LIAISON XL免疫分析仪检测性能验证及评价  

Performance Verification and Evaluation of LIAISON XL Auto-chemiluminescent Immunoassay Analyzer

作　　者：王强[1,2] 王东生[2] 凡瞿明[2] 汪光蓉[1,2] 卢小岚[2] 林芳[1,2] 何兰[2] 张国元[2] 

机构地区：[1]川北医学院医学检验系,四川南充637000 [2]川北医学院附属医院检验科,四川南充637000

出　　处：《现代检验医学杂志》2014年第4期132-134,138,共4页Journal of Modern Laboratory Medicine

基　　金：“十二五”国家科技支撑计划（2012BAK25800）.

摘　　要：目的 通过对血清中游离三碘甲状腺原氨酸（FT3）、游离甲状腺素（FT4）和超敏促甲状腺激素（TSH）的检测,验证和评价LIAISON XL免疫分析仪的检测性能.方法 参照美国临床实验室标准化委员会（NCCLS）文件,利用临床实验室自身条件,收集临床标本并采用LIAISON XL免疫分析仪检测FT3,FT4和TSH的天内精密度、天间精密度、携带污染率、回收率、分析灵敏度、功能灵敏度和线性范围,并与LIAISON免疫分析仪检测FT3,FT4和TSH结果进行相关性分析.结果 LIAISON XL免疫分析仪检测FT3,FT4和TSH的天内和天间不精密度XV％均＜8％;携带污染率＜1％;回收率为93％～107％;分析灵敏度分别为0.218 pmol/L（FT3）,0.510 pmol/L（FT4）和0.0030 mIU/L（TSH）;天间不精密度（CV％）为10％时的功能灵敏度分别为1.150 pmol/L（FT3）,2.550 pmol/L（FT4）和0.030 mIU/L（TSH）;FT3,FT4和TSH检测结果分别在1.726～32.68 pmol/L,5.521～107.5 pmol/L和0.007～96.50 mIU/L范围内分别符合二次、三次和一次方程的线性关系;LIAISON XL免疫分析仪检测FT3,FT4和TSH结果与LIAISON免疫分析仪检测结果相关性分析,r2均＞0.99.结论 LIAISON XL免疫分析仪的稳定性、准确性和灵敏度等方面均符合临床实验室要求,值得推广.Objective The concentration of free triiodothyronine （FT3）,free thyroxine （FT4） and thyroid stimulating hormone （TSH） were detected to verify and evaluate the performance of LIAISON XL analyzer.Methods This study based on guidance from documents of National Committee for Clinical Laboratory Standards （NCCLS）.FT3,FT4 and TSH in serum were detected to evaluate the precision,carryover,recovery,analytical sensitivity,functional sensitivity of LIAISON XL analyzer and linear range of LIAISON XL analyzer,and the correlation between LIAISON XL analyzer and LIAISON analyzer.Results All of the intraassay and inter assay variation CV％ were less than 8％,the rate of carryover were less than 1％ and the rate of recovery were between 93％ to 107％.The analytical and functional sensitivity were 0.218 vs 1.150 pmol/L （FT3）,0.510 vs 2.550 pmol/L （FT4） and 0.0030 vs 0.030 mIU/L （TSH）,respectively.In the range of 1.726～32.68 pmol/L （FT3）,5.521～107.5 pmol/L （FT4） and 0.007～96.50 mIU/L （TSH）,the test results were fit to quadratic,cubic and linear equations relationship respectively.Compared with LIAISON analyzer,all of the correlation coefficient （r2） of three test were greater than 0.99.Conclusion LIAISON XL analyzer is worthwhile to spread for its stability,accuracy and sensitivity are conformed with the clinical laboratory,sexpectations.

关 键 词：LIAISON XL分析仪 性能验证 性能评价 

分 类 号：R446[医药卫生—诊断学]