Development of a Chemiluminescence Immunoassay for Serum YB-1 and its Clinical Application as a Potential Diagnostic Marker for Hepatocellular Carcinoma

Background: y-box binding protein 1 (yb-1) overexpression has been shown in various tumor cells including hepatocellular carcinoma (hcc); moreover, this protein can be actively secreted. objectives: the aim of this study was to establish a method to quantify serum yb-1 and evaluate its clinical application in the clinical diagnosis of hcc. patients and methods: recombinant yb-1 and two populations of its antibodies were prepared. a monoclonal antibody was specific to the n-terminus of yb-1 amino acids 134-160; and another was a polyclonal antibody. a sandwich-type chemiluminescence immunoassay (clia) was developed and evaluated. levels of yb-1 and alpha fetoprotein (afp) in serum samples from 105 hcc patients, 25 hepatitis b virus patients, 25 cirrhosis patients, and 50 healthy donors were detected using the established method and an afp electrochemiluminescence kit. results: the developed method was linear to 150 μg/l of yb-1 with a minimum detection limit of 0.01 μg/l. the average recoveries were between 93.9% and 109.0%. the mean intra- and inter-assay coefficients of variation (cvs) were 4.0-4.8% and 8.2-10.2%, respectively. the relationship between the concentration of diluted yb-1 and the dilution ratios gave a good linear correlation coefficient of 0.9986. the yb-1 concentration was increased in serum of hcc patients (33.0 ± 23.39 μg/l) compared to healthy individuals (13.2 ± 5.29 μg/l, p < 0.0001), patients with hbv (17.9 ± 7.49 μg/l, p = 0.0003), and patients with hbv cirrhosis (20.7 ± 8.75 μg/l, p < 0.05). moreover, the combination of yb-1 and alpha-fetoprotein had a high sensitivity (89.5%) and reasonable specificity (62.0%) in identifying hcc. conclusions: the established method has an acceptable performance in quantifying yb-1. in addition, serum yb-1 may aid in the diagnosis of hcc.