[Clinical Significance of Novel Serum Biomarkers in the Management of Liver Diseases].

Serum biomarkers are playing an increasingly important role in the management of liver diseases. In this article, we provide an overview of the biomarkers that are currently used for the primary diagnosis of liver fibrosis, hepatocellular carcinoma (HCC), and occult hepatitis B virus (HBV) infection. Because liver fibrosis is a significant risk factor for hepatocarcinogenesis, monitoring its progression is important for predicting and preventing HCC. In 2015, the novel liver fibrosis glycobiomarker Wisteriaflori- bunda agglutinin-positive Mac-2 binding protein (WFA'-M2BP, M2BP glycan isomer [M2BPGiI) became available in Japan. The HISCL M2BPGi assay is fully automated, rapid (17 minutes), and requires only a small sample volume (10 μL). Serum tumor markers are noninvasive and valuable for the management of patients with a high risk of de- veloping HCC. Although a-fetoprotein (AFP) has been commonly used, its insufficient sensitivity and specificity for early-stage HCC make it unsuitable for managing patients at high risk of developing HCC. However, a combination of AFP and protein induced by vitamin K absence factor II (PIVKA-II), or Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3) and PIVKA-II are currently being evaluated for HCC pre- diction. Recently, a highly sensitive chemiluminescent enzyme immunoassay (CLEIA) for HBsAg detection by Lumipulse HBsAg-HQ has been reported as the latest clinical application. Although the sensitivity of this assay ( ≥5 mIU/mL) is 10-fold higher than that of the conventional assay, it is still lower than that of the HBV-DNA assay. HBsAg-HQ will be applied for detecting occult HBV infection and HBV reactivation. [Review].