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<p>Chronic liver disease (CLD) affects millions worldwide, yet accurately staging its progression without liver biopsy remains a major clinical challenge. Human serum albumin (HSA), the most abundant blood protein synthesized exclusively by the liver, undergoes measurable structural modifications as liver disease advances, making it a potential molecular marker of disease severity. Using high-resolution liquid chromatography–mass spectrometry (LC-HR-MS), we quantified native HSA and nine modified isoforms in plasma from 172 CLD patients spanning all fibrosis stages and 82 healthy controls. Native HSA declined markedly with disease severity, reaching 4.1–4.2&#xa0;g/L in decompensated cirrhosis versus 12.2&#xa0;g/L in controls. Modified isoforms showed stage-specific patterns, and their ratios to native HSA amplified the diagnostic signal for advanced disease. A machine learning classifier trained on the full albumin spectral profile achieved substantial agreement with standard staging, and demonstrated higher accuracy than FIB-4 index (81.5% vs. 59.3% accuracy). Within the study cohort, these results were reproduced on two independent instruments from different manufacturers (McNemar <i>p</i> = 0.149), confirming the reproducibility across different platforms of the albumin signature. These findings establish HSA spectral profiling as a promising non-invasive staging tool for CLD, with cross-platform reproducibility supporting its potential for translation to multicenter clinical practice.</p>

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Human serum albumin profiling by top-down analysis enables multi-class liver fibrosis staging: a cross-platform validation study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月18日

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  • Souleiman El Balkhi,
  • Racym Berrah,
  • François Ludovic Sauvage,
  • Léa Le Du,
  • Mohamad Ali Rahali,
  • Roy Lakis,
  • Pierre Marquet,
  • Franck Saint-Marcoux,
  • Véronique Loustaud-Ratti,
  • Paul Carrier

摘要

Chronic liver disease (CLD) affects millions worldwide, yet accurately staging its progression without liver biopsy remains a major clinical challenge. Human serum albumin (HSA), the most abundant blood protein synthesized exclusively by the liver, undergoes measurable structural modifications as liver disease advances, making it a potential molecular marker of disease severity. Using high-resolution liquid chromatography–mass spectrometry (LC-HR-MS), we quantified native HSA and nine modified isoforms in plasma from 172 CLD patients spanning all fibrosis stages and 82 healthy controls. Native HSA declined markedly with disease severity, reaching 4.1–4.2 g/L in decompensated cirrhosis versus 12.2 g/L in controls. Modified isoforms showed stage-specific patterns, and their ratios to native HSA amplified the diagnostic signal for advanced disease. A machine learning classifier trained on the full albumin spectral profile achieved substantial agreement with standard staging, and demonstrated higher accuracy than FIB-4 index (81.5% vs. 59.3% accuracy). Within the study cohort, these results were reproduced on two independent instruments from different manufacturers (McNemar p = 0.149), confirming the reproducibility across different platforms of the albumin signature. These findings establish HSA spectral profiling as a promising non-invasive staging tool for CLD, with cross-platform reproducibility supporting its potential for translation to multicenter clinical practice.