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Liver fibrosis is a major predictor of chronic liver disease progression and liver-related mortality, irrespective of the etiology. Hepatic fibrosis has traditionally been diagnosed and staged by liver biopsy (1). Several limitations of the routine use of liver biopsies have been identified, including sampling error, interand intra-observer variability, and complications leading to morbidity, along with low tolerability. Consequently, liver biopsy has been accepted as an “imperfect gold standard” by many experts (2,3). The implementation of non-invasive approaches, including biomarkers, scoring systems, and imaging techniques, for the assessment of liver fibrosis evolved rapidly to yield several scoring systems (e.g., AAR, BARD, APRI, FIB-4, and NAFLD fibrosis score) and commercial non-invasive tests (e.g., the Enhanced Liver Fibrosis score and Fibrotest®) (4). Reportedly, many of these tests result in high specificity and negative predictive values and have frequently been used to rule out significant fibrosis and cirrhosis prior to liver biopsies. Original and validation studies have observed diagnostic accuracy in the determination of significant fibrosis with area under the receiver operating characteristic curve levels of 74%–88% (5). However, most tests have much more limited precision in the detection of intermediate levels of fibrosis (6). Further research in the field has explored novel fibrosis biomarkers, such as miRNA’s and circulating cell free DNAs (7,8). Liver stiffness measurement by transient elastography, acoustic radiation force impulse imaging, shear wave elastography, and MR elastography have been a major step forward in the assessment of hepatic fibrosis (2). However, these techniques are expensive and not widely available, particularly in developing countries. Current evidence noticeably indicates that liver fibrosis is a rather dynamic process ranging from stable, progressive, and regressive states (9). Currently, the causative agents of hepatic damage can be prevented by antivirals and further treatment for NASH and other diseases at the development stage. It is now not uncommon to observe regression of established cirrhosis. Thus, to predict and monitor clinically significant liver fibrosis with a reliable, reproducible, and non-invasive method is still an unmet clinical challenge, and new methods are awaited.

Serum biomarkers for the evaluation of liver fibrosis: The need for better tests