title: Assessment of FIBROSpect II to detect hepatic fibrosis in chronic hepatitis C patients.
abstract: 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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland, Oregon 97201, USA. zamana@ohsu.edu
authors.forename: Atif
authors.initials: A
authors.lastname: Zaman
authors.forename: Hugo R
authors.initials: HR
authors.lastname: Rosen
authors.forename: Ken
authors.initials: K
authors.lastname: Ingram
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Corless
authors.forename: Esther
authors.initials: E
authors.lastname: Oh
authors.forename: Katie
authors.initials: K
authors.lastname: Smith
mesh_terms: D000328:Adult; D000465:Algorithms; D000553:Ambulatory Care; D015415:Biomarkers / Q000097:blood; D001707:Biopsy, Needle; D016001:Confidence Intervals; D018450:Disease Progression; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000175:diagnosis; D006801:Humans; D006820:Hyaluronic Acid / Q000032:analysis / Q000097:blood*; D007150:Immunohistochemistry; D008103:Liver Cirrhosis / Q000097:blood* / Q000209:etiology / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011336:Probability; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D019715:Tissue Inhibitor of Metalloproteinase-1 / Q000032:analysis / Q000097:blood*; D000511:alpha-Macroglobulins / Q000032:analysis*
chemical_list: D015415:Biomarkers; D019715:Tissue Inhibitor of Metalloproteinase-1; D000511:alpha-Macroglobulins; D006820:Hyaluronic Acid