碱性磷酸酶常规测量系统与参考方法的比对和偏移评价  

Bias evaluation and comparison of routine methods for alkaline phosphatase with the reference method

作　　者：秦绪珍[1] 程倩[1] 徐二木[1] 叶阿里[1] 高尚 高学慧[1] 齐志宏[1] 谢少伟[1] 邱玲[1] 

机构地区：[1]北京协和医院检验科,北京100730 [2]北京市监狱管理局清河分局医院检验科,北京300481

出　　处：《临床检验杂志》2014年第4期295-298,共4页Chinese Journal of Clinical Laboratory Science

基　　金：国家临床重点专科建设项目(2011AA02A111);首都医学发展科研基金(2007-1045)

摘　　要：目的通过复现碱性磷酸酶(ALP)国际参考方法评价4种常规测量方法的正确度。方法实验室内复现国际临床化学联合会(IFCC)公布的ALP参考方法;参考临床和实验室标准化协会(CLSI)EP9-A2文件用患者新鲜血清标本将Roche Modular系统、Beckman AU系统、Siemens Dimension系统、迈克试剂-Beckman AU系统与参考方法进行比对,评价常规方法与参考方法的相关性和偏移,根据回归方程调整常规方法的系数,重新比较与参考方法的相关性和偏移。结果 4种检测体系与参考方法的相关系数r均大于0.99。与参考方法相比,Roche系统存在负偏移,Beckman AU系统、Siemens Dimension系统存在正偏移,国产迈克试剂-Beckman AU仪器系统偏移最小。通过线性回归方程调整系数后,常规方法与参考方法的结果偏移降低。结论实验室通过建立参考方法并与常规方法进行方法学比较,调整仪器参数,可最大程度地保证检测结果的可比性和准确性,是实验室内质量控制的有效手段。Objective To evaluate the trueness of 4 routine methods for alkaline phosphatase （ALP） by comparing with the Interna- tional Federation of Clinical Chemistry （IFCC） reference method for ALP. Methods The IFCC reference method for ALP at 37 ~C was set up in our laboratory. Referring to the Clinical and Laboratory Standards Institute（CLSI） EPg-A2 document, we evaluated the correlation and bias of the results between the routine methods including Roche Modular system, Beckman AU system, Siemens Dimen- sion system and Maker reagent-Beckman AU system and the reference method with the patients＇fresh blood samples. Then, the results of routine methods were adjusted using the parameters from the correlation equation, and the correlation and bias of the results between the routine methods and the reference method were reevaluated. Results The results of all of four routine methods were correlated well with that of the reference method （ r 〉 0.99）. Compared with the reference method, the Roche system showed negative bias, the Beck- man AU system and the Siemens Dimension system showed positive bias, while the Maker reagent-Beckman AU system had the minimal bias. After adjusted parameters by the correlation equation, the bias of the results between the routine methods and the reference meth- od decreased significantly. Conclusion Building the reference method in clinical laboratories and making adjustments of the routine method by comparing with the reference method may improve the accuracy and comparability of results to a maximal extent, which is an effective way for the quality control of a clinical laboratory.

关 键 词：碱性磷酸酶 参考方法 正确度 精密度 偏移 

分 类 号：R446.5[医药卫生—诊断学]