DataVXAdvanced SciencePaper
journal article·2025-12Open access

A Multicenter Validation of a Fully Automated Chemiluminescence Immunoassay for Plasma Elafin in Psoriasis Diagnosis and Severity Assessment

Jingkun Yi, Meng Xu, Ling Han, Zhining Dong, Ruimin Liu, Xiaomei Zhang, Di Hu, Chuanjian Lu, Xiaobo Yu

Advanced Science· Volume 12· Issue 47
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Source abstract

Abstract

Abstract Psoriasis diagnosis and severity assessment rely on subjective skin evaluations. Elafin is a promising biomarker, yet no high‐throughput 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 ng mL −1 ), limit of detection (LoD) (0.099 ng mL −1 ), limit of quantification (LoQ) (0.8 ng mL −1 ), linearity (0.8–200 ng mL −1 ), 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‐throughput Elafin detection as a reliable tool for diagnosing and managing moderate‐to‐severe psoriasis.
Source: crossref · Quality: baseline

Research context

OpenAlex topics: Psoriasis: Treatment and Pathogenesis · Asthma and respiratory diseases · Allergic Rhinitis and Sensitization

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

State Key Laboratory of Medical Proteomics Beijing Proteome Research Center National Center for Protein Sciences‐Beijing (PHOENIX Center) Beijing Institute of Lifeomics Beijing 102206 China

Department of Biomedical Informatics State Key Laboratory of Vascular Homeostasis and Remodeling School of Basic Medical Sciences Peking University Beijing 100191 China

Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan 450052 China

The Second Clinical College of Guangzhou University of Chinese Medicine Guangzhou Guangdong 510000 China

Chinese Medicine Guangdong Laboratory Hengqin Guangdong 519000 China

State Key Laboratory of Dampness Syndrome of Chinese Medicine The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong 510120 China

Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome Guangzhou Guangdong 510000 China

Guangdong‐Hong Kong‐Macau Joint Lab on Chinese Medicine and Immune Disease Research Guangzhou University of Chinese Medicine Guangzhou Guangdong 510120 China

Guangzhou DARUl Biotechnology Co. Ltd Guangzhou Guangdong 510000 China

Hebei University Baoding Hebei 071002 China

ProteomicsEra Medical Co., Ltd Beijing 102206 China

State Key Laboratory of Traditional Chinese Medicine Syndrome the Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong 510120 China

School of Basic Medicine Sciences, Anhui Medical University, Hefei, Anhui, PR China. Hefei Anhui 230032 China

Basic Medical College Qingdao University Qingdao 266071 China

International Academy of Phronesis Medicine (Guangdong) Guangzhou 510320 China

Funding

National Key Research and Development Program of China · Natural Science Foundation of Beijing Municipality

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