{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T22:09:16Z","timestamp":1762898956542},"reference-count":34,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2013,7,12]],"date-time":"2013-07-12T00:00:00Z","timestamp":1373587200000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Cytokeratin 19 fragment antigen (CYFRA 21\u20131) is used to diagnose and monitor neoplasms. However, the main disadvantages of the currently available CYFRA 21\u20131 assays include heterogenous technology, being time\u2010consuming, and having low through\u2010put with low insensitivity. This study investigated the use of amplified luminescent proximity homogeneous immunoassay (AlphaLISA) for the quantization of CYFRA 21\u20131 in human serum.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The AlphaLISA kit was developed based on AlphaScreen detection technology with two different anti\u2010CYFRA 21\u20131 monoclonal antibodies. One was coated on AlphaLISA acceptor beads and the other was biotinylated. Donor beads were coated with streptavidin. The test conditions were optimized and analytical performance was studied.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The measurement range of AlphaLISA CYFRA 21\u20131 kit was 0.08\u2013500 ng\/ml. Assay detection limit was 0.08 ng\/ml. The intra\u2010 and interassay coefficients of variation were 3.00\u20139.00% and 4.00\u201310.00%, respectively. There was no cross\u2010reaction to alpha\u2010fetoprotein (AFP), carcinoembryonic antigen (CEA), neuron\u2010specific enolase (NSE), cancer antigen 19\u20139 (CA19\u20139), cytokeratins 8 (CK8), and cytokeratins 18 (CK18). The correlation coefficient of blood samples involved was 0.974 between CYFRA 21\u20131\u2010AlphaLISA assay and a commercial electrochemiluminescence immunoassay (ECLIA) CYFRA 21\u20131 kit (Roche).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The AlphaLISA CYFRA 21\u20131 kit developed in this study had favorable performance characteristics for clinical application with acceptable analytical sensitivity, specificity, and accuracy.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.21597","type":"journal-article","created":{"date-parts":[[2013,7,12]],"date-time":"2013-07-12T15:55:11Z","timestamp":1373644511000},"page":"277-283","source":"Crossref","is-referenced-by-count":27,"title":["A Novel Immunoassay for the Quantization of CYFRA 21\u20131 in Human Serum"],"prefix":"10.1002","volume":"27","author":[{"given":"An","family":"He","sequence":"first","affiliation":[{"name":"Institute of Antibody Engineering School of Biotechnology Southern Medical University Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tian\u2010Cai","family":"Liu","sequence":"additional","affiliation":[{"name":"Institute of Antibody Engineering School of Biotechnology Southern Medical University Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhi\u2010Ning","family":"Dong","sequence":"additional","affiliation":[{"name":"Institute of Antibody Engineering School of Biotechnology Southern Medical University Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhi\u2010Qi","family":"Ren","sequence":"additional","affiliation":[{"name":"Institute of Antibody Engineering School of Biotechnology Southern Medical University Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing\u2010Yuan","family":"Hou","sequence":"additional","affiliation":[{"name":"Institute of Antibody Engineering School of Biotechnology Southern Medical University Guangzhou 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