新生儿脑脊液总胆红素测定的性能评价  

Performance evaluation for detecting total bilirubin in neonatal cerebrospinal fluid

作　　者：刘非 邱先桃 陈小娟 蔡敏敏 麻庆玲 庞舒尹 刘海英 LIU Fei;QIU Xiantao;CHEN Xiaojuan;CAI Minmin;MA Qingling;PANG Shuyin;LIU Haiying(Department of Clinical Laboratory,Guangzhou Women and Children′s Medical Center,Guangzhou,Guangdong 510623,China)

机构地区：[1]广州市妇女儿童医疗中心检验部,广东广州510623

出　　处：《国际检验医学杂志》2019年第4期385-387,391,共4页International Journal of Laboratory Medicine

基　　金：广东省科技厅社会发展项目(2014A020212520)

摘　　要：目的新生儿胆红素脑病严重威胁新生儿的生命和健康,其病死率及致残率很高。为满足临床需求,对检验科现有血清胆红素检测系统进行脑脊液胆红素检测的性能确认。方法评价内容包括精密度、正确度、准确度、分析测量范围和回收试验。结果检测系统在1.0～25.1μmol/L时呈线性,且在正常值和病理值浓度处的日间变异系数(CV)均小于行业标准规定的精密度要求(6%);每个样本的偏倚和平均偏倚均小于行业标准规定允许偏倚(5%),总误差小于允许总误差(15%)。结论该检测系统的性能满足行业标准要求,可用于新生儿脑脊液胆红素检测。Objective Newborn bilirubin encephalopathy seriously threatens the life and health of newborns,Both the mortality and morbidity are high.Cerebrospinal fluid bilirubin concentration can better reflect the blood-brain barrier function and brain bilirubin levels,which can help the diagnosis of bilirubin encephalopathy.Methods In order to meet the clinical needs,we confirmed the detection performance of the existing serum bilirubin detection system for cerebrospinal fluid bilirubin,including precision,accuracy and analysis of measurement range.Results The results showed that the detection system was linear at 1.0-25.1μmol/L,and the daytime CV at normal and pathological values was less than the precision requirement(6%).The bias of each sample and the average bias are less than the allowable bias(5%),the total error is less than the total allowable error(15%).Conclusion Therefore,the performance of the detection system meet the industry standards,can be used for neonatal cerebrospinal fluid bilirubin detection.

关 键 词：新生儿 脑脊液 胆红素 性能评价 

分 类 号：R446.14[医药卫生—诊断学]