Patent ID: 7670764

Claim:
A method for diagnosing the presence or severity of liver fibrosis in an individual, the method comprising: (a) determining a level of α2-macroglobulin (α2-MG) in a sample from said individual by contacting said sample with an α2-MG-specific binding agent; (b) determining a level of hyaluronic acid (HA) in a sample from said individual by contacting said sample with an HA-specific binding agent; (c) determining a level of tissue inhibitor of metalloproteinases-1 (TIMP-1) in a sample from said individual by contacting said sample with a TIMP-1-specific binding agent; (d) calculating an index value for the individual using a regression algorithm based upon said level of α2-MG, HA, and TIMP-1, wherein said regression algorithm has a formula: Index Value=Exp( b 0 +b 1 *x 1 +b 2 *x 2 b 3 *x 3 )/(1+Exp( b 0 +b 1 *x 1 +b 2 *x 2 +b 3 *x 3 )), wherein b 0 is an intercept value, wherein said intercept value is based upon the levels of α2-MG, HA, and TIMP-1 in a population of liver fibrosis patients; b 1 is a regression coefficient value for HA, wherein said regression coefficient value is based upon the level of HA in said population of liver fibrosis patients; x 1 is the concentration level of HA; b 2 is a regression coefficient value for TIMP-1, wherein said regression coefficient value is based upon the level of TIMP-1 in said population of liver fibrosis patients; x 2 is the concentration level of TIMP-1; b 3 is a regression coefficient value for α2-MG, wherein said regression coefficient value is based upon the level of α2-MG in said population of liver fibrosis patients; x 3 is the concentration level of α2-MG; and wherein said formula is: Index ⁢ ⁢ Value = Exp [ - 4.3633 + ( 0.0108 ⁢ * ⁢ ⁢ HA ⁢ ⁢ ng ⁢ / ⁢ ml ) + ( 0.0015 ⁢ * ⁢ TIMP ⁢ - ⁢ 1 ⁢ ⁢ ng ⁢ / ⁢ ml ) + ( 0.5357 ⁢ * ⁢ ⁢ α2 ⁢ - ⁢ MG ⁢ ⁢ mg ⁢ / ⁢ ml ) ] 1 + Exp [ - 4.3633 + ( 0.0108 ⁢ * ⁢ HA ⁢ ⁢ ng ⁢ / ⁢ ml ) + ( 0.0015 ⁢ * ⁢ TIMP ⁢ - ⁢ 1 ⁢ ⁢ ng ⁢ / ⁢ ml ) + ( 0.5357 * ⁢ α2 ⁢ - ⁢ MG ⁢ ⁢ mg ⁢ / ⁢ ml ) ] ; (e) comparing the index value calculated for the individual to an index cutoff value, wherein said index cutoff value is between 0.2 and 0.7; and (f) determining the presence or severity of liver fibrosis in said individual based upon whether the index value is above or below the index cutoff value.