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Elafin is a promising biomarker, yet no high\u2010throughput clinical assay exists. A chemiluminescence immunoassay (CLIA) reagent kit for plasma Elafin has been developed and validated using automated analyzers to enable rapid diagnosis, objective severity stratification, and longitudinal monitoring. Analytical performance is rigorously assessed, including the limit of blank (LoB) (0.069\u00a0ng\u00a0mL\n                    <jats:sup>\u22121<\/jats:sup>\n                    ), limit of detection (LoD) (0.099\u00a0ng\u00a0mL\n                    <jats:sup>\u22121<\/jats:sup>\n                    ), limit of quantification (LoQ) (0.8\u00a0ng\u00a0mL\n                    <jats:sup>\u22121<\/jats:sup>\n                    ), linearity (0.8\u2013200\u00a0ng\u00a0mL\n                    <jats:sup>\u22121<\/jats:sup>\n                    ), precision, recovery, reproducibility, and interference resistance. Plasma Elafin is quantified in 731 participants from five hospitals: 112 healthy controls, 466 psoriasis patients (mild = 164, moderate = 158, severe = 144), and 153 disease controls. The assay achieves 89% diagnostic accuracy with an area under the receiver operating characteristic curve (AUC) of 0.94 for psoriasis. It effectively distinguishes disease severity (AUC 0.68 mild vs moderate; 0.77 moderate vs severe), and Elafin levels correlated with treatment duration in moderate (R = 0.51) and severe (R = 0.41) cases. This CLIA reagent kit demonstrates excellent analytical and clinical performance, supporting automated, high\u2010throughput Elafin detection as a reliable tool for diagnosing and managing moderate\u2010to\u2010severe psoriasis.\n                  <\/jats:p>","DOI":"10.1002\/advs.202511535","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T03:50:26Z","timestamp":1759290626000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Multicenter Validation of a Fully Automated Chemiluminescence Immunoassay for Plasma Elafin in Psoriasis Diagnosis and Severity Assessment"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0675-8456","authenticated-orcid":false,"given":"Jingkun","family":"Yi","sequence":"first","affiliation":[{"name":"State Key Laboratory of Medical Proteomics Beijing Proteome Research Center National Center for Protein Sciences\u2010Beijing (PHOENIX Center) Beijing Institute of Lifeomics  Beijing 102206 China"},{"name":"Department of Biomedical Informatics State Key Laboratory of Vascular Homeostasis and Remodeling School of Basic Medical Sciences Peking University  Beijing 100191 China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng","family":"Xu","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Medical Proteomics Beijing Proteome Research Center National Center for Protein Sciences\u2010Beijing (PHOENIX Center) Beijing Institute of Lifeomics  Beijing 102206 China"},{"name":"Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University  Zhengzhou Henan 450052 China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Han","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine  Guangzhou Guangdong 510000 China"},{"name":"Chinese Medicine Guangdong Laboratory  Hengqin Guangdong 519000 China"},{"name":"State Key Laboratory of Dampness Syndrome of Chinese Medicine The Second Affiliated Hospital of Guangzhou University of Chinese Medicine  Guangzhou Guangdong 510120 China"},{"name":"Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome  Guangzhou Guangdong 510000 China"},{"name":"Guangdong\u2010Hong Kong\u2010Macau Joint Lab on Chinese Medicine and Immune Disease Research Guangzhou University of Chinese Medicine  Guangzhou Guangdong 510120 China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhining","family":"Dong","sequence":"additional","affiliation":[{"name":"Guangzhou DARUl Biotechnology Co. 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