Echosens Fibrometer (Liver Fibrosis, Chronic Viral Hepatitis)

Method Comparison

Comparison between FibroMeter and other non-invasive tests:

Echosens FibroMeter FibroSURE (FibroTest) FibroSpect II
Markers used
  • age, gender
  • ALT
  • alpha-2-macroglobulin
  • gamma-glutamyl transpeptidase (GGT)
  • AST
  • platelet count
  • prothrombin index
  • urea
  • age, gender
  • ALT
  • alpha-2-macroglobulin
  • gamma-glutamyl transpeptidase (GGT)
  • apolipoprotein A1
  • bilirubin
  • haptoglobin
  • alpha-2-macroglobulin
  • Hyaluronic acid
  • Tissue inhibitor of metalloproteinase
Conditions that may affect test¹
  • Non-hepatic inflammation
    • Increased alpha 2-macroglobulin
  • To reduce misclassification, test scores are evaluated by a rule-based algorithm to detect anomalous profile results, which may modify test scores as needed.
  • Non-hepatic inflammation
    • Increased alpha 2-macroglobulin
    • Increased haptoglobin
  • Increased bilirubin
    • Gilbert syndrome
    • Extrahepatic cholestasis
  • Decreased haptoglobin
    • Hemolysis (Side effect of Ribavirin treatment)
  • Severe malnutrition
  • Provides a binary distinction between no/mild and advanced fibrosis; not able to differentiate among each Metavir stage
Turnaround Time 1–5 days 2–5 days 2–5 days
FDA Approval No No No
NY Approval Yes Yes Yes

¹ Stebastiani G et al, 2011

Metavir
Classification
Echosens FibroMeter² FibroSURE (FibroTest)³
≥F2 F4 ≥F2 F4
AUROC 0.85–0.89 0.91 0.74–0.87 0.71–0.87
Sensitivity % 80.5–89.0 94.1 65.0–77.0 50.0–87.0
Specificity % 84.1–89.9 87.6 72.0–91.0 70.0–92.9
PPV % 82.0–86.3 68.0 76.0–80.0 57.9–93.0
NPV % 77.6–82.5 94.7 66.7–81.0 44.0–90.5

² Leroy V et al, 2007 and Cales P et al 2005
³ Leroy V et al, 2007, Sebastiani G et al, 2006, Cales P et al 2005, Imbert-Bismut F et al 2001, and Shaheen AA et al 2007.


Comparison between liver biopsy and the non-invasive FibroMeter test:

FibroMeter Liver Biopsy
Nature of Test Non-invasive Invasive
Advantages Measurement of global fibrosis, suitable for serial observations Direct, evaluation of co-exisiting pathologies
Limitations Indirect measurement of functional changes of the liver Sampling error, inter-observer variability, possible hospitalization
Risks Very little risk Pain, bleeding, pneumothorax, hemothorax, infection
Cost Less expensive than biopsy Expensive
Contradictions None known Uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction, ascites, morbid obesity