循环增强免疫荧光法检测肌钙蛋白的检验效能评估  

Evaluation of the performance of cyclic enhanced immune fluorescence assay for the detection of cardiac troponin

作　　者：李家亮 唐文亮 曹为金 杨阳[1,3] LI Jialiang;TANG Wenliang;CAO Weijin;YANG Yang(Department of Clinical Laboratory,Nanjing Jinling Hospital Affiliated to Nanjing University/General Hospital of Eastern Theater Command,Nanjing,Jiangsu 210002,China;Nanjing Prison Hospital,Nanjing,Jiangsu 210002,China;Department of Basic Medical Laboratory,Nanjing Jinling Hospital Affiliated to Nanjing University/General Hospital of Eastern Theater Command,Nanjing,Jiangsu 210002,China)

机构地区：[1]南京大学附属金陵医院/东部战区总医院检验科,江苏南京210002 [2]江苏省南京监狱医院,江苏南京210002 [3]南京大学附属金陵医院/东部战区总医院基础医学实验室,江苏南京210002

出　　处：《检验医学与临床》2024年第S02期1-4,共4页Laboratory Medicine and Clinic

基　　金：国家自然基金青年项目(82102500);江苏省卫健委科研项目(M2020029);中国博士后特别资助项目(2022T150779);中国博士后面上项目(2020M670092ZX)。

摘　　要：目的评估Pylon3D循环增强免疫荧光法(CEIFA)肌钙蛋白T(cTnT)和肌钙蛋白Ⅰ(cTnⅠ)检测方法的检验性能。方法依据EP文件制定方案,验证Pylon3D cTnT和cTnⅠ检测试剂盒(CEIFA)的检出限(LoD)、精密度和线性范围,用临床标本分别评价Pylon3D系统与罗氏(Roche)cTnT、TOSOH cTnⅠ检测结果的关系。结果Pylon3D系统cTnT的LoD达到1 pg/mL。低浓度0.014 ng/mL时批内精密度为4.70%,批间精密度为4.124%,高浓度0.2 ng/mL时批内精密度为6.33%,批间精密度为6.55%,在3 pg/mL~10 ng/mL的范围内Pylon3D cTnT检测试剂盒有很好的线性关系。Pylon3D系统与Roche系统的结果显著相关(r^(2)=0.9874,P<0.001)。Pylon3D系统cTnⅠ的LoD达到0.5 pg/mL,低浓度0.018 ng/mL时批内精密度为4.57%,批间精密度为4.80%;高浓度0.5 ng/mL时批内精密度为6.461%,批间精密度为5.69%。在0.5 pg/mL~3 ng/mL范围内Pylon3D cTnⅠ检测试剂盒有很好的线性关系。Pylon3D系统与AIA-2000系统的结果显著相关(r^(2)=0.9024,P<0.001)。结论循环增强免疫荧光法肌钙蛋白灵敏度高、检测稳定,与化学发光法系统具有较好的相关性。Objective To evaluate the performance of the Pylon3D Cyclic enhanced immunofluorescent(CEIFA)system for the detection of Cardiac troponin T(cTnT)and troponinⅠ(cTnⅠ).Methods The limit of detection(LoD),precision and linear range of the Pylon3D system of cTnT and cTnⅠassay were validated according to EP documents.The correlation of Pylon3D system with Roche cTnT assay or the TOSOH cTnⅠassay were evaluated using clinical samples.Results The LoD of Pylon3D System cTnT was 1 pg/mL.The intra-batch and inter-batch precision were 4.70%and 4.12%at low concentration of 0.014 ng/mL,6.33%and 6.55%at high concentration of 0.2 ng/mL,respectively.In the range from 3 pg/mL to 10 ng/mL,Pylon3D cTnT assay has a good linear relationship.There was a significant correlation between pylon 3D system and Roche System(r^(2)=0.9874,P<0.001).The LoD of Pylon3D System cTnⅠwas 0.5 pg/mL,the precision of in-batch and inter-batch was 4.57%and 4.80%at low concentration of 0.018 ng/mL,6.461%and 5.69%at high concentration of 0.5 ng/mL,respectively.In the range from 0.5 pg/mL to 3 ng/mL,Pylon3D cTnⅠdetection kit has a good linear relationship.There was a significant correlation between Pylon3D system and AIA-2000 system(r^(2)=0.9024,P<0.001).Conclusion The Pylon3D assay for troponin is highly sensitive and stable in detection,and has good correlation with the routine clinical assay system.

关 键 词：循环增强免疫荧光法 肌钙蛋白Ⅰ 肌钙蛋白T 心肌损伤 电化学发光法 

分 类 号：R446[医药卫生—诊断学]