Can FibroSure results alone diagnose liver cirrhosis in non-alcoholic steatohepatitis (NASH)?

FibroSure Alone Cannot Diagnose Liver Cirrhosis in NASH

Liver biopsy remains the gold standard for diagnosing cirrhosis in non-alcoholic steatohepatitis (NASH), and FibroSure alone is not sufficient for definitive diagnosis of cirrhosis. 1, 2

Limitations of Non-Invasive Tests in NASH Cirrhosis Diagnosis

Non-invasive tests (NITs) like FibroSure (also known as FibroTest) have several limitations when used alone for diagnosing cirrhosis in NASH:

• Serum tests like FibroSure are not reliable for diagnosing cirrhosis because several factors not related to fibrosis (such as active hepatitis or Gilbert syndrome) can contribute to false-positive results 3
• These tests cannot reliably distinguish between different levels of fibrosis 3
• The American Gastroenterological Association (AGA) makes no specific recommendation regarding the role of non-invasive tests in the diagnosis of cirrhosis in adults with NAFLD due to knowledge gaps 4

Performance of FibroSure and Other NITs in NASH

While FibroSure and other proprietary fibrosis biomarkers have been studied for NASH fibrosis assessment, their performance has limitations:

• FibroSure/FibroTest is among several proprietary fibrosis biomarkers (along with FIBROSpect NASH, Hepamet Fibrosis Score, Pro-C3 based score, FibroMeter, and Hepascore) that have been evaluated 5
• FIB-4 is recommended as a first-line assessment for practitioners based on its simplicity and low cost, despite not outperforming proprietary tests like FibroSure 5
• In a meta-analysis, even the best-performing non-invasive tests showed limitations in accuracy for diagnosing NASH and fibrosis, with FIB-4 showing an AUC of 0.821 for advanced fibrosis 6

Diagnostic Algorithm for NASH Cirrhosis

For accurate diagnosis of cirrhosis in NASH, follow this approach:

1. Initial risk stratification: Use simple non-invasive tests like FIB-4 score (calculated using age, ALT, AST, and platelet count) as a first-line assessment 5, 2

2. Secondary assessment: If initial tests suggest possible advanced fibrosis:

   • Consider elastography-based tests (VCTE, SWE, or MRE) if available 5
   • Proprietary blood tests like FibroSure may be used as secondary risk assessments when elastography is not available 5

3. Definitive diagnosis: Liver biopsy should be performed in patients with:

   • High-risk FibroSure results suggesting advanced fibrosis
   • Discordant non-invasive test results
   • When definitive staging is needed for treatment decisions 2

Common Pitfalls to Avoid

• Overreliance on a single test: No single non-invasive test has sufficient accuracy to replace liver biopsy for definitive diagnosis of cirrhosis in NASH 4, 2

• Failure to consider confounding factors: Several factors not related to fibrosis can contribute to false-positive FibroSure results 3

• Ignoring clinical context: The presence of metabolic syndrome and other risk factors should be considered alongside test results 2

• Misinterpreting test thresholds: Different studies use different cutoff values, making standardized interpretation challenging 2

In conclusion, while FibroSure and other non-invasive tests are valuable screening tools, they should be used as part of a comprehensive diagnostic approach rather than as standalone tests for diagnosing cirrhosis in NASH patients.