基于时间分辨免疫荧光法的降钙素原试剂盒临床性能评价  

Clinical Performance Evaluation of Procalcitonin Kit Based on Time-Resolved Immunofluorescence Method

作　　者：李登红 陆建伟 王洪涛 蔡美玲 农丽松 黄光强 Li Denghong;Lu Jianwei;Wang Hongtao;Cai Meiling;Nong Lisong;Huang Guangqiang(Boditech(Guangxi)Biotechnology Co.,Ltd,Nanning Guangxi 530031,China;Department of Clinical Laboratory,The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning Guangxi 530022,China)

机构地区：[1]巴迪泰(广西)生物科技有限公司,广西南宁530031 [2]广西中医药大学第一附属医院检验科,广西南宁530022

出　　处：《医疗装备》2021年第21期52-54,共3页Medical Equipment

基　　金：南宁市科学研究与技术开发计划项目(20201070)。

摘　　要：目的以酶联免疫荧光法作为对照,将时间分辨免疫荧光法应用于临床上分析降钙素原(PCT)的含量,评价两种方法学的一致性,以为临床上挑选PCT试剂盒提供参考。方法以酶联免疫荧光法(法国生物梅里埃股份有限公司生产的PCT测定试剂盒)作为对照,对时间分辨免疫荧光法[超敏PCT(PCT plus)检测试剂盒]开展性能指标方面的评价。结果时间分辨免疫荧光法检测PCT的变异系数(CV)<10%,和酶联免疫荧光法的偏差为3.88%,两种分析方法成线性,相关系数r=0.9911,在Cut Off值(0.5 ng/ml)下的ROC曲线下面积为0.990,P<0.01,灵敏度为95.29%,特异度为98.44%,Kappa值为0.891。结论时间分辨免疫荧光法检测PCT的结果良好,表现在检测重复性良好,和酶联免疫荧光法偏差小,相关性高,一致性好,用户可结合实际情况选择时间分辨免疫荧光法的PCT试剂盒。Objective The consistency of enzyme-linked immunofluorescence which was taken as the control and the time-resolved immunofluorescence assay in detecting the content of procalcitonin(PCT)in clinic was evaluated,so as to provide references for clinical selection of PCT kits.Methods Taken the enzyme-linked immunofluorescence assay(PCT test kit from French BioMerierre Co.,Ltd.)as the control,the performance indexes of time-resolved immunofluorescence assay[hyper sensitivity PCT(PCT plus)test kit]were evaluated.Results The coefficient of variation(CV)of PCT detected by time-resolved immunofluorescence assay was less than 10%,and the deviation was 3.88%compared with enzyme-linked immunofluorescence assay.The two methods were linear,and the correlation coefficient was 0.9911.The area under the ROC curve under the cut-off value of 0.5 ng/ml was 0.990,P<0.01.The sensitivity was 95.29%,the specificity was 98.44%,and the Kappa value was 0.891.Conclusion The results of PCT detection by time-resolved immunofluorescence method were good,with good detection repeatability,small deviation and high correlation and consistency compared with enzyme-linked fluorescent assay.Users can choose the PCT kit of time-resolved immunofluorescence assay according to the actual situation.

关 键 词：降钙素原 酶联免疫荧光法 时间分辨免疫荧光法 性能评价 

分 类 号：R446.6[医药卫生—诊断学]