Diagnostic Test of PIVKA-II as A Tumor Marker for Hepatocellular Carcinoma

Abstract

Alpha-Fetoprotein (AFP) is a tumor marker that has been widely used for HCC, but there has been no increased AFP in 35-45% patients with HCC. Protein induced by vitamin K absence or antagonist II (PIVKA-II) is abnormal prothrombin secreted in HCC and is expected to be used as a diagnostic marker of HCC. The objective of this study was to compare serum PIVKA-II levels in the patients with HCC, cirrhosis, and healthy control and determine the diagnostic value of PIVKA-II for hepatocellular carcinoma. This was a cross-sectional, analytical observational study to identify the diagnostic value of
PIVKA-II for HCC diagnosis. The diagnosis of 20 cirrhotic patients and 15 patients with HCC was established by using medical history, physical examination, and additional tests according to the diagnosis criteria. A group of 12 individuals with normal liver function was used as healthy control subjects. Serum PIVKA-II levels were analyzed with the immunoassay method. For the comparison study, the independent-samples Kruskal Wallis test was used. Also, to determine sensitivity, specificity,
positive and negative predictive value (PPV and NPV), ROC curve analysis, and 2x2 contingency table was used. The serum PIVKA-II levels in the patients with HCC were significantly higher than in cirrhotic patients (p=0.000) and healthy control (p=0.000). Sensitivity, specificity, PPV, and NPV of PIVKA-II for diagnosis of HCC in cirrhotic patients at a cut-off value of 140.85 mAU/mL were 93.33%, 75%, 73.68%, and 93.75%, respectively (AUC=0.87).PIVKA-II had a high diagnostic value for HCC diagnosis. Diagnostic tests that compare serum PIVKA-II levels in any size of HCC nodules might be needed in the
future.