Diagnostic accuracy of PIVKA-II, alpha-fetoprotein and a combination of both in diagnosis of hepatocellular carcinoma in patients affected by chronic HCV infection

are at high risk for developing hepatocellular carcinoma (HCC). The aim of this study was to evaluate the feasibility of PIVKA-II (protein induced by Vitamin K absence or antagonist-II) alone or in combination with α-1 fetoprotein (AFP), as a screening marker for development of HCC. Materials and Methods: A case-control study was conducted in 2 hospital wards in Naples. All anti-HCV-positive patients affected by HCC were considered as cases, while consecutive anti-HCV-positive patients without HCC were considered as controls. Results: Overall, 160 patients were enrolled, 56 cases and 104 controls. At the set cut-off of 36 mAU/ml, PIVKA-II was more sensitive (78.6% vs. 60%), but less specific than AFP at the set cut-off of 12 ng/ml (66.3% vs. 77.2%). The negative predictive value of PIVKA in combination with AFP was 93.2%. Conclusion: PIVKA II, when combined with AFP, may be considered as a screening test for HCC due to its high negative predictive value.