AJM Theme Issue: GastroenterologyAJM online: Clinical research studyAssessment of FIBROSpect II to Detect Hepatic Fibrosis in Chronic Hepatitis C Patients
Section snippets
Study Subjects
Consecutive patients with hepatitis C seen in the hepatology clinic at Oregon Health and Science University were asked to participate in this study. All patients were anti-HCV (hepatitis C) positive and had detectable plasma HCV-RNA by polymerase chain reaction. The study was approved by the Institutional Review Board at Oregon Health and Science University. The period of enrollment was between October 2001 and June 2003. All patients at the time of liver biopsy underwent a blood draw for a
Results
One hundred eight consecutive hepatitis C patients seen at the Oregon Health and Science University Hepatology Clinic were enrolled in this prospective validation study. Demographic and baseline characteristics are summarized in Table 1. The mean age of the cohort was 44 ± 7.9 years with a male predominance (65%). Fifteen percent (15%) of the cohort also had a physician-reported diagnosis of alcohol-related liver disease. The mean ALT was 81 IU/L (range 16-519) and mean AST IU/L was 59 (range
Discussion
The current study validates the performance characteristics of the FIBROSpect II assay using a US cohort of HCV patients. Serum was collected prospectively at the time of liver biopsy. The overall performance of the diagnostic test was very good based upon the area under the ROC curve (a value of 0.826). Negative and positive predictive values were good to very good, depending upon the baseline prevalence of significant fibrosis (F2-F4) of the population. In general, the lower the baseline
References (13)
Antifibrotic therapy in chronic liver disease
Clin Gastroenterol Hepatol
(2005)- et al.
Histological grading and staging of chronic hepatitis
J Hepatol
(1995) - et al.
An algorithm for the grading of activity in chroinic hepatitis C
Hepatology
(1996) - et al.
Ultrasound assisted percutaneous liver biopsy: superiority of the Trucut over the Menghini needle for the diagnosis of cirrhosis
Gastroenterology
(1988) - et al.
The role of laparoscopy in the diagnosis of cirrhosis
Gastrointest Endosc
(1996) - et al.
Evaluation of a panel of non-invasive serum markers to differentiate mild from moderate-to-advanced liver fibrosis in chronic hepatitis C patients
J Hepatol
(2004)
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2013, Advances in Clinical ChemistryCitation Excerpt :The assay predicted mild and advanced fibrosis but performed less well for intermediate stages. The assay has been prospectively validated and the high NPV provides a reliable alternative to rule out advanced fibrosis [114,115]. Using a multicenter cohort of 1021 patients with CHC, NAFLD, and ALD, the European Liver Fibrosis group developed an algorithm that included HA, PIIINP, and TIMP-1 [116].
Funding for this study was given by Prometheus Laboratories, which included only the cost of serum fibrosis testing, shipping and handling costs, and statistical support. No other financial support was given.