BACKGROUND: We assessed clinical and analytical performances of AFP and fucosylated AFP (AFP-L3) assays by a newly developed automated analyzer based on liquid-phase binding (micro-total analysis systems, μTAS). METHODS: A total of 239 serum samples were obtained from 120 patients with hepatocellular carcinoma (HCC) and 119 without HCC. Precision of assays by the μTAS was evaluated, and the correlation between AFP-L3 and AFP levels was analyzed. Receiver operating characteristics curve-area under the curve (ROC-AUC) value was calculated to measure the diagnostic performance. RESULTS: Imprecision for AFP (ng/ml), AFP-L3 (ng/ml), and AFP-L3 (%) with 2 levels of QC materials was all within 5% coefficient of variation. AFP levels measured by the μTAS were correlated well with those by the UniCel DxI 800 Access (r=0.83). AFP-L3 concentrations in HCC patients were higher than those in control group (median 379.2 ng/ml in HCC, 1.0 ng/ml in non-HCC, P<0.05). AUC of AFP-L3 was 0.91 which was significantly higher than that of AFP (0.88 by μTAS; 0.84 by UniCel DxI 800, P<0.05 for both). CONCLUSION: AFP-L3 in HCC was significantly higher than that of control group. The μTAS showed good performances for routine uses in clinical laboratories for measuring AFP and AFP-L3.
BACKGROUND: We assessed clinical and analytical performances of AFP and fucosylated AFP (AFP-L3) assays by a newly developed automated analyzer based on liquid-phase binding (micro-total analysis systems, μTAS). METHODS: A total of 239 serum samples were obtained from 120 patients with hepatocellular carcinoma (HCC) and 119 without HCC. Precision of assays by the μTAS was evaluated, and the correlation between AFP-L3 and AFP levels was analyzed. Receiver operating characteristics curve-area under the curve (ROC-AUC) value was calculated to measure the diagnostic performance. RESULTS: Imprecision for AFP (ng/ml), AFP-L3 (ng/ml), and AFP-L3 (%) with 2 levels of QC materials was all within 5% coefficient of variation. AFP levels measured by the μTAS were correlated well with those by the UniCel DxI 800 Access (r=0.83). AFP-L3 concentrations in HCC patients were higher than those in control group (median 379.2 ng/ml in HCC, 1.0 ng/ml in non-HCC, P<0.05). AUC of AFP-L3 was 0.91 which was significantly higher than that of AFP (0.88 by μTAS; 0.84 by UniCel DxI 800, P<0.05 for both). CONCLUSION:AFP-L3 in HCC was significantly higher than that of control group. The μTAS showed good performances for routine uses in clinical laboratories for measuring AFP and AFP-L3.