Performance of Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) for Hepatocellular Carcinoma Screening in Chinese Population

BACKGROUND: Alpha-fetoprotein (AFP) has long been used as an effective biomarker for hepatocellular carcinoma (HCC) screening; however, not all HCC patients can be detected with an elevated AFP level, especially in early HCC patients. Protein Induced by vitamin K absence or antagonist-II (PIVKA-II) is another serum biomarker linked to HCC; however, sensitivity and specificity remain controversial and data in Chinese groups is even rarer. OBJECTIVES: To evaluate the performance of PIVKA-II alone and combined with AFP in HCC screening in Chinese population. PATIENTS AND METHODS: This retrospective study enrolled 150 HCC patients in Southwest Hospital, of which 16 patients were excluded due to lack of basic information. A total of 347 patients with hepatitis B, 105 with non-HCC cancers and 53 healthy people were enrolled as controls. Levels of AFP and PIVKA-II were measured by chemiluminescence enzyme immunoassay (CLEIA) and chemiluminescent microparticle Immunoassay (CMIA), respectively. RESULTS: The sensitivity and specificity of PIVKA-II were 74.6% and 67.8% at a cutoff of 40 mAU/mL and 64.2% and 89.7% at a cutoff of 200 mAU/mL. The sensitivity and specificity of AFP were 76.7% and 65.0% at a cutoff of 20 ng/mL and 60.4% and 88.9% at a cutoff of 195.23 ng/mL. The combination of two markers had a sensitivity and specificity of 91.1% and 41.0%, respectively. The area under the receiving operating curve (AUROC) for PIVKA-II (0.756, 95% confidence interval, CI: 0.695 - 0.816) was less than the AUROC for AFP (0.823, 95% CI: 0.780 - 0.865), and in combination, the AUROC increased to 0.843 (95% CI: 0.801 - 0.885). CONCLUSIONS: PIVKA-II was as efficient as AFP when used as a single marker for HCC screening and the combination of two biomarkers gave a better performance.