Abstract
Objectives: To evaluate the diagnostic validity of PIVKA-II for Hepatocellular carcinoma in cirrhotic patients with uncertain liver nodules on Ultrasound.
 Methods: This was a cross-sectional study conducted in 01-11-2020 and 31-12-2021 at Hepatitis clinic at Jinnah Hospital Lahore. Patients who fulfilled the selection criteria(n=100) were enlisted for this study. Blood samples were obtained to test for PVKA-11 and AFP in cirrhotic patients who had liver nodules that had been previously verified by ultrasound imaging. Data were entered and analyzed in SPSS ver: 21.0. Sensitivity, specificity and predictive values were calculated using CT imaging and biopsy as gold standard. ROC curve evaluating AFP, PIVKA-II, and a combination as indicators for Hepatocellular carcinoma at 95% Confidence Interval was calculated with a p < .05 value was taken as statistical significant.
 Results: HCC was confirmed in 45 of the 100 instances, and it was invariably at an early or very early stage. At a threshold of 62.5 mAU/mL, PIVKA-II and HCC were significantly correlated (P =.015 and P =.036, respectively) in univariate and multivariate analyses. For AFP, 7.5 ng/mL was the ideal cut-off. For PIVKA- II, sensitivity was 62% and specificity was 91% , while for AFP, they are 66% and 69% respectively. The positive and negative predictive values for PIVKA-II were 81% and 74%, respectively, while for AFP sensitivity was 63% and specificity was 72%. The combination of both biomarkers improved the precision of diagnosing HCC (sensitivity = 74%, specificity = 95.5%, NPV = 81%, PPV = 92%, and AUC = 0.781).
 Conclusion: PIVKA-II is a valid indicator for defining the characteristics of liver nodules in cirrhosis and when combined with AFP, it signifies superior accuracy for HCC diagnosis.
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