摘要
BACKGROUND Metabolic dysfunction-associated steatotic liver disease(MASLD),hepatic fibrosis,and cirrhosis are major risk factors for hepatocellular carcinoma(HCC),yet current blood-based diagnostic assays lack sufficient accuracy for routine clinical use.Identifying a non-invasive molecular signature that accurately detects liver disease could improve early diagnosis and monitoring.We hypothesized that the Liver FibraChek Dx■serum assay could discriminate MASLD and HCC from healthy controls using a multiplex biomarker-based algorithm.AIM To evaluate the diagnostic performance of the Liver FibraChek Dx■assay for detecting MASLD and HCC.METHODS This was a prospective,single-center study conducted in a United States tertiary care setting.Serum samples were collected from 45 participants(14 MASLD,19 HCC,12 healthy controls)with liver histology confirmed by biopsy.The Liver FibraChek Dx■algorithm integrates weighted values of aspartate aminotransferase,alanine aminotransferase,taurocholic acid,L-tyrosine,platelet count,and patient age to generate a risk score.Wilcoxon rank sum tests were used to assess associations with histologic diagnosis,and receiver operating characteristic(ROC)curves quantified diagnostic performance.RESULTS Liver FibraChek Dx■risk scores were significantly elevated in MASLD and HCC compared to controls(median:6.92±3.86 vs 3.61±1.67,P<0.001).The area under the ROC curve was 0.890(95%CI:0.776-1.000)for distinguishing diseased from healthy individuals.Sensitivity was 93.9%,specificity 75.0%,positive predictive value 91.1%,negative predictive value 81.8%,and overall accuracy 88.9%.CONCLUSION The Liver FibraChek Dx■assay accurately detects liver disease and shows promise as a non-invasive tool for diagnosing and monitoring MASLD and HCC.
