Introduction: Noninvasive tests (NITs) have become central to the diagnosis and staging of metabolic dysfunction–associated steatotic liver disease (MASLD), reducing reliance on liver biopsy. However, most validation studies have been performed in selected populations, and it is uncertain whether these tools perform consistently across different geographic regions.
Introduction:
Noninvasive tests (NITs) have become central to the diagnosis and staging of metabolic dysfunction–associated steatotic liver disease (MASLD), reducing reliance on liver biopsy. However, most validation studies have been performed in selected populations, and it is uncertain whether these tools perform consistently across different geographic regions. The Global MASLD (G-MASLD) study evaluated the worldwide performance of commonly used NITs in biopsy-confirmed MASLD.
Why was this study needed?
. MASLD is a global disease with marked regional differences in patient characteristics.
. Most fibrosis scores have been validated in limited geographic populations.
. Understanding regional variation is essential for appropriate interpretation of NITs.
. Identifying the most reliable noninvasive tests can improve global screening and risk stratification.
Results:
This multinational analysis included nearly 18,000 patients with biopsy-confirmed MASLD from 41 countries, making it one of the largest global evaluations of noninvasive fibrosis assessment. The diagnostic performance of FIB-4, Enhanced Liver Fibrosis (ELF), and liver stiffness measurement (LSM) varied across geographic regions, reflecting differences in population characteristics and disease profiles. In contrast, the composite algorithms Agile-3+ for advanced fibrosis and Agile-4 for cirrhosis demonstrated consistently high diagnostic accuracy across most regions and outperformed many conventional NITs. Liver stiffness measurement also maintained good overall performance despite modest regional variability, whereas FIB-4 and ELF showed greater fluctuations in diagnostic accuracy.
Clinical Impact:
These findings suggest that clinicians should recognize regional differences when interpreting traditional fibrosis scores such as FIB-4 and ELF. Composite algorithms incorporating transient elastography, particularly Agile-3+ and Agile-4, provide more robust and consistent fibrosis assessment across diverse populations and may be preferable for international clinical practice and multicenter clinical trials.
Bottom Line:
The diagnostic performance of noninvasive fibrosis tests varies globally in MASLD, but Agile-3+ and Agile-4 consistently demonstrate the highest accuracy, supporting their use as preferred tools for fibrosis and cirrhosis risk stratification across diverse populations.
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