Clinical-liver, pancreas, and biliary tractSerum markers detect the presence of liver fibrosis: A cohort study
Section snippets
Materials and methods
The study and study protocols were approved by the UK South and West Multicentre Research Ethics Committee (MREC 98/6/08) and the local research ethics committees (m140/98) at all participating sites.
We have investigated the relationship among levels of 9 serum fibrosis markers and liver fibrosis assessed by histologic examination of liver biopsy specimens from 1021 prospectively recruited subjects obtained as part of the investigation of chronic liver disease at 13 centers between 1998 and
Results
The primary aim of the study was to investigate the ability of serum markers to identify significant histologic fibrosis. The mean, median, and SEM for each marker in GT and GV were determined. A multivariate analysis of variance indicated that there were no differences between groups for all markers taken together (Hotelling’s T = .01, F = 1.14, df1 = 9, df2 = 911, P = .33). An examination of the associated individual t tests showed no significant differences between the groups on any
Discussion
We have defined an algorithm combining serum markers of liver fibrosis that can be used to exclude significant fibrosis with sensitivity in excess of 90% or to detect significant fibrosis with specificity in excess of 90% by adopting different test thresholds. In addition, the algorithm can detect cirrhosis with sensitivity in excess of 90%. The algorithm achieved a similar level of sensitivity and specificity when compared with the scoring of 3 different pathologists, providing evidence that
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Supported by Bayer Healthcare AG (Leverkusen, Germany). This study is an investigator-initiated study funded by Bayer AG. M.B. and M.V. are employees of Bayer HealthCare AG. R.T. is an independent statistical analyst engaged by Bayer HealthCare AG. A.B., S.H., and T.R. received grant support from Bayer AG.