摘要
目的对基于磁微粒化学发光技术的Autolumo A2000神经元特异性烯醇化酶(NSE)项目(简称评价试剂)进行性能评价与方法学比对评估。方法按照EP文件试剂盒性能考核方法对安图NSE项目灵敏度、线性范围、精密性、回收率性能进行评估,通过磁微粒化学发光法对来自郑州市第六人民医院的临床样本538份和体检样本400份进行检测,与罗氏NSE试剂(简称参比试剂)进行方法学比对。结果NSE试剂盒检测空白限(LoB)为0.02 ng/mL,检测限(LoD)为0.26 ng/mL,功能灵敏度(FS)为0.59 ng/mL,线性范围为0.50~198.15 ng/mL。NSE试剂盒的精密度分析内、天间、试剂批间变异均<7.14%;NSE试剂盒的准确度偏差均<10%;安图Autolumo A2000 NSE项目与罗氏NSE试剂相关性较好R 2=0.9719。结论安图Autolumo A2000 NSE项目性能良好,可满足临床需求。
Objective To carriy out the performance evaluation and methodology comparison of the Autolumo A2000 neuron specific enolase(NSE)project based on the magnetic particle chemiluminescence technology.Methods Evaluated the sensitivity,linear range,precision and recovery performance of antunense project according to the performance evaluation method of EP document kit and detected 538 clinical samples and 400 medical examination samples from the Six People′s Hospital of Zhengzhou by Antu Plate chemiluminescence and Magnetic particle chemiluminescence(MRCL),and compared with Roche NSE reagent(reference reagent).Results The limit of blank(LoB)of NSE kit is 0.02 ng/mL/L,limit of detection(LoD)=0.26 ng/mL,functional sensitivity(FS)=0.59 ng/mL,the linear range is 0.50-198.15 ng/mL.Its precision variation was less than 7.14%;its Accuracy variation was less than 10%;the correlation between Antu Autolumo A2000 NSE project and Roche NSE reagent was good(R 2=0.9719).Conclusion Products of NSE of Antu Autolumo A2000 has good performance and can meet the clinical needs.
作者
冉盼盼
于志红
吕萌萌
渠文涛
史小芹
RAN Panpan;YU Zhihong;LYU Mengmeng;QU Wentao;SHI Xiaoqin(Autobio Diagnostics Co.,Ltd,Zhengzhou,Henan 450016,China;Department of Oncology Medicine,Henan Hospital of Traditional Chinese Medicine/the Second Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou,Henan 450016,China;Department of Clinical Laboratory,the Sixth People′s Hospital of Zhengzhou,Henan Province,Zhengzhou,Henan 450016,China)
出处
《国际检验医学杂志》
CAS
2020年第S01期94-97,共4页
International Journal of Laboratory Medicine
关键词
NSE
小细胞肺癌
性能评估
方法学比对
neuron specific enolase
small cell lung cancer
performance evaluation
methodology comparison
