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

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

SUBMITTER: Yi J 

PROVIDER: S-EPMC12713042 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature