Development, validation and use of ELISA for antibodies to human alpha-1 antitrypsin
Evaluation of human antibody responses to alpha-1 antitrypsin (AAT) in clinical trials and clinical practice has been limited by the lack of a validated assay. Here we describe the development and validation of an ELISA method for quantification of human and nonhuman primate antibody responses to hu...
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| Veröffentlicht in: | Journal of immunological methods 2013-02, Vol.388 (1-2), p.18-24 |
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| container_title | Journal of immunological methods |
| container_volume | 388 |
| creator | Ye, Guo-jie Oshins, Regina A. Rouhani, Farshid N. Brantly, Mark L. Chulay, Jeffrey D. |
| description | Evaluation of human antibody responses to alpha-1 antitrypsin (AAT) in clinical trials and clinical practice has been limited by the lack of a validated assay. Here we describe the development and validation of an ELISA method for quantification of human and nonhuman primate antibody responses to human AAT. A reference anti-human AAT serum standard was generated using sera from a cynomolgus macaque injected with a recombinant adeno-associated virus vector expressing human AAT. The ELISA was validated for use with human serum dilutions as low as 1:10 and was able to distinguish between specific responses in cynomolgus serum and non-specific increases in apparent antibody titer in serum from subjects in a clinical trial of an AAT gene therapy vector. |
| doi_str_mv | 10.1016/j.jim.2012.11.008 |
| format | Article |
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Here we describe the development and validation of an ELISA method for quantification of human and nonhuman primate antibody responses to human AAT. A reference anti-human AAT serum standard was generated using sera from a cynomolgus macaque injected with a recombinant adeno-associated virus vector expressing human AAT. 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Here we describe the development and validation of an ELISA method for quantification of human and nonhuman primate antibody responses to human AAT. A reference anti-human AAT serum standard was generated using sera from a cynomolgus macaque injected with a recombinant adeno-associated virus vector expressing human AAT. The ELISA was validated for use with human serum dilutions as low as 1:10 and was able to distinguish between specific responses in cynomolgus serum and non-specific increases in apparent antibody titer in serum from subjects in a clinical trial of an AAT gene therapy vector.</description><subject>AAT gene</subject><subject>Adeno-associated virus</subject><subject>Adeno-associated virus vector</subject><subject>alpha 1-Antitrypsin - immunology</subject><subject>alpha 1-Antitrypsin Deficiency - immunology</subject><subject>Alpha-1 antitrypsin</subject><subject>Animals</subject><subject>Antibodies</subject><subject>Antibodies - blood</subject><subject>Antibodies - immunology</subject><subject>blood serum</subject><subject>Clinical trials</subject><subject>Cynomolgus</subject><subject>ELISA</subject><subject>Enzyme-linked immunosorbent assay</subject><subject>Enzyme-Linked Immunosorbent Assay - methods</subject><subject>Enzyme-Linked Immunosorbent Assay - standards</subject><subject>Expression vectors</subject><subject>gene therapy</subject><subject>Humans</subject><subject>Macaca</subject><subject>Macaca fascicularis</subject><subject>Primates</subject><subject>viruses</subject><issn>0022-1759</issn><issn>1872-7905</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1P3DAQhi3UChbaH9AL5NgDSWecD9vqCVFokVbqAThbXn-AV0kc7GQl_n0NSzlWPY0088yr0TOEfEGoELD7tq22fqgoIK0QKwB-QFbIGS2ZgPYDWQFQWiJrxRE5TmkLAAgdHJIjWqNoOYUVufthd7YP02DH-bzYqd4bNfswFmo0xZJsEVxxtb65vShciLk5-00w3qZiDsXjMqgM9tOjKvF1NsfnKfnxE_noVJ_s57d6Qu6vr-4uf5Xr3z9vLi_WpW4Q5rLmNd-A61zdmAYMb5RuXAMNCGy4xlppzgUKxdquRUFbwQ1nDjrqauyQd_UJ-brPnWJ4Wmya5eCTtn2vRhuWJJHyFgSgwP9AWc2yQeAZxT2qY0gpWien6AcVnyWCfPEutzJ7ly_eJaKE153Tt_hlM1jzvvFXdAbO9oBTQaqH6JO8v80Jbf4JY4yzTHzfEzYb23kbZdLejtoaH62epQn-Hwf8AfvsmQY</recordid><startdate>20130228</startdate><enddate>20130228</enddate><creator>Ye, Guo-jie</creator><creator>Oshins, Regina A.</creator><creator>Rouhani, Farshid N.</creator><creator>Brantly, Mark L.</creator><creator>Chulay, Jeffrey D.</creator><general>Elsevier B.V</general><scope>FBQ</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20130228</creationdate><title>Development, validation and use of ELISA for antibodies to human alpha-1 antitrypsin</title><author>Ye, Guo-jie ; 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Here we describe the development and validation of an ELISA method for quantification of human and nonhuman primate antibody responses to human AAT. A reference anti-human AAT serum standard was generated using sera from a cynomolgus macaque injected with a recombinant adeno-associated virus vector expressing human AAT. The ELISA was validated for use with human serum dilutions as low as 1:10 and was able to distinguish between specific responses in cynomolgus serum and non-specific increases in apparent antibody titer in serum from subjects in a clinical trial of an AAT gene therapy vector.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>23195820</pmid><doi>10.1016/j.jim.2012.11.008</doi><tpages>7</tpages></addata></record> |
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| subjects | AAT gene Adeno-associated virus Adeno-associated virus vector alpha 1-Antitrypsin - immunology alpha 1-Antitrypsin Deficiency - immunology Alpha-1 antitrypsin Animals Antibodies Antibodies - blood Antibodies - immunology blood serum Clinical trials Cynomolgus ELISA Enzyme-linked immunosorbent assay Enzyme-Linked Immunosorbent Assay - methods Enzyme-Linked Immunosorbent Assay - standards Expression vectors gene therapy Humans Macaca Macaca fascicularis Primates viruses |
| title | Development, validation and use of ELISA for antibodies to human alpha-1 antitrypsin |
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