{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T12:21:31Z","timestamp":1784290891144,"version":"3.55.0"},"reference-count":20,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,12,14]],"date-time":"2015-12-14T00:00:00Z","timestamp":1450051200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"RayBiotech innovative research fund","award":["2013L-P255"],"award-info":[{"award-number":["2013L-P255"]}]},{"name":"Program of hundred leading innovators and entrepreneurs","award":["LCY201111"],"award-info":[{"award-number":["LCY201111"]}]},{"DOI":"10.13039\/100012540","name":"Guangdong innovative research team program","doi-asserted-by":"crossref","award":["201001s0104659419"],"award-info":[{"award-number":["201001s0104659419"]}],"id":[{"id":"10.13039\/100012540","id-type":"DOI","asserted-by":"crossref"}]},{"name":"UK-China (Guangzhou) Healthtech Open Innovation","award":["2012Q-P182"],"award-info":[{"award-number":["2012Q-P182"]}]},{"name":"Guangzhou Municipal Innovation Fund","award":["2013J4400170"],"award-info":[{"award-number":["2013J4400170"]}]},{"name":"Foundation of Enterprise University Research Institute Cooperation of Guangdong Province and Ministry of Education of China","award":["2012B090600021"],"award-info":[{"award-number":["2012B090600021"]}]},{"name":"Special program for the development of technology business incubators in Guangzhou","award":["2013J4200016"],"award-info":[{"award-number":["2013J4200016"]}]},{"name":"Guangzhou economic development district","award":["2010Q-P450"],"award-info":[{"award-number":["2010Q-P450"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The human epididymis protein 4 (HE4) may have high specificity in the detection of malignant diseases, making the development of an immunoassay for HE4 essential.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In our study, a fusion gene was constructed encoded with the HE4 protein. This protein was then produced in the bacterial cells (<jats:italic>Escherichia coli<\/jats:italic>) and used to immunize mice in order to eventually generate hybridomas specific to HE4. The hybridoma supernatants were then screened, and four positive anti\u2010HE4 cell lines were selected. These cell lines produce monoclonal antibodies against HE4 epitopes, as demonstrated in the Western blot as well as by direct enzyme\u2010linked immunosorbent assay (ELISA). Using the developed antibodies, we successfully identified several good antibody pairs from the hybridomas, which allowed for the development of a sandwich ELISA to measure HE4 levels. By using the HE4 ELISA, we measured HE4 levels of 60 clinical human serum samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared with the Food and Drug Administration (FDA) approved kit (Roche), our results showed a strong positive correlation to those of the FDA\u2010approved kit.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In summary, highly sensitive antibody pairs were screened against HE4, and a sandwich ELISA was developed as an accurate analytical tool for the detection of HE4 in human serum, which could be especially valuable for diagnosing ovarian carcinomas.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.21906","type":"journal-article","created":{"date-parts":[[2015,12,15]],"date-time":"2015-12-15T04:03:24Z","timestamp":1450152204000},"page":"581-589","source":"Crossref","is-referenced-by-count":10,"title":["Detection of Human Epididymis Protein 4 (HE4) in Human Serum Samples Using a Specific Monoclonal Antibody\u2010Based Sandwich Enzyme\u2010Linked Immunosorbent Assay (ELISA)"],"prefix":"10.1002","volume":"30","author":[{"given":"Lijun","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Clinical Laboratory, Sun Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou Guangdong Province People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiqiang","family":"Lv","sequence":"additional","affiliation":[{"name":"Raybiotech, Inc  Guangzhou Guangdong Province People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Shao","sequence":"additional","affiliation":[{"name":"Medical Research Center, the Sun Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou Guangdong Province People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of 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Yat\u2010Sen University  Guangzhou Guangdong Province People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaohui","family":"Duan","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Sun Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou Guangdong Province People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruopan","family":"Huang","sequence":"additional","affiliation":[{"name":"Raybiotech, Inc  Guangzhou Guangdong Province People's Republic of China"},{"name":"RayBiotech, Inc  Norcross Georgia"},{"name":"South China Biochip Research Center  Guangzhou Guangdong Province People's Republic of 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