新生儿脑脊液总胆红素测定的性能评价
|
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 CVat 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.
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 CVat 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.
引文
[1] HACHIYA Y,HAYASHI M.Bilirubin encephalopathy:a study of neuronal subpopulations and neurodegenerative mechanisms in 12autopsy cases[J].Brain Dev,2008,30(4):269.
[2] OGUNLESI T A,DEDEKE I O,ADEKANMBI A F,et al.The incidence and outcome of bilirubin encephalopathy in Nigeria:a bi-centre study[J].Niger J Med,2007,16(4):354-359.
[3] BRITES D,FERNANDES A,FALCAO A S,et al.Biological risks for neurological abnormalities associated with hyperbilirubinemia[J].J Perinatol,2009,29(1):8-13.
[4]田静,阴怀清,杨金慧.新生儿血-脑脊液屏障发育及胆红素对其影响的研究进展[J].中国新生儿科杂志,2015,30(3):233-236.
[5] SGRO M,CAMPBELL D,BAROZZINO T,et al.Acute neurological findings in a National cohort of neonates with severe neonatal hyperbilirubinemia[J].J Perinatol,2011,31(6):392-396.
[6]黄华兴,易仲琼.新生儿血清胆红素对其听力的影响[J].中国妇幼保健,2008,23(30):4288-4289.
[7]吴晓翠,陈新.新生儿黄疸[M].北京:人民军医出版社,2001:156-157.
[8]高建慧,杨华姿,陈宇明,等.新生儿重度高间接胆红素血症脑脊液胆红素浓度测定及其临床意义[J].中华围产医学杂志,2004,7(1):52-53.
[9]程琪,金瑞峰,杨春燕,等.脑脊液中未结合胆红素检测在高胆红素血症新生儿中的临床应用价值[J].中国妇幼保健,2014,29(27):4423-4425.
[10]李先红,张健,郑洪,等.新生儿胆红素脑病脑脊液总胆红素及颅脑MRI检查的临床意义[J].实用临床医学,2014,15(4):76-79.
[11]孙路璐,金玉莲,刘光辉,等.新生儿脑脊液胆红素在胆红素脑病诊断中的研究[J].中华全科医学,2013,11(8):1181-1183.
[12]马红梅.新生儿病理性黄疸患儿血清与脑脊液胆红素水平变化及其在病情评估中的价值[J].临床合理用药,2016,9(1):92-93
[13]高金萍,王琨.脑脊液胆红素,头颅MRI,BAEP及NBNA在新生儿胆红素脑病早期诊断中的价值[J].现代中西医结合杂志,2016,25(29):3279-3281.
[14]中华人民共和国卫生部.WS/T 403-2012,临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2012.
[15]俞善昌.新生儿胆红素脑病的危险因素与发病机制[J].中国实用儿科杂志,1999,14(2):6-8.
[2] OGUNLESI T A,DEDEKE I O,ADEKANMBI A F,et al.The incidence and outcome of bilirubin encephalopathy in Nigeria:a bi-centre study[J].Niger J Med,2007,16(4):354-359.
[3] BRITES D,FERNANDES A,FALCAO A S,et al.Biological risks for neurological abnormalities associated with hyperbilirubinemia[J].J Perinatol,2009,29(1):8-13.
[4]田静,阴怀清,杨金慧.新生儿血-脑脊液屏障发育及胆红素对其影响的研究进展[J].中国新生儿科杂志,2015,30(3):233-236.
[5] SGRO M,CAMPBELL D,BAROZZINO T,et al.Acute neurological findings in a National cohort of neonates with severe neonatal hyperbilirubinemia[J].J Perinatol,2011,31(6):392-396.
[6]黄华兴,易仲琼.新生儿血清胆红素对其听力的影响[J].中国妇幼保健,2008,23(30):4288-4289.
[7]吴晓翠,陈新.新生儿黄疸[M].北京:人民军医出版社,2001:156-157.
[8]高建慧,杨华姿,陈宇明,等.新生儿重度高间接胆红素血症脑脊液胆红素浓度测定及其临床意义[J].中华围产医学杂志,2004,7(1):52-53.
[9]程琪,金瑞峰,杨春燕,等.脑脊液中未结合胆红素检测在高胆红素血症新生儿中的临床应用价值[J].中国妇幼保健,2014,29(27):4423-4425.
[10]李先红,张健,郑洪,等.新生儿胆红素脑病脑脊液总胆红素及颅脑MRI检查的临床意义[J].实用临床医学,2014,15(4):76-79.
[11]孙路璐,金玉莲,刘光辉,等.新生儿脑脊液胆红素在胆红素脑病诊断中的研究[J].中华全科医学,2013,11(8):1181-1183.
[12]马红梅.新生儿病理性黄疸患儿血清与脑脊液胆红素水平变化及其在病情评估中的价值[J].临床合理用药,2016,9(1):92-93
[13]高金萍,王琨.脑脊液胆红素,头颅MRI,BAEP及NBNA在新生儿胆红素脑病早期诊断中的价值[J].现代中西医结合杂志,2016,25(29):3279-3281.
[14]中华人民共和国卫生部.WS/T 403-2012,临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2012.
[15]俞善昌.新生儿胆红素脑病的危险因素与发病机制[J].中国实用儿科杂志,1999,14(2):6-8.