The inventors have proposed a novel panel of
human plasma protein biomarkers for diagnosing
hepatic fibrosis and
cirrhosis. Presently there is no reliable non-invasive way of assessing
liver fibrosis. A 2D-PAGE based
proteomics study was used to identify potential
fibrosis biomarkers.
Plasma from patients with hepatic
cirrhosis induced by infection with the
hepatitis C
virus (HCV) were analysed. Several proteins associated with liver scarring and potentially also related to
viral infection were identified. These proteins include 14-3-3
protein zeta /
delta,
adiponectin, afamin, alpha-1-antitrypsin, alpha-2-HS-
glycoprotein, apolipoprotein C-III, apolipoprotein E, C4b-
binding protein beta chain, intact / cleaved complement C3dg,
corticosteroid-binding
globulin,
fibrinogen gamma chain, beta
haptoglobin at pH 5.46-5.49,
haptoglobin-related
protein, hemopexin, immunoglobulin J chain,
leucine-rich alpha-2-
glycoprotein, lipid transfer
inhibitor protein,
retinol-
binding protein 4, serum
paraoxonase / arylesterase 1, sex
hormone-binding
globulin and
zinc-alpha-2-
glycoprotein. These biomarkers can be used in conjunction with polypeptides in WO / 2008 / 031051. The concentrations of these novel biomarkers can be determined using an
immunoassay where the concentrations would reflect the extent of
fibrosis. A
fibrosis scoring scale for each of the novel biomarkers is proposed. The additive result from the scores of all the novel biomarkers would give a more reliable indication of the degree of fibrosis rather than examining individual biomarkers.