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

Objective:Carbohydrate antigen 125(CA125),which is traditionally used in ovarian cancer diagnostics,is increasingly recognized as a marker of congestion and inflammation in heart failure(HF).This study compared the analytical performance of N-(4-aminobutyl)-N-ethylisoluminol(ABEI)-based CA125 and N-terminal pro-Btype natriuretic peptide(NT-proBNP)assays on the Maglumi®X6 analyzer with that of the Roche Cobas e602 system and explored the relationship of CA125 with biomarkers of adverse remodeling in HF with reduced ejection fraction(HFrEF).-Methods:Imprecision testing and method comparison were performed on matched serum samples from 108 HFrEF patients.CA125 concentrations were evaluated in relation to the New York Heart Association(NYHA)class,left ventricular ejection fraction(LVEF),galectin-3,and soluble suppression of tumorigenicity 2(sST2)levels.Prognostic value was assessed by Kaplan-Meier survival analysis using the 35 U/mL threshold.Results:The ABEI based CA125 assay showed low imprecision[coefficient of variation(CV)≤4.5%]and strong agreement with the Cobas e602 assay(R=0.97,slope=1.06,P<0.001).CA125 levels increased progressively with NYHA class(P=0.02),correlated negatively with LVEF(R=-0.38,P<0.001)and positively with galectin-3(R=0.21,P=0.03)and sST2(R=0.57,P<0.001).Elevated CA125 levels(≥35 U/mL)were associated with significantly increased cardiovascular mortality(P<0.001).Conclusions:ABEI-based CA125 measurement provides an analytical performance comparable to that of Cobas e602.In HFrEF,CA125 is correlated with clinical severity,fibrosis/inflammation biomarkers,and prognosis.Its integration into multimarker strategies,particularly alongside NT-proBNP and sST2,may enhance risk stratification and therapeutic monitoring,including the response to sodium-glucose cotransporter-2(SGLT2)inhibitor therapy.