Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies
A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin–streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (C...
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| Veröffentlicht in: | Journal of virological methods 2011, Vol.171 (1), p.163-168 |
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| container_title | Journal of virological methods |
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| creator | He, Jing Xiu, Bingshui Wang, Guohua Chen, Kun Feng, Xiaoyan Song, Xiaoguo Zhu, Cuixia Ling, Shigan Zhang, Heqiu |
| description | A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin–streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies. |
| doi_str_mv | 10.1016/j.jviromet.2010.10.019 |
| format | Article |
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Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies.</description><identifier>ISSN: 0166-0934</identifier><identifier>EISSN: 1879-0984</identifier><identifier>DOI: 10.1016/j.jviromet.2010.10.019</identifier><identifier>PMID: 21029749</identifier><identifier>CODEN: JVMEDH</identifier><language>eng</language><publisher>Kidlington: Elsevier B.V</publisher><subject>antigens ; Antigens, Viral ; Biological and medical sciences ; Biotin–streptavidin amplification system ; blood ; China ; chronic hepatitis C ; Double-antigen sandwich ELISA ; enzyme-linked immunosorbent assay ; Enzyme-Linked Immunosorbent Assay - methods ; Fundamental and applied biological sciences. Psychology ; HCV antibody ; Hepacivirus - immunology ; Hepatitis C - diagnosis ; Hepatitis C Antibodies - blood ; Hepatitis C virus ; Humans ; immunoblotting ; immunoglobulin G ; Immunoglobulin G - blood ; immunoglobulin M ; Immunoglobulin M - blood ; Microbiology ; patients ; recombinant antibodies ; Sensitivity and Specificity ; Techniques used in virology ; Virology ; Virology - methods ; viruses</subject><ispartof>Journal of virological methods, 2011, Vol.171 (1), p.163-168</ispartof><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c453t-551ef01f0aea560efbe670277a51e0fa8788792c87420502ca559a78271abef3</citedby><cites>FETCH-LOGICAL-c453t-551ef01f0aea560efbe670277a51e0fa8788792c87420502ca559a78271abef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jviromet.2010.10.019$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,4024,27923,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23751110$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21029749$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>He, Jing</creatorcontrib><creatorcontrib>Xiu, Bingshui</creatorcontrib><creatorcontrib>Wang, Guohua</creatorcontrib><creatorcontrib>Chen, Kun</creatorcontrib><creatorcontrib>Feng, Xiaoyan</creatorcontrib><creatorcontrib>Song, Xiaoguo</creatorcontrib><creatorcontrib>Zhu, Cuixia</creatorcontrib><creatorcontrib>Ling, Shigan</creatorcontrib><creatorcontrib>Zhang, Heqiu</creatorcontrib><title>Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies</title><title>Journal of virological methods</title><addtitle>J Virol Methods</addtitle><description>A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin–streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies.</description><subject>antigens</subject><subject>Antigens, Viral</subject><subject>Biological and medical sciences</subject><subject>Biotin–streptavidin amplification system</subject><subject>blood</subject><subject>China</subject><subject>chronic hepatitis C</subject><subject>Double-antigen sandwich ELISA</subject><subject>enzyme-linked immunosorbent assay</subject><subject>Enzyme-Linked Immunosorbent Assay - methods</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HCV antibody</subject><subject>Hepacivirus - immunology</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C Antibodies - blood</subject><subject>Hepatitis C virus</subject><subject>Humans</subject><subject>immunoblotting</subject><subject>immunoglobulin G</subject><subject>Immunoglobulin G - blood</subject><subject>immunoglobulin M</subject><subject>Immunoglobulin M - blood</subject><subject>Microbiology</subject><subject>patients</subject><subject>recombinant antibodies</subject><subject>Sensitivity and Specificity</subject><subject>Techniques used in virology</subject><subject>Virology</subject><subject>Virology - methods</subject><subject>viruses</subject><issn>0166-0934</issn><issn>1879-0984</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu3CAQQFHVqtkm_YWUS9WTNwM2Bt8abdM20ko9ZHNGGA9ZVl6zBTtV_744u2mOOYFm3jDDG0IuGSwZsPpqt9w9-hj2OC45PAWXwJo3ZMGUbApoVPWWLDJY53tZnZEPKe0AQMiyfE_OOAPeyKpZkM23MLU9FmYY_QMONJmh--Ptlt6sb--uqQuRjlukHY5oRx8GGhyd2WKLBzP60Se6onmSKT2F29B5TBfknTN9wo-n85xsvt9sVj-L9a8ft6vrdWErUY6FEAwdMAcGjagBXYu1BC6lyQlwRkmVP8OtkhUHAdwaIRojFZfMtOjKc_Ll-Owhht8TplHvfbLY92bAMCWtaihVpZr6dZIz0ci6Upmsj6SNIaWITh-i35v4VzPQs3m908_m9Wx-jmfzufDy1GJq99j9L3tWnYHPJ8Aka3oXzWB9euFKKRhjkLlPR86ZoM1DzMz9Xe5Uz-tTvGKZ-HokMLt99Bh1sh4Hi52PeUu6C_61af8B-UKtXg</recordid><startdate>2011</startdate><enddate>2011</enddate><creator>He, Jing</creator><creator>Xiu, Bingshui</creator><creator>Wang, Guohua</creator><creator>Chen, Kun</creator><creator>Feng, Xiaoyan</creator><creator>Song, Xiaoguo</creator><creator>Zhu, Cuixia</creator><creator>Ling, Shigan</creator><creator>Zhang, Heqiu</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>FBQ</scope><scope>IQODW</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>7U9</scope><scope>H94</scope></search><sort><creationdate>2011</creationdate><title>Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies</title><author>He, Jing ; Xiu, Bingshui ; Wang, Guohua ; Chen, Kun ; Feng, Xiaoyan ; Song, Xiaoguo ; Zhu, Cuixia ; Ling, Shigan ; Zhang, Heqiu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c453t-551ef01f0aea560efbe670277a51e0fa8788792c87420502ca559a78271abef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>antigens</topic><topic>Antigens, Viral</topic><topic>Biological and medical sciences</topic><topic>Biotin–streptavidin amplification system</topic><topic>blood</topic><topic>China</topic><topic>chronic hepatitis C</topic><topic>Double-antigen sandwich ELISA</topic><topic>enzyme-linked immunosorbent assay</topic><topic>Enzyme-Linked Immunosorbent Assay - methods</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HCV antibody</topic><topic>Hepacivirus - immunology</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis C Antibodies - blood</topic><topic>Hepatitis C virus</topic><topic>Humans</topic><topic>immunoblotting</topic><topic>immunoglobulin G</topic><topic>Immunoglobulin G - blood</topic><topic>immunoglobulin M</topic><topic>Immunoglobulin M - blood</topic><topic>Microbiology</topic><topic>patients</topic><topic>recombinant antibodies</topic><topic>Sensitivity and Specificity</topic><topic>Techniques used in virology</topic><topic>Virology</topic><topic>Virology - methods</topic><topic>viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>He, Jing</creatorcontrib><creatorcontrib>Xiu, Bingshui</creatorcontrib><creatorcontrib>Wang, Guohua</creatorcontrib><creatorcontrib>Chen, Kun</creatorcontrib><creatorcontrib>Feng, Xiaoyan</creatorcontrib><creatorcontrib>Song, Xiaoguo</creatorcontrib><creatorcontrib>Zhu, Cuixia</creatorcontrib><creatorcontrib>Ling, Shigan</creatorcontrib><creatorcontrib>Zhang, Heqiu</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of virological methods</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>He, Jing</au><au>Xiu, Bingshui</au><au>Wang, Guohua</au><au>Chen, Kun</au><au>Feng, Xiaoyan</au><au>Song, Xiaoguo</au><au>Zhu, Cuixia</au><au>Ling, Shigan</au><au>Zhang, Heqiu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies</atitle><jtitle>Journal of virological methods</jtitle><addtitle>J Virol Methods</addtitle><date>2011</date><risdate>2011</risdate><volume>171</volume><issue>1</issue><spage>163</spage><epage>168</epage><pages>163-168</pages><issn>0166-0934</issn><eissn>1879-0984</eissn><coden>JVMEDH</coden><abstract>A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin–streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies.</abstract><cop>Kidlington</cop><pub>Elsevier B.V</pub><pmid>21029749</pmid><doi>10.1016/j.jviromet.2010.10.019</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of virological methods, 2011, Vol.171 (1), p.163-168 |
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| subjects | antigens Antigens, Viral Biological and medical sciences Biotin–streptavidin amplification system blood China chronic hepatitis C Double-antigen sandwich ELISA enzyme-linked immunosorbent assay Enzyme-Linked Immunosorbent Assay - methods Fundamental and applied biological sciences. Psychology HCV antibody Hepacivirus - immunology Hepatitis C - diagnosis Hepatitis C Antibodies - blood Hepatitis C virus Humans immunoblotting immunoglobulin G Immunoglobulin G - blood immunoglobulin M Immunoglobulin M - blood Microbiology patients recombinant antibodies Sensitivity and Specificity Techniques used in virology Virology Virology - methods viruses |
| title | Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies |
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