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  

Establishment of Detection Limit and Clinical Reportable Range for Detection of Anti-HBs by Chemiluminescence Method

作　　者：李前进 戴玉柱[2] 

机构地区：[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

出　　处：《现代检验医学杂志》2017年第5期122-125,共4页Journal of Modern Laboratory Medicine

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。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 used to predict the recovery stage of acute hepatitis 13 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 3.048 525 mIU/ ml respectively,and the maximum dilution was 1 ： 50. The patient with acute hepatitis 13 showed elevated anti-HBs at fourth weeks after treatment （CRR）. The anti-HBs mean was the highest in the t3 vaccine of the three vaccines. Conclusion The establishment of detection limit and clinical reportable range for detection of anti-H13s by chemiluminescence method was better meet the requirements of clinical laboratories, provide reliable results for clinical laboratories.

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[医药卫生—诊断学]