The validation and meta-analysis of PIVKA-Ⅱ and AFP in the diagnosis of primary hepatocellular carcinoma

Objective: To compare the consistency of the results of prothrombin induced by vitamin K absence or antagonist-Ⅱ (PIVKA-Ⅱ) chemiluminescence and enzyme-linked immunosorbent assay, and to further verify the diagnostic performances of PIVKA-Ⅱ and AFP chemiluminescence on primary hepatocellular carcinoma. Methods: Spearman correlation coefficient analysis, Deviation analysis and the coincidence rate of negative or positive were used to evaluate the consistency of the results of chemiluminescence and enzyme-linked immunosorbent assay. We examined the levels of PIVKA-Ⅱ and AFP in healthy people, hepatitis and cirrhosis patients, as well as the hepatocellular carcinoma group. The critical value movement method was used to evaluate the specificity and sensitivity of PIVKA-Ⅱ and AFP in the diagnosis of hepatocellular carcinoma, and the results were compared with the diagnostic performance obtained through a meta-analysis. Results: The levels of PIVKA-Ⅱ of serum detected by the two methods were well correlated (R² = 0.925). PIVKA-Ⅱ was diagnosed with 40 mAU/mL as the cut-off value, and for patients with hepatocellular carcinoma, the coincidence rate of negative or positive was 100%. When PIVKA-Ⅱ < 200 mAU/mL, the absolute deviation detected by the two methods was less than 10 mAU/mL, and the relative deviation was mostly within 20%. PIVKA-Ⅱ and AFP had no correlation. When the critical values of PIVKA-Ⅱ and AFP were 26.5 mAU/mL and 15.5 ng/mL respectively, the sensitivity and specificity of PIVKA-Ⅱ and AFP in the diagnosis of hepatocellular carcinoma were 79.7% and 56.3%, respectively, and the specificity were 80.6% and 78.3%, respectively. The positive rate of the joint inspection of the two indicators could reach 86%. The results of this experiment were similar to those of the meta-analysis. Conclusion: The detection of PIVKA-Ⅱ by enzyme-linked immunoassay and electrochemiluminescence has a good comparability but there are still some differences. AFP combined with PIVKA-Ⅱ can improve the diagnosis efficiency of primary hepatocellular carcinoma. (authors)