应用CLSI系列文件对AC9900型电解质分析仪进行性能验证及评价  

Evaluation of AC9900 Electrolyte Analyzer by Using CLSI Documents

作　　者：洪伟 蒋丹青 杜光艳 欧斯颖 

机构地区：[1]北京中同蓝博临床检验所,北京100076

出　　处：《标记免疫分析与临床》2010年第4期259-261,共3页Labeled Immunoassays and Clinical Medicine

摘　　要：对AC9900型电解质分析仪多方面性能进行验证及评价。参考美国临床和实验室标准化协会(CLSI)系列文件和相关文献,结合工作实际,对AC9900型电解质分析仪测定K+、Na+、Cl-的精密度、准确度、可报告范围及携带污染率4大分析性能进行验证和评价,并将实验结果与厂家提供的分析性能或公认的质量指标进行比较。实验结果显示,该电解质分析仪检测的K+、Na+、Cl-三项精密度均在厂商声明的范围内,并且批内精密度小于1/4CLIA'88 TEa要求,总精密度也小于1/3CLIA'88 TEa要求,相对偏差均小于1/2 CLIA’88允许总误差,可报告范围、携带污染率都符合厂商声明范围。该系统的分析性能良好,符合临床要求。To evaluate the property of AC9900 electrolyte analyzer,the precision,accuracy,clinical reportable range and carryover of AC9900 electrolyte analyzer for the measurement of K＋,Na＋ and Cl-were evaluated and compared with the manufacture claim by using CLSI protocols.The results showed that the precision of the K＋,Na＋ and Cl-by this electrolyte analyzer were less than the value provided by manufacture claim,and the within-run precision were less than the 1/4 CLIA＇88 TEa,and the total precision were less than the 1/3CLIA＇88 TEa,the bias were less than 1/3CLIA＇88 TEa.All of the clinical reportable range and carryover were in accord with the range provided by manufacture claim.The AC9900 electrolyte analyzer is in good condition and meets clinical demands.

关 键 词：电解质分析仪 准确度 精密度 可报告范围 携带污染率 性能验证 

分 类 号：R446.1[医药卫生—诊断学]