Diagnosis and Assessment of Cirrhosis in Non-Alcoholic Steatohepatitis (NASH)

Introduction to Diagnostic Approaches

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, as stated by the American Gastroenterological Association 1, 2

Serum tests like FibroSure are not reliable for diagnosing cirrhosis because several factors not related to fibrosis can contribute to false-positive results, according to the American College of Radiology 3
These tests cannot reliably distinguish between different levels of fibrosis, as noted by the American College of Radiology 3
The American Gastroenterological Association 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

FibroSure/FibroTest is among several proprietary fibrosis biomarkers that have been evaluated for NASH fibrosis assessment, including FIBROSpect NASH, Hepamet Fibrosis Score, Pro-C3 based score, FibroMeter, and Hepascore, as reported by the American Gastroenterological Association 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, according to the American Gastroenterological Association 5

For accurate diagnosis of cirrhosis in NASH, initial risk stratification should use simple non-invasive tests like FIB-4 score, as recommended by the American Gastroenterological Association and the American Association for the Study of Liver Diseases 2, 5
Secondary assessment may include elastography-based tests or proprietary blood tests like FibroSure when initial tests suggest possible advanced fibrosis, as suggested by the American Gastroenterological Association 5
Definitive diagnosis should be made through liver biopsy in patients with high-risk FibroSure results, discordant non-invasive test results, or when definitive staging is needed for treatment decisions, according to the American Association for the Study of Liver Diseases 2

No single non-invasive test has sufficient accuracy to replace liver biopsy for definitive diagnosis of cirrhosis in NASH, as stated by the American Gastroenterological Association and the American Association for the Study of Liver Diseases 2, 4
Several factors not related to fibrosis can contribute to false-positive FibroSure results, highlighting the need for comprehensive assessment, as noted by the American College of Radiology 3
The presence of metabolic syndrome and other risk factors should be considered alongside test results for accurate diagnosis, according to the American Association for the Study of Liver Diseases 2
Different studies use different cutoff values, making standardized interpretation of test results challenging, as reported by the American Association for the Study of Liver Diseases 2