FAST and Agile-the MASLD drift: Validation of Agile 3+, Agile 4 and FAST scores in 246 biopsy-proven NAFLD patients meeting MASLD criteria of prevalent caucasian origin

PLoS One. 2024 May 23;19(5):e0303971. doi: 10.1371/journal.pone.0303971. eCollection 2024.

Abstract

Background: MASLD is a prevalent chronic liver condition with substantial clinical implications. This study aimed to assess the effectiveness of three new, elastography-based, scoring systems for advanced fibrosis ≥F3 (Agile 3+), cirrhosis F4 (Agile 4), and fibrotic NASH: NASH + NAS ≥4 + F≥2 (FAST score), in a cohort of biopsy-proven NAFLD meeting MASLD criteria. Our secondary aim was to compare their diagnostic performances with those of other fibrosis prediction tools: LSM-VCTE alone, and common, easily available scores (FIB-4 or APRI).

Methods: Single-center, retrospective study, on consecutive patients with baseline laboratory tests, liver biopsy, and reliable LSM-VCTE measurements. The discrimination between tests was evaluated by analyzing the AUROCs. Dual cut-off approaches were applied to rule-out and rule-in ≥F3, F4 and fibrotic NASH. We tested previously reported cut-off values and provided our best thresholds to achieve Se ≥85%, Se ≥90%, and Sp ≥90%, Sp ≥95%.

Results: Among 246 patients, 113 (45.9%) were women, and 75 (30.5%) presented diabetes. Agile 3+ and Agile 4 demonstrated excellent performance in identifying ≥F3 and F4, achieving AUROCs of 0.909 and 0.968, while the FAST score yielded acceptable results in distinguishing fibrotic NASH. When compared to FIB-4 and LSM-VCTE, both Agile 3+ and Agile 4 performed better than FIB-4 and had a similar performance to LSM-VCTE, but with higher diagnostic accuracy, hence reducing the grey zone.

Conclusion: Agile 3+ and Agile 4 are reliable, non-invasive tests for identifying advanced fibrosis or cirrhosis in MASLD patients, while FAST score demonstrates moderate performance in identifying fibrotic NASH.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Biopsy / methods
  • Elasticity Imaging Techniques* / methods
  • Female
  • Humans
  • Liver / pathology
  • Liver Cirrhosis* / diagnosis
  • Liver Cirrhosis* / pathology
  • Male
  • Middle Aged
  • Non-alcoholic Fatty Liver Disease* / diagnosis
  • Non-alcoholic Fatty Liver Disease* / pathology
  • Retrospective Studies
  • Severity of Illness Index

Grants and funding

This work was partially funded from the grants number PN-III-P4-PCE-2021-1140 from UEFISCDI, the Romanian Executive Agency for Higher Education, Research, Development, and Innovation Funding and 35167/17.12.2021 from the University of Medicine and Pharmacy “Iuliu Hațieganu” Cluj-Napoca. Madalina-Gabriela Taru is financed by The Study Loans and Scholarships Agency, The Ministry of Education, Romania.