Background/aims: The usefulness of abnormal prothrombin (PIVKA-II) for diagnosis of small HCC has been limited by its low sensitivity, despite a high specificity.
Methodology: The serum concentration of PIVKA-II was determined by using a new sensitive enzyme immunoassay (EIA) kit in patients with hepatocellular carcinoma (HCC), liver cirrhosis (LC), or chronic hepatitis (CH) and normal controls (NC). alpha-Fetoprotein (AFP) was simultaneously determined in same patients.
Results: This kit has made it possible to detect low concentrations of PIVKA-II in the NC. The serum PIVKA-II concentration (mean +/- SE) was 15.7 +/- 1.1 mAu/ml, 16.1 +/- 2.0 mAu/ml, 26.3 +/- 7.2 mAu/ml and 5420.3 +/- 3960.0 mAu/ml in NC, CH, LC and HCC, respectively. Among 106 patients with HCC, 74 patients (69.8%) were positive for PIVKA-II (> or = 40 mAu/ml), while only 9 patients out of 68 patients with LC were positive (13.2%) and only 2 out of 90 patients with CH were positive (2.2%). No significant correlation was observed between AFP and PIVKA-II levels. With combined assay of AFP and PIVKA-II, the positive rate for HCC was increased to 78.3%. Among 14 patients with HCC < 20 mm in diameter. 7 were positive for PIVKA-II, and 6 out of 10 patients with HCC between 20 and 30 mm in diameter were positive for PIVKA-II. There was a correlation between tumor size and the PIVKA-II level.
Conclusions: Determination of PIVKA-II by this new EIA kit could be useful for the diagnosis of HCC, especially combined with determination of AFP.