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

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. To evaluate the performance of PIVKA-II alone and combined with AFP in HCC screening in Chinese population. 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. 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). 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.