[1]李前进,戴玉柱.化学发光法测定anti-HBs的检出限和临床可报告范围的建立及临床应用[J].现代检验医学杂志,2017,32(05):122-125.[doi:10.3969/j.issn.1671-7414.2017.05.017]
　LI Qian-jin,DAI Yu-zhu.Establishment of Detection Limit and Clinical Reportable Range for Detection of Anti-HBs by Chemiluminescence Method[J].Journal of Modern Laboratory Medicine,2017,32(05):122-125.[doi:10.3969/j.issn.1671-7414.2017.05.017]
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化学发光法测定anti-HBs的检出限和临床可报告范围的建立及临床应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年05期
页码:
122-125
栏目:
研究简报·实验技术
出版日期:
2017-11-02

文章信息/Info

Title:
Establishment of Detection Limit and Clinical Reportable Range for Detection of Anti-HBs by Chemiluminescence Method
文章编号:
1671-7414(2017)05-122-04
作者:
李前进1; 戴玉柱2
1.浙江绿城心血管病医院检验科,杭州 310012; 2.解放军第117医院检验科,杭州 310013
Author(s):
LI Qian-jin1; DAI Yu-zhu2
1.Department of Clinical Laboratory, Zhejiang Greentown Cardiovascular Hospital,Hangzhou 310012,China; 2.Department of Clinical Laboratory,the 117th Hospital of PLA,Hangzhou 310013,China
关键词:
乙型肝炎表面抗体;  化学发光法;  检出限;  临床可报告范围
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.05.017
文献标志码:
A
摘要:
目的 建立化学发光法测定anti-HBs的检出限和临床可报告范围,并进行临床应用评价。方法 依据相关文件,设计化学发光法测定anti-HBs的空白限(LoB)、检出限(LoD)、定量检出限(LoQ)、分析测量范围(AMR)、临床可报告范围(CRR)的方案,并进行测量; 应用建立的临床可报告范围和最大稀释度对急性乙肝患者恢复期进行预测及2016年1～6月期间出生的51例新生儿不同疫苗接种效果的评价。结果 化学发光法测定anti-HBs的LoB,LoD,LoQ,AMR和CRR分别为0.87,1.89,3.0,0～970.50,3.0～48 525 mIU/ml,且最大稀释度为1:50; 急性乙肝患者在就诊后第4周anti-HBs就出现升高(临床可报告范围),三种疫苗接种后的anti-HBs均值以B疫苗最高。结论 化学发光法测定anti-HBs的检出限和临床可报告范围的建立能满足临床实验室的要求,为临床提供可靠的检验结果。
Abstract:
Abstract:Objective To establish detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method and evaluate by clinical application.Methods Referring to the Clinical and Laboratory Standards Institute(CLSI)relevant documents,the programme of blank limit(LoB),detection limit(LoD),quantitative detection limit(LoQ),analytical range of measurement(AMR),clinical reportable range(CRR)for detection of anti-HBs by chemiluminescence method,were designed and measured.The established clinical reportable range and maximum dilution were usedto predict the recovery stage of acute hepatitis B patients and to evaluate the effectiveness of different vaccines.Results LoB,LoD,LoQ,AMR and CRR for detection of anti-HBs by chemiluminescence method were 0.87,1.89,3.0,0～970.50 and 3.0～48 525 mIU/ml respectively,and the maximum dilution was 1:50.The patient with acute hepatitis B showed elevated anti-HBs at fourth weeks after treatment(CRR).The anti-HBs mean was the highest in the B vaccine of the three vaccines.Conclusion The establishment of detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method was better meet the requirements of clinical laboratories,provide reliable results for clinical laboratories.

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备注/Memo

备注/Memo:
作者简介:李前进(1981-),男,大学本科,从事临床免疫学检验及质量控制研究,主管技师,E-mail:15669025@qq.com。 通讯作者:戴玉柱(1985-),男,医学硕士,副主任技师,从事临床免疫学方法应用研究,E-mail:dyz5895@qq.com。
更新日期/Last Update: 1900-01-01