生化检验项目线性范围上限验证及校正方法探讨  

The Exploration of the Method of Linear Range Upper Limit Validation and Correction in Biochemical Tests

作　　者：齐墨词 王佶图 蔡宇雨 胡梅 刘娜 QI Moci;WANG Jitu;CAI Yuyu;HU Mei;LIU Na(Department of Clinical Laboratory,Beijing Shijitan Hospital,Capital Medical University,Department of Clinical Laboratory,Peking University Ninth School of Clinical Medicine,Beijing Key Laboratory of Urinary Cellular andMolecular Diagnostics,Beijing 10038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院医学检验科,北京大学第九临床医学院医学检验科,尿液细胞分子诊断北京市重点实验室,北京100038

出　　处：《标记免疫分析与临床》2024年第10期1941-1947,共7页Labeled Immunoassays and Clinical Medicine

基　　金：首都医科大学附属北京世纪坛医院“十四五”领军人才培养项目(编号:2023LJRCZM)。

摘　　要：目的研究并确定适用于本实验室的线性验证高值样本浓度选取范围,为线性验证工作样本选取提供参考依据。方法运用实验室信息管理系统检索52个生化检验项目2023年度全部临床样本报告数值,评估临床样本是否可满足试剂盒线性上限验证需求,制定各项目样本浓度选取范围,并根据临床样本实际情况对部分项目试剂盒线性上限进行校正。结果线性验证高值浓度样本选取范围确定为“试剂盒声称线性范围上限±10%”的项目为血液ALT、CK、GGT等共8个项目;线性验证高值浓度样本选取范围确定为“试剂盒声称线性范围上限±20%”的项目为血液ALB、AST、DBIL等共8个项目;线性验证高值浓度样本选取范围确定为“试剂盒声称线性范围上限±40%”的项目为血液TBIL、TP、ALP等共26个项目;对线性上限进行校正的项目为血液IP、Fe、Cr等共13个项目。结论本实验室结合临床样本实际情况,制定了适用于本实验室的线性验证高值样本浓度选取范围,并根据临床样本实际情况对部分项目试剂盒线性上限进行了校正,以更好地指导实验室工作人员高效有序开展线性验证相关工作。Objective To investigate and identify the suitable selection range of high-value sample concentration,so as to provide a reference guide for linear validation in our laboratory.Methods The laboratory information system was used to retrieve the reported values of 52 biochemical tests of all clinical samples in 2023.We evaluated whether clinical samples could meet the requirements of linear validation of the upper limit of kits,and developed the sample concentration selection range for each item.We further adjusted the linear upper limit of kits for some items according to the actual concentration of clinical samples.Results The selection range of high-value concentration samples for linear validation was determined as“the upper limit of linear range claimed by the kit±10%”for 8 items including serum ALT,CK,and GGT,etc.The selection range of high-value concentration samples for linear validation was determined as“the upper limit of linear range claimed by the kit±20%”for 8 items including serum ALB,AST,and DBIL,etc.The selection range of high-value concentration samples for linear validation was determined as“the upper limit of linear range claimed by the kit±40%”for 26 items including serum TBIL,TP,and ALP,etc.The upper limit of the linear range was corrected for 13 items including serum IP,Fe,and Cr,etc.Conclusion Through this study,our laboratory has established the selection range of high-value sample concentration for linear validation applicable to the laboratory.We also corrected the upper limit of some kits according to the actual concentration of clinical samples,which can better guide laboratory staff to carry out linear validation more efficiently and orderly.

关 键 词：线性验证 生化项目 样本浓度选取 

分 类 号：R-331[医药卫生]