What is the FibroSure test?

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Last updated: September 27, 2026 • View editorial policy

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What is the FibroSure Test?

FibroSure (marketed as FibroTest outside the USA) is a patented, commercially available blood test that combines multiple serum biomarkers into a proprietary algorithm to non-invasively assess liver fibrosis stage, serving as an alternative to liver biopsy. 1

Test Components and Methodology

FibroSure uses a proprietary formula developed by Biopredictive (Paris, France) and licensed as FibroSure in the USA through LabCorp. The algorithm combines the following serum parameters 1:

  • α-2-macroglobulin
  • Haptoglobin
  • Apolipoprotein A1
  • Total bilirubin
  • Gamma-glutamyl transferase (GGT)
  • Age
  • Gender

The test generates a quantitative score that correlates with histological fibrosis stages (typically using the METAVIR scoring system).

Clinical Applications

FibroSure was originally developed and validated for chronic hepatitis C (HCV) but has been studied across multiple liver diseases including 1:

  • Hepatitis B virus (HBV) infection
  • HIV-HCV coinfection
  • Non-alcoholic fatty liver disease (NAFLD)
  • Autoimmune hepatitis (AIH) 2
  • Monitoring patients on hepatotoxic medications like methotrexate 3

Performance Characteristics

Advantages 1:

  • High applicability (>95%) - can be performed on nearly all patients
  • Good inter-laboratory reproducibility
  • High performance for detecting cirrhosis (AUROC >0.9)
  • Non-invasive and can be repeated frequently for monitoring

Limitations 1:

Critical pitfalls to avoid:

  • Not liver-specific - results influenced by systemic conditions affecting individual biomarkers
  • False positives occur with:
    • Hemolysis (decreases haptoglobin)
    • Gilbert syndrome (increases bilirubin)
    • Acute hepatitis (elevates liver enzymes)
    • Rheumatoid arthritis or chronic inflammation (increases α-2-macroglobulin)
  • Unable to discriminate between intermediate fibrosis stages (F1 vs F2)
  • Suboptimal accuracy for significant fibrosis in hepatitis B (sensitivity 61%, specificity 80% at threshold 0.48) 4
  • Not recommended for fibrosis staging in primary biliary cholangitis (PBC) per current guidelines 5

Diagnostic Accuracy

For chronic hepatitis B, meta-analysis shows 4:

  • Significant fibrosis (≥F2): AUROC 0.84, sensitivity 61%, specificity 80%
  • Cirrhosis: AUROC 0.87, sensitivity 62%, specificity 91%

For autoimmune hepatitis 2:

  • Significant fibrosis (≥F2): AUROC 0.83
  • Comparable performance to transient elastography
  • Superior to FIB-4 index

Companion Test: ActiTest

FibroSure is often paired with ActiTest, which uses similar biomarkers to assess necroinflammatory activity rather than fibrosis, providing complementary information about disease activity 6, 2.

Clinical Context

While FibroSure represents one of the first commercially available serum biomarker panels for liver fibrosis assessment, current guidelines favor liver stiffness measurement by transient elastography over serum biomarkers for most chronic liver diseases, particularly in conditions like PBC and PSC 5. However, FibroSure remains valuable when elastography is unavailable or contraindicated, and for longitudinal monitoring where repeated testing is needed 7.

References

6
Research

FibroTest-FibroSURE: towards a universal biomarker of liver fibrosis?

Expert review of molecular diagnostics, 2005

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