Arka De, Ajay Duseja, Manu Mehta, Shivaram P Singh, Shalimar, Shrikant Mukewar, Sourabh Mukewar, Sanjib Kar, Omesh Goyal, Jayanthi Venkataraman, Krishnadas Devadas, Vinod K Dixit, Varun Mehta, Rakhi Maiwal, Piyush Ranjan, Aabha Nagral, Narendra S Choudhary, Anil Arora, Dibyalochan Praharaj, Brij Sharma, Arun Valsan, Sunil Dadhich, Sandeep Nijhawan, Akash Roy, Padaki N Rao, Akash Shukla, Pankaj Asati, Rohit Gupta, Sanjeev Saigal, Krishnasamy Narayanasamy, Rajiv Mehta, Mallika Bhattacharya, V G Mohan Prasad, Abraham Koshy, Mukul Rastogi, Seema Alam, Arun J Sanyal, ICON-D Study group
The AGILE scores have comparable AUC as LSM for detecting advanced fibrosis or cirrhosis with a significantly smaller grey zone. Combined sequential use of LSM followed by the AGILE scores improves sensitivity without compromising specificity or the grey zone.
BACKGROUND/AIMS: Despite their high sensitivity, common non-invasive tests (NITs) have relatively lower specificity and are more suited for ruling out advanced fibrosis (F ≥ 3) and cirrhosis (F4). AGILE 3+ and AGILE 4 scores are novel NITs designed to have high specificity for ruling-in advanced fibrosis and cirrhosis, respectively, and reduce the associated grey zone. We validated AGILE 3+ and AGILE 4 in Indian patients with non-alcoholic fatty liver disease (NAFLD) and compared the discriminatory ability, diagnostic performance, and grey zone of AGILE scores with other common NITs.
METHODS: Data of all NAFLD patients with liver biopsy (n = 381, males: 63.7%, age: 42 [33-50] years) recruited across 35 centres over 4 years (n = 8043) were analysed.
RESULTS: AGILE 3+ had sensitivity and specificity of 70% and 89.4%, respectively, with an area under the curve (AUC) of 0.78 (0.74-0.83) for F ≥ 3 which was significantly better than AST-platelet ratio index (APRI), NAFLD Fibrosis Score (NFS), and Fibrosis-4 (FIB-4) but not liver stiffness measurement (LSM). The AUC of AGILE 4 (0.82 (0.77-0.85]) for F4 was significantly better than APRI and NFS but not FIB-4 or LSM, with a sensitivity and specificity of 69.2% and 94.7%, respectively. The proportion of patients falling in the grey zone with AGILE 3+ (12.07%) and AGILE 4 (14.2%) were significantly less than that with APRI, FIB-4, NFS, and LSM. Combined sequential approach using LSM followed by AGILE 3+ had a sensitivity and specificity of 80% and 89.4%, respectively, for F ≥ 3, with a grey zone of 9.1%. Combined sequential approach using LSM followed by AGILE 4 had a sensitivity and specificity of 81.8% and 95%, respectively, for F4, with a grey zone of 12.6%.
CONCLUSION: The AGILE scores have comparable AUC as LSM for detecting advanced fibrosis or cirrhosis with a significantly smaller grey zone. Combined sequential use of LSM followed by the AGILE scores improves sensitivity without compromising specificity or the grey zone.