Abstract
<p><strong>Background and Objective:</strong> Chitinase-3-like protein 1 (CHI3L1) is an upcoming biomarker for the diagnosis of liver fibrosis. The reference intervals (RIs) for CHI3L1 have not been established in the Pakistani population. Thus, this study aimed to determine the RIs in our population and the cut-off value for diagnosis of hepatic fibrosis.</p>
 <p><strong>Methods:</strong> This is a cross-sectional study. A total of 408 participants (202 healthy and 206 diagnosed liver fibrosis cases) were recruited. Serum CHI3L1 level was measured on CHI3L1 kits (Proprium Biotech Co. Ltd) by manual enzyme-linked immunosorbent assay. The RIs were estimated by percentile and working normal method.</p>
 <p><strong>Results:</strong> The distribution of CHI3L1 values showed no remarkable variation with gender and age. The 95% RI of CHI3L1 was 12.80-81.80 ng/ ml in healthy Pakistani subjects and the cut-off for the diagnosis was 102.12 ng/ml in hepatic fibrosis cases.</p>
 <p><strong>Conclusion:</strong> The RIs in healthy adults and the cut-off for the diagnosis of hepatic fibrosis of serum CHI3L1 were determined in a selective adult Pakistani population. This will be a useful reference for further local and international studies.</p>
Highlights
Hepatic fibrosis is a healing response of hepatocytes to chronic and repeated damage caused by multiple agents like viruses, toxins, alcohol abuse, and other causes
Our reference intervals (RIs) in healthy and diseased patients were calculated by the percentile method and working normal method, respectively
We determined the RIs by using the interval covering the 2.5 to 97.5 percentile of cases in healthy individuals and the lower 5th percentile cut-off for the diagnosis of hepatic fibrosis via the traditional normal theory formula in hepatic fibrosis cases
Summary
Hepatic fibrosis is a healing response of hepatocytes to chronic and repeated damage caused by multiple agents like viruses, toxins, alcohol abuse, and other causes. Chitinase-3-like protein 1 (CHI3L1), known as YKL-40 and cartilage glycoprotein 39, is cited as a novel biomarker for the diagnosis of hepatic fibrosis. Prior studies have implicated CHI3LI involvement in hepatic fibrosis, in areas of active scar tissue formation due to various causes.[2,3] It is a glycoprotein composed of 383 amino acids and weighs 42.6 kd. In other species, it hydrolyzes the β-(1, 4)-linkage between the adjacent N-acetyl glucosamine residues of chitin; in humans, it has high affinity for chitin but no chitinase activity because of a mutation in its active site.[4]. This study aimed to determine the RIs in our population and the cut-off value for diagnosis of hepatic fibrosis
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