人免疫球蛋白类制品中IgA含量酶联免疫检测方法的建立及应用
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- 英文论文题名：Establishment and application of enzyme-linked immunosorbent assay for detection of immunoglobulin A in human immunoglobulin products
- 论文作者：段徐华 ; 尹红锐 ; 吴利红 ; 邵泓 ; 陈钢
- 英文论文作者：DUAN Xuhua ; Yin Hongrui ; WU Lihong ; SHAO Hong ; CHEN Gang ; Shanghai Institute for Food and Drug Control
- 年：2016
- 作者机构：上海市食品药品检验所;
- 论文关键词：人免疫球蛋白类制品 ; 免疫球蛋白A ; 含量测定 ; 酶联免疫
- 英文论文关键词：human immunoglobulin products ; immunoglobulin A ; quantitative analysis ; enzyme-linked immunosorbent assay(ELISA)
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R392-33
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：6
- 文件大小：301k
- 原文格式：O
- 会议级别：全国
摘要
目的:建立人免疫球蛋白类制品中免疫球蛋白A(IgA)含量测定的酶联免疫(ELISA)检测方法。方法:选择合适的ELISA检测试剂盒,结合使用国际标准品,建立了IgA含量测定的ELISA检测方法并对方法进行了方法学验证,最后应用此方法对来自不同企业的64批静注人免疫球蛋白(pH4)中的IgA含量进行了测定。结果:该方法的线性范围是1.5625×10~(-3)~25×10~(-3)IU/ml,标准曲线相关系数r=0.9963;平均加样回收率为102.1%(处方1)和98.5%(处方2);定量限为2.046×10~(-4)IU;精密度好(RSD<10%);专属性强,与IgGl类单抗药物无交叉反应。由于生产工艺不同,各家企业所生产的静注人免疫球蛋白(pH4)中IgA含量各不相同。结论:建立了IgA含量测定的ELISA方法,可为人免疫球蛋白类制品中IgA含量控制提供快速灵敏的检测方法。
Objective To establish a enzyme-linked immunosorbent assay(ELISA) method for the determination of immunoglobulin A(IgA) in human immunoglobulin products.Methods An appropriate ELISA kit was selected and the WHO International Standard(Immunoglobulins G,A and M,Human Serum) was used to establish the ELISA method,and then the method was verified.Finally,64 batches of Human Immunoglobulin(pH4) for Intravenous Injection from different manufacturers were investigated using the method.Results The standard curve of established ELISA was linear betweenl.5625×10~(-3) and25×10~(-3)IU/ml and the standard curve correlation coefficient(r) was 0.9963.The average recovery was102.1%(presciption 1) and 98.5%(presciption 2).The limit of quantitation was 2.046×10~(-4)IU.The precision was good with RSD<10%,and there was no cross-reactivity with other Immunoglobulins G products.Because of different manufacturing techniques,the content of IgA was different in these 64 batches of Human Immunoglobulin(pH4) for Intravenous Injection.Conclution ELISA method is well established and can be applied to the quality control of human immunoglobulin products which contain IgA.
Objective To establish a enzyme-linked immunosorbent assay(ELISA) method for the determination of immunoglobulin A(IgA) in human immunoglobulin products.Methods An appropriate ELISA kit was selected and the WHO International Standard(Immunoglobulins G,A and M,Human Serum) was used to establish the ELISA method,and then the method was verified.Finally,64 batches of Human Immunoglobulin(pH4) for Intravenous Injection from different manufacturers were investigated using the method.Results The standard curve of established ELISA was linear betweenl.5625×10~(-3) and25×10~(-3)IU/ml and the standard curve correlation coefficient(r) was 0.9963.The average recovery was102.1%(presciption 1) and 98.5%(presciption 2).The limit of quantitation was 2.046×10~(-4)IU.The precision was good with RSD<10%,and there was no cross-reactivity with other Immunoglobulins G products.Because of different manufacturing techniques,the content of IgA was different in these 64 batches of Human Immunoglobulin(pH4) for Intravenous Injection.Conclution ELISA method is well established and can be applied to the quality control of human immunoglobulin products which contain IgA.
引文
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[3]Bianchi A T J,Moonen-Leusen H W M,vander Heijden P J,Bokhout B A.The use of a double antibody sandwich ELISA and monoclonal antibodies for the assessment of porcine IgM,IgG and IgA concentrations[J].Veterinary Immunology and Immunopathology.1995,44:309-317.
[4]Hizuru N,Maiko Y,Yuki K,et al.A flow-based enzyme-linked immunosorbent assay on a polydimethylsiloxane microchip for the rapid determination of immunoglobulin A[J].Talanta,2006,70:122-127.
[5]WANG J W,WANG Z X,YANG W P.流动注射免疫比浊法测定血清中免疫球蛋白A[J].Chinese journal of analytical chemistry(分析化学),2004,32(6):724-728.
[6]梁爱惠,王娜等.IgA免疫复合物微粒的共振散射光谱研究及其分析应用[J].光谱学与光谱分析,2007,27(11):2325-2328.
[7]WANG S P.Determination of immunoglobulins,transferring and apolipoproteins by turbidimetric immunoassay[J].中国运动医学杂志,2001,20(4):392-394.
[8]CHANG Y R,SHI J,et al.透射比浊法与单向琼脂扩散法检测血清免疫球蛋白的比较和分析[J].Chinese journal of coal industry medicine(中国煤炭工业医学杂志),2004,7(12:1209-1210.
[9]刘德生.火箭免疫电泳测定免疫球蛋白及补体C3方法的改进[J].武汉医学院学报,1985,3:206-209.
[10]吴佩,姚建,王伟铭,曹红娣,董德长.血清IgA-纤连蛋白聚合物的测定及其对IgA肾病的临床意义[J].中国实验诊断学,1997,1(4):16-18.
[11]Swart R L,Vos H W,UytdeHaag F G C M,et al.Measles virus fusion protein and hemagglutinin-transfected cell lines are a sensitive tool for the detection of specific antibodies by a FACS-measured immunofluorescence assay[J].Journal of Virological Methods,1998,71:35-44.
[12]JIANG Z L,WANG N,LIANG A H.Immunonanogold Resonance Scattering Spectral Probe for Assay of Trace IgA[J].ACTA CHIMICA SINICA(化学学报),2008,66(9):1047-1052.
[13]XIANG Z F,CHU X.Anodic stripping immunoassay based on gold label for determination of immunoglobulin A[J].CHEMICAL SENSORS(化学传感器),2005,25(2):57-61.
[14]Rowe,D.S.,Andersen,S.G and Grab,B.A Research Standard for Human Serum Immunoglobulins,IgG,IgA,and IgM.Bull.Wld.Hlth.Org.1970,42,535.
[2]Peebles R,Stokes J,Liu M C,et al.IgA,IgG and IgM quantification in bronchoalveolar lavage fluids from allergic rhinitics.allergic asthmatics,and normal subjects by monoclonal antibody-based immunoenzymetric assays[J].Journal of Immunological Methods,1995,179:77-86.
[3]Bianchi A T J,Moonen-Leusen H W M,vander Heijden P J,Bokhout B A.The use of a double antibody sandwich ELISA and monoclonal antibodies for the assessment of porcine IgM,IgG and IgA concentrations[J].Veterinary Immunology and Immunopathology.1995,44:309-317.
[4]Hizuru N,Maiko Y,Yuki K,et al.A flow-based enzyme-linked immunosorbent assay on a polydimethylsiloxane microchip for the rapid determination of immunoglobulin A[J].Talanta,2006,70:122-127.
[5]WANG J W,WANG Z X,YANG W P.流动注射免疫比浊法测定血清中免疫球蛋白A[J].Chinese journal of analytical chemistry(分析化学),2004,32(6):724-728.
[6]梁爱惠,王娜等.IgA免疫复合物微粒的共振散射光谱研究及其分析应用[J].光谱学与光谱分析,2007,27(11):2325-2328.
[7]WANG S P.Determination of immunoglobulins,transferring and apolipoproteins by turbidimetric immunoassay[J].中国运动医学杂志,2001,20(4):392-394.
[8]CHANG Y R,SHI J,et al.透射比浊法与单向琼脂扩散法检测血清免疫球蛋白的比较和分析[J].Chinese journal of coal industry medicine(中国煤炭工业医学杂志),2004,7(12:1209-1210.
[9]刘德生.火箭免疫电泳测定免疫球蛋白及补体C3方法的改进[J].武汉医学院学报,1985,3:206-209.
[10]吴佩,姚建,王伟铭,曹红娣,董德长.血清IgA-纤连蛋白聚合物的测定及其对IgA肾病的临床意义[J].中国实验诊断学,1997,1(4):16-18.
[11]Swart R L,Vos H W,UytdeHaag F G C M,et al.Measles virus fusion protein and hemagglutinin-transfected cell lines are a sensitive tool for the detection of specific antibodies by a FACS-measured immunofluorescence assay[J].Journal of Virological Methods,1998,71:35-44.
[12]JIANG Z L,WANG N,LIANG A H.Immunonanogold Resonance Scattering Spectral Probe for Assay of Trace IgA[J].ACTA CHIMICA SINICA(化学学报),2008,66(9):1047-1052.
[13]XIANG Z F,CHU X.Anodic stripping immunoassay based on gold label for determination of immunoglobulin A[J].CHEMICAL SENSORS(化学传感器),2005,25(2):57-61.
[14]Rowe,D.S.,Andersen,S.G and Grab,B.A Research Standard for Human Serum Immunoglobulins,IgG,IgA,and IgM.Bull.Wld.Hlth.Org.1970,42,535.
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