迈瑞BS–2800M全自动生化分析仪检测系统性能验证  

Mindray BS-2800M automatic biochemical analyzer test system performance verification

作　　者：李姗姗 李雨艳 宋丽影 周婷婷 孙配龙 LI Shan-Shan;LI Yu-Yan;SONG Li-Ying;ZHOU Ting-Ting;SUN Pei-Long(Jilin Jinyu Medical Laboratory Co.,Ltd.,Changchun 130000,China)

机构地区：[1]吉林金域医学检验所有限公司,长春130000

出　　处：《实验室检测》2024年第9期134-138,共5页Laboratory Testing

摘　　要：目的通过验证丙氨酸氨基转移酶(ALT)等16个项目的性能指标,评估本实验室新投入使用的迈瑞厂家生产的全自动生化分析仪BS–2800M的检测系统性能,从而提高检验科工作质量,以确保检验结果的准确可靠。方法根据验证检测项目方法的正确度、精密度、线性范围、参考区间等,对丙氨酸氨基转移酶(ALT)等16个检测项目作出方法性能评价,在此次评价过程中未发现性能不可接受的状况,说明该检测方法的分析性能被接受,满足临床标本检测的要求。整个验证过程依据《医学实验室质量和能力认可准则在临床化学检验领域的要求》,参考CLSI EP15–A3、EP6、C28–A2和EP15–A23文件的要求。结果经验证16个项目的相对偏倚均<1/2允许总误差(TEa);精密度批内变异系数(CV)均<1/4TEa,总CV均<1/3TEa,16个项目的b值均在1.00±0.03范围内,且r^(2)≥0.95;最大稀释度及临床可报告范围均通过验证,符合需求。结论所验证16个检测项目的正确度、精密度、线性及临床可报告范围等性能均符合质量目标的要求,可以用于临床检测。Objective Goal by verifying the performance indicators of 16 items such as alanine aminotransferase(ALT),the performance of the detection system of BS-2800M,a fully automatic biochemical analyzer produced by Mindray manufacturer,which was newly put into use in this laboratory was evaluated,so as to improve the work quality of the laboratory and ensure the accuracy and reliability of the test results.Methods According to the accuracy,precision,linear range and reference interval of the test items,the performance of 16 test items such as alanine aminotransferase(ALT)was evaluated.No unacceptable performance was found in the evaluation process,indicating that the analytical performance of the test method was accepted and met the requirements of clinical specimen detection.The entire validation process is based on the Requirements of the Guidelines for the Accreditation of Quality and Competence of Medical Laboratories in the Field of Clinical Chemistry Examination,referring to the requirements of CLSI EP15-A3,EP6,C28-A2 and EP15-A23 documents.Results The relative bias of 16 items was<1/2 total allowable error(TEa).The coefficient of variation(CV)in precision batch was<1/4 tea,the total CV was<1/3 tea,the b values of 16 items were in the range of 1.00±0.03,and r^(2) was≥0.95.The maximum dilution and clinical reportable range were verified and met the requirements.Conclusion The accuracy,precision,linearity and clinical reportable range of the 16 tested items meet the requirements of quality objectives and can be used for clinical detection.

关 键 词：迈瑞BS–2800M 正确度 精密度 线性 

分 类 号：R446.1[医药卫生—诊断学]