Korean Journal of Hepatology (대한간학회지), Vol.7(4) : 467~474, 2001
Background / Aims : Prothrombin induced by Vitamin K Antagonist-Ⅱ(PIVKA-Ⅱ)and alpha-fetoprotein(AFP)subtype reacting with Lens Culinaris Agglutinin(AFP-L3)are known as specific tumor markers for HCC. Recently a more sensitive ELA method for PIVKA-Ⅱand an automatic analyzer with Liquid Phase Binding Assay method(LBA method)for AFP-L3 have been developed. The aim of this study was to evaluate the feasibility of PIVKA-Ⅱ and AFP-L3 measured by newly developed methods as complementary tumor markers to AFP in the diagnosis of HCC. Methods : The serum concentration of AFP, PIVKA-Ⅱ, and a fraction of AFP-L3 were determined from 188 patients with HCC and 118 patients with various liver diseases including tumors of the liver. AFP was measured by EIA, PIVKA-Ⅱ by sensitive EIA, and AFP-L3 by the LBA method with LiBASys Auto-analyzer. The cutoff values for AFP, PIVKA-Ⅱ, AND AFP-L3 WERE 400ng/mL, 40 Mau/mL, AND 15%, respectively. Results : The sensitivity and specificity of serum PIVKA-Ⅱwere 69.2% and 76.5%, respectively. Sixty-two(51.2%) of 121 patients with HCC, in which AFP was less than 400ng/mL were PIVKA-Ⅱ positive. The specificity and specificity of serum AFP-L3 were 48.8% and 90.8%, respectively. When AFP-L3 was used in combination with PIVKA-Ⅱ,31(46.3%) of the 67 patients with small less than 3cm HCC were positive for at least one of these markers. Conclusion : PIVKA-Ⅱ measures by sensitive EIA may be useful for the diagnosis of HCC with low AFP level. AFP-L3 and PIVKA-Ⅱ may improve the detection rate of small HCCs less than 3cm.