Assessment of liver fibrosis scoring with serum marker algorithms
View Patent ↗The present invention concerns a method for diagnosing liver fibrosis wherein two or more diagnostic markers are measured and the measurements are correlated by a mathematic algorithm characterized in that the diagnostic markers are selected from the group N-terminal procollagen III propeptide (PIIINP), Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1 and MMP-9/TIMP-1 complex. The algorithm can be used to predict the histological score of a liver biopsy.
1. A method for aiding in the diagnosis of liver fibrosis comprising:
(a) obtaining a sample of body fluid from an individual;
(b) selecting two or more diagnostic markers from the group consisting of: PIIINP, Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1 and MMP-9/TIMP-1 complex;
(c) measuring the amount of each said selected two or more diagnostic markers in said sample to obtain a measured value for each of said selected diagnostic markers; and
(d) combining said measured value of each said selected diagnostic markers using a mathematical algorithm to obtain a liver fibrosis score.
2. The method according to claim 1 wherein said sample of body fluid is blood, serum, plasma or urine.
3. The method according to claim 1 wherein said liver fibrosis score is used to support, predict or substitute the histological score of a liver biopsy.
4. The method according to claim 1 wherein said mathematical algorithm is a discriminant function algorithm.
5. The method according to claim 4 wherein said discriminant function algorithm is a linear discriminant function algorithm.
6. The method according to claim 4 wherein said liver fibrosis score corresponds to a pathology score obtained by a histological assessment of a liver biopsy.
7. The method according to claim 6 wherein said pathology score is obtained by using any one of the following scoring systems: the Scheuer scoring system, the Ishak scoring system, the HAI scoring system, the Ludwig scoring system, or the Metavir scoring system.
8. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to determine a treatment strategy for said individual.
9. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to monitor the efficacy of an implemented treatment strategy for said individual.
10. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to determine whether said individual should obtain a liver biopsy.
11. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to distinguish liver fibrosis from liver cirrhosis.
12. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to evaluate the degree of liver fibrosis in said individual.
13. The method according to claim 1 wherein said selected diagnostic markers includes at least one of Hyaluronan, PIIINP or TIMP-1.
14. The method according to claim 1 wherein said selected diagnostic markers includes at least two of Hyaluronan, PIIINP or TIMP-1.
15. The method according to claim 1 wherein said selected diagnostic markers includes Hyaluronan, PIIINP and TIMP-1.
16. The method according to claim 3 wherein said body fluid is blood, serum, plasma or urine.
17. The method according to claim 3 wherein said liver fibrosis score is used to support, predict or substitute the histological score of a liver biopsy.
18. The method according to claim 3 wherein said liver fibrosis score is at least one factor used to determine a treatment strategy for said individual.
19. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to monitor the efficacy of an implemented treatment strategy for said individual.