3.59%~1.28%,平均偏倚-0.43%,接近零点,经标准物质校准可以改善系统误差。实测值的4种回归分析中45g/L医学决定水平处的预期偏倚均大于临床可接受范围,经冰冻人血清总蛋白标准物质校准后的预期偏倚均在临床可接受范围内。结论将具有溯源性和互换性的冰冻人血清总蛋白标准物质作为常规系统的校准品可以保证检测结果的准确性和可比性。Objective To explore the application value of total protein reference materials with traceability and commutability in conventional systems.Methods TP reference method and the conventional method were used to measure GBW09186-188,RELA 23A,23B,21B,20B,and 51 single serum samples simultaneously.Each sample was measured twice,and the theoretical and measured values of the standard substance were linearly fitted.The measured values of all individual serum samples were substituted into the fitting equation to obtain the calibrated results of the reference materials.Referring to CLSI EP9-A3,the results before and after calibration were compared with results of the reference method.Results The bias ranges of the conventional system for measuring international comparison samples before and after calibration were-1.88%--1.05%and-0.43%-0.41%,respectively.After calibration with total protein in frozen human serum,the comparative bias was significantly reduced.The bias range between the measured values and the results of the reference method in Bland-Altman diagram was-4.98%--0.33%,both of which were negative bias,suggesting that systematic error was existing in the conventional system.The calibrated bias range was-3.59%-1.28%,with an average bias of-0.43%,which was close to zero.Calibration with reference materials was able to reduce the system error.The expected bias at the medical decision level of 45g/L in the four regression analyses of measured values was greater than the clinically acceptable range,and the expected bias after calibration by total protein in frozen human serum was within the clinically acceptable range.Conclusion Using total protein in frozen human serum with traceability and commutability as calibration standards for conventional systems can ensure the accuracy and comparability of detection results.

关 键 词：总蛋白 参考方法 参考物质 常规方法 校准品 方法学比对 

分 类 号：R-331[医药卫生]