白细胞介素-6和肿瘤坏死因子测定试剂盒在仪器IMMULITE1000化学发光分析仪的性能验证  

Performance verification of interleukin-6 and tumor necrosis factor assay kit by IMMULITE1000 chemiluminescence analyzer

作　　者：张丽 孙胜利 陈倩[1] 司永珍 毛镭篥 吴卫 ZHANG Li;SUN Sheng-li;CHEN Qian;SI Yong-zhen;MAO Lei -li;WU Wei(Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院北京协和医院检验科

出　　处：《中国卫生检验杂志》2018年第23期2897-2900,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的评估SIEMENS的白介素-6(IL-6)和肿瘤坏死因子(TNF-α)试剂盒在IMMULITE1000化学发光分析仪的性能。方法根据美国临床实验室标准化研究所(CLSI)系列文件(EP15-A2、EP6-A2、C28-A2),对IL-6和TNF-α试剂盒在IMMULITE1000化学发光分析仪上性能进行验证。结果 IL-6和TNF-α批内精密度低水平分别为3. 9%和3. 24%,高水平为4. 3%和2. 8%。IL-6批间精密度低水平分别为4. 8%和6. 7%,高水平分别为4. 5%和6. 3%。IL-6与TNF-α检测值与CAP目标值的相关系数≥0. 99。IL-6线性方程为y=1. 050 9x-5. 837 5,r2=0. 993。TNF-α线性方程为y=0. 957x+1. 504,r2=0. 997。IL-6和TNF-α的携带污染率均为0%。IL-6的参考范围符合率为95%,TNF-α的参考范围符合率为100%。结论 IL-6和TNF-α试剂盒在IMMULITE1000化学发光分析仪上性能符合临床要求。Objective To evaluate the performance of interleukin 6( IL-6) and a tumor necrosis factor( TNF-α) assay kit produced by the SIEMENS by IMMULITE1000 chemiluminescence analyzer. Methods According to the files( EP15-A2,EP6-A2,C28-A2) of the Clinical Laboratory Standardization Institute( CLSI),to investigate the performance of IL-6 and TNF-α assay kit by IMMULITE1000 chemiluminescence analyzer. Results The low intra-assay precisions of IL-6 and TNF-α were 3. 9% and 3. 24%,respectively; the high precisions were 4. 3% and 2. 8%. The low IL-6 inter-assay precisions were 4. 8% and 6. 7%,respectively; the high precisions were 4. 5% and 6. 3%,respectively. The correlation coefficient between IL-6 and TNF-α detection values and CAP target value was ≥0. 99. The linear equation of IL-6 was y = 1. 0509 x-5. 8375,r2= 0. 993. The linear equation of TNF-α was y = 0. 957 x + 1. 504,r2= 0. 997. The carrying rate of IL-6 and TNF-α was 0%. The reference range of IL-6 was 95%,and the reference range of TNF-α was 100%. Conclusion IL-6 and TNF-α assay kit produced by SIEMENS is complied with clinical requirements by IMMULITE1000 chemiluminescence analyzer.

关 键 词：白介素-6 肿瘤坏死因子 性能验证 IMMULITE1000化学发光分析仪 

分 类 号：R446.6[医药卫生—诊断学]