ECM1 as a biomarker for liver disease: Development of an ELISA and analysis of human serum levels

Extracellular Matrix Protein 1 (ECM1) is an 85 kDa glycoprotein that is a component of the extracellular matrix, particularly in the liver and other organs. It has been identified to perform various physiological functions and plays a crucial role in liver fibrogenesis and the progression of cirrhosis (Fan et al., 2019).

While ultrasonography, computed tomography (CT) and magnetic resonance imaging (MRI) are commonly used for diagnosing liver cirrhosis, no known specific peripheral blood biomarker currently exists for the diagnosis of acute and chronic liver diseases (Shuppan and Afdhal, 2008) (Lurie et al., 2015).

The aim of this study was the assessment of ECM1 protein concentration in human serum samples to determine its role under different physiological or pathological conditions and to evaluate its potential as a biomarker. To achieve this, an enzyme-linked immunosorbent assay (ELISA) was developed for the quantification of ECM1 in human serum.

The assay’s precision was confirmed through strong parallelism, and recovery was shown to be within the accepted range using spiked samples.

Reproducibility and consistency were further validated by assessing intra- and interassay variation, with the ECM1 ELISA yielding reliable and accurate results.

A total of 35 patients with liver fibrosis, 50 with autoimmune hepatitis (AIH), 144 with liver cirrhosis and 141 with hepatocellular carcinoma (HCC) were included in the study. Results were compared to 84 healthy controls. No significant differences in ECM1 levels were observed in patients with mild stages of liver disease, such as fibrosis; notably, AIH patients even exhibited reduced ECM1 concentrations. In contrast, patients with advanced liver conditions, including cirrhosis and HCC, demonstrated significantly elevated ECM1 levels.

For liver cirrhosis the optimal diagnostic cutoff value was 2.79 ug/mL, yielding a sensitivity 62.3%, specificity of 61.9%, positive predictive value (PPV) of 43.2% and a negative predictive value (NPV) of 78%.

For HCC the cutoff value was at 2.73 ug/mL, with a sensitivity of 54.6%, a specificity of 54.8%, PPV of 35.2% and NPV 72.8%.

The area under the receiver operating characteristic curve (AUC) was 0.668 for liver cirrhosis and 0.584 for HCC.

In conclusion, ECM1 may serve as a potential biomarker in peripheral blood for the detection and monitoring of severe and progressive liver diseases, however additional studies are warranted to validate its diagnostic and prognostic value.

 

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Publication History

Article published online:
04 September 2025