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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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 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.
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 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.
引文
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[14]张秀明.浅析定量检验程序分析性能验证实验方案设计[J].中华检验医学杂志,2015,38(6):428-430.Zhang XM.Suggestions for analytical performance verification and experimental designs for clinical laboratory tests[J].Chinese Journal of Laboratory Medicine,2015,38(6):428-430.
[2]Kim YJ,Li P,Hong JM,et al.A single center analysis of the positivity of hepatitis B antibody after neonatal vaccination program in Korea[J].J Korean Med Sci,2017,32(5):810-816.
[3]He F,Ma YJ,Zhou TY,et al.The serum anti-HBs level among children who received routine hepatitis B vaccination during infancy in Mianyang city,China:A cross-sectional study[J].Viral Immunol,2016,29(1):40-48.
[4]Clinical Laboratory Standards Institute.Evaluation of the linearity of quantitative measurement procedures:a statistical approach;approved guideline[S].Wayne:PA,CLSI EP6-A,2003.
[5]中国合格评定国家认可委员会.CNAS-CL02:2012医学实验室质量和能力认可准则[S].北京:中国标准出版社,2012.China National Accreditation Service for Conformity Assessment.CNAS-CL02:2012 Accereditation criteria for the quality and competence of medical laboratories[S].Beijing:Standards Press of China,2012.
[6]康凤凤,王薇,王治国.临床实验室检测方法空白限、检出限和定量限评价新方法[J].中国卫生统计,2014,31(5):901-904.Kang FF,Wang W,Wang ZG.New methods for clinical laboratory test methods including limit of blank,limit of detection and limit of quantitation[J].Chinese Journal of Health Statistics,2014,31(5):901-904.
[7]张诗诗,王薇,王治国.临床检验质量控制程序的性能验证[J].现代检验医学杂志,2016,31(6):150-153,157.Zhang SS,Wang W,Wang ZG.Performance verification of quality control procedures in clinical laboratory medicine[J].Journal of Modern Laboratory Medicine,2016,31(6):150-153,157.
[8]郭绪晓,柏淑美,张春来,等.基于EP-17 A2的胶体金法检测粪便隐血的空白限、检出限及定量限的建立及评价[J].现代检验医学杂志,2015,30(1):78-81.Guo XX,Bai SM,Zhang CL,et al.Establishment and evaluation of blank limit,detection limint and quantitation limit of fecal occult blood tests with colloidal gold method based on the document of EP-1 7A2[J].Journal of Modern Laboratory Medicine,2015,30(1):78-81.
[9]周双艳,胡敏,杨泽华,等.全自动酶联免疫吸附法检测血清乙型肝炎表面抗原检测限的建立与评价[J].临床检验杂志(电子版),2014,3(4),746-749.Zhou SY,Hu M,Yang ZH,et al.The establishment and evaluation of limit of detection for detection of serum hepatitis B surface antigens by Automaticenzyme-linked immunosorbent assay[J].Clinical Laboratory Journal(Electronic Edition),2014,3(4),746-749.
[10]杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2008:142-193.Yang YY,Zhang XM.The methodology evaluation in clinical laboratory[M].Beijing:People's Medical Publishing House,2008:142-193.
[11]中国合格评审国家认可委员会.CNAS-CL38:2016医学实验室质量和能力认可准则在临床化学检验领域的应用说明[S].北京:中国标准出版社,2016.China National Accreditation Service for Conformity Assessment.CNAS-CL38:2016 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry[S].Beijing:Standards Press of China,2016.
[12]中华医学会肝病学分会,中华医学会感染病学分会.慢性乙型肝炎防治指南(2015更新版)[J].中华肝脏病杂志,2015,23(12):888-905.Chinese Society of Hepatology and Chinese Society of Infectious Diseases,China Medical Association.The guideline of prevention and treatment for chronic hepatitis B:a 2015 update[J].Chinese Journal of Hepatology,2015,23(12):888-905.
[13]刘重程,唐雅清,王瑞琴,等.不同剂量国产重组酵母乙肝疫苗成人免疫效果评价[J].中国预防医学杂志,2012,13(9):701-703.Liu ZC,Tang YQ,Wang RQ,et al.Evaluation of the immune effect of Chinese hamster ovary cell derived hepatitis B vaccine among adults[J].Chin Prev Med,2012,13(9):701-703.
[14]张秀明.浅析定量检验程序分析性能验证实验方案设计[J].中华检验医学杂志,2015,38(6):428-430.Zhang XM.Suggestions for analytical performance verification and experimental designs for clinical laboratory tests[J].Chinese Journal of Laboratory Medicine,2015,38(6):428-430.