Assessment of FIBROSpect II to detect hepatic fibrosis in chronic hepatitis C patients

Am J Med. 2007 Mar;120(3):280.e9-14. doi: 10.1016/j.amjmed.2006.06.044.


Background: The degree of liver fibrosis in patients with Hepatitis C (HCV) provides important prognostic information; however, the only current method available to obtain this information is by performing a liver biopsy. Liver biopsies are invasive, associated with complications, and costly. There has been recent interest in developing a panel of serum markers that can reliably predict the presence of fibrosis and, thus, obviate the need for a liver biopsy. Our objective was to prospectively validate a panel of serum fibrosis markers (FIBROSpect(SM) II) that has been recently developed.

Methods: Serum was obtained from 108 consecutive HCV (15% with HCV/ETOH) patients seen in a hepatology clinic at a single tertiary care center at the time of liver biopsy. The performance of FIBROSpect II (consisting of 3 fibrosis markers: hyaluronic acid, tissue inhibitor of metalloproteinases 1, and alpha-2-macroglobulin) in differentiating mild (F0-F1) from significant (F2-F4) fibrosis was assessed by comparing the panel results with performed liver biopsy.

Results: The prevalence of significant fibrosis in the study group was 36.1%. The diagnostic value of the serum marker panel to detect significant fibrosis as assessed by area under the receiver operating characteristic (ROC) curve was 0.826. Performance characteristics are as follows: sensitivity 71.8%, specificity 73.9%, positive predictive value 60.9%, negative predictive value 82.3%, and overall accuracy of 73.1%.

Conclusion: This prospective study supports the clinical utility of serum markers in detecting fibrosis and validates the performance of FIBROSpect II in a prospective cohort of patients. The high negative predictive value of the test provides a reliable alternative to rule out severe fibrosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Algorithms
  • Ambulatory Care
  • Biomarkers / blood
  • Biopsy, Needle
  • Confidence Intervals
  • Disease Progression
  • Female
  • Hepatitis C, Chronic / complications*
  • Hepatitis C, Chronic / diagnosis
  • Humans
  • Hyaluronic Acid / analysis
  • Hyaluronic Acid / blood*
  • Immunohistochemistry
  • Liver Cirrhosis / blood*
  • Liver Cirrhosis / etiology
  • Liver Cirrhosis / pathology*
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Probability
  • Prospective Studies
  • Sensitivity and Specificity
  • Severity of Illness Index
  • Tissue Inhibitor of Metalloproteinase-1 / analysis
  • Tissue Inhibitor of Metalloproteinase-1 / blood*
  • alpha-Macroglobulins / analysis*


  • Biomarkers
  • Tissue Inhibitor of Metalloproteinase-1
  • alpha-Macroglobulins
  • Hyaluronic Acid