Analytical and clinical evaluation of ABEI-based CA125 immunoassays in heart failure: method comparison, biomarker profiles and prognostic insights

Traditionally used for ovarian cancer diagnosis, carbohydrate antigen 125 (CA125) has recently been recognized as having significant value in the field of heart failure (HF), emerging as a novel biomarker reflecting congestion and inflammation. The latest study systematically evaluated the analytical performance and clinical application potential of the ABEI-based chemiluminescence CA125 detection method in heart failure with reduced ejection fraction (HFrEF).

The study validated that the ABEI-based CA125 detection method demonstrated excellent imprecision (CV≤ 4.5%) on the Maglumi® X6 platform and high consistency with the Roche Cobas e602 system. In a cohort of 108 HFrEF patients, CA125 levels were positively correlated with cardiac function classification, negatively correlated with left ventricular ejection fraction, and significantly associated with the inflammation/fibrosis biomarker sST2. Survival analysis revealed that patients with CA125 ≥35 U/mL had a significantly higher risk of cardiovascular death.

The innovation of this study lies in its first systematic validation of the analytical reliability of this detection method in heart failure and its clarification of the association with inflammatory/fibrotic processes. The ABEI non-enzymatic chemiluminescence technology offers stable signals and rapid detection, making it suitable for clinical application. More importantly, this study provides solid evidence for CA125 as an auxiliary biomarker in heart failure, supporting its combined use with biomarkers such as NT-proBNP and sST2 to improve risk stratification accuracy and optimize treatment monitoring. It particularly demonstrates promising application prospects in the efficacy evaluation of SGLT2 inhibitors, offering new insights for multi-biomarker management strategies in heart failure.