Elecsys® PIVKA-II is an immunoassay for the quantitative measurement of protein induced by vitamin K absence or antagonist-II (PIVKA‑II) in human serum and plasma. The assay is used as an aid in the diagnosis of hepatocellular carcinoma (HCC). The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.
Hepatocellular carcinoma (HCC)
Hepatocellular carcinoma (HCC) constitutes a major global health problem. HCC is the 6th most common cancer worldwide and the most common primary liver malignancy and is a leading cause of cancer-related death worldwide: it accounts for more than 90 % of primary liver cancer.1,2,3 It is the 2nd most common cause of death from cancer in males and the 6th in females worldwide. Major risk factors of developing HCC are infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as indicated by the strong correlation between the prevalence of HCC and chronic hepatitis B and C.4 HCC is an aggressive cancer that occurs in the setting of cirrhosis and commonly presents in advanced stages.5 Early diagnosis and intervention can thus significantly improve survival.6
Protein induced by vitamin K or antagonist-II (PIVKA-II; also known as des-γ-carboxy prothrombin [DCP]) has been identified as a promising biomarker with utility in the surveillance, diagnosis, and management of HCC.7 PIVKA‑II is a precursor and abnormal form of prothrombin which was found originally in patients with HCC.8 In the absence of vitamin K or the presence of its antagonist inhibiting vitamin K-dependent carboxylase activity, PIVKA-II is generated with a loss of coagulation activity.9 In neoplastic cells of HCC, PIVKA-II is thought to be produced as consequence of an acquired defect of post-translational carboxylation of prothrombin’s precursor.