Elecsys^® PIVKA-II

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.^1,2

Hepatocellular carcinoma (HCC)^1,2

Hepatocellular carcinoma (HCC) constitutes a major global health problem. HCC is the 5^th most common cancer worldwide and the most common primary liver malignancy and is the 3^rd leading cause of cancer-related death worldwide: it accounts for more than 90 % of primary liver cancer.^3,4,5 It is the 2^nd most common cause of death from cancer in males and the 6^th 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.⁶ Survival is poor in most patients with HCC (5-year survival less than 5%) except in patients in the early stage who receive potentially curative therapy (liver transplant, surgical resection, or ablation), where a considerable improvement in survival has been observed (5-year survival ranges between 40% and 70%).⁷

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.^8,9 PIVKA‑II is a precursor and abnormal form of prothrombin which was found originally in patients with hepatitis and cirrhosis.⁹ 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.^10,11In 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.¹²