Abstract
In this report, we discuss our analytical and clinical evaluations of assays of HCC tumor markers, namely, AFP, AFP-L3, and PIVKA II, using a fully automated microfluidic immunoassay system with the laser-induced fluorescence (LIF) detector, the μ TAS Wako i30 (Wako Pure Chemical Industries, Ltd., Osaka, Japan). The robust performance of these assays on μ TAS Wako i30 satisfied the requirements for daily clinical use, and the combination of AFP-L3%, PIVKA II, and total AFP measurements resulted in higher true positive and true negative rates for HCC diagnostics than AFP measurement alone. These observations suggest that the μ TAS Wako i30 AFP-L3% and PIVKA II assay combination is a useful tool for aiding in the diagnosis of HCC.