迈克全自动化学发光仪测定促甲状腺激素的性能验证  

Performance evaluation of Maker automated chemiluminescence analyzer in thyroid hormone detection

作　　者：王萍[1] 魏红璐[1] 

机构地区：[1]重庆市第五人民医院检验科,400062

出　　处：《检验医学与临床》2015年第4期473-475,共3页Laboratory Medicine and Clinic

摘　　要：目的通过对迈克IS1200全自动化学发光测定仪进行性能验证及评价,探讨迈克IS1200全自动化学发光测定仪临床应用的可行性。方法参考ISO15189:2007《医学实验室质量和能力认可准则》的国际标准和相关文献,同时结合实际工作,对IS1200的稳定性、精密度、正确度、线性相关性、携带污染率、仪器间的比对等分析性能进行验证及评价。结果迈克IS1200仪器性能稳定,稳定性试验4h后的相对偏倚为3.43%,8h后的相对偏倚为5.04%,批内不精密度小于5%,总不精密度小于10%,携带污染率小于2ppm,线性相关系数为0.999 92。结论迈克IS1200仪器稳定性较好,线性良好,携带污染率低,良好的精密度和正确度,可应用于临床。Objective To explore the feasibility of clinical applications of Maker IS1200 automated chemiluminescent analyzer based on the performance verification and evaluation.Methods According to the standard of ISO15189：2007established by Chinese Pharmaceutical Industry,related literature,and combined with practical work,the stability,precision,accuracy,linearity correlation,carryover contamination rate and comparison between different instrument of IS1200 were conducted.Results The relative bias was 3.43% after 4 hstability test and 5.04% after 8.In the same batch,the imprecision was less than 5%,the total imprecision was less than 10%,and carryover contamination rate was less than 2ppm,the linear correlation coefficient was 0.999 92.Conclusion The Maker IS1200 could be applied in clinica due to the stabile performance,good linearity,low carryover contamination rate,good precision and accuracy.

关 键 词：全自动化学发光测定仪 精密度 携带污染率 正确度 

分 类 号：R512.8[医药卫生—内科学]