Evaluation of two assays for the determination of serum AFP

Objective To investigate the clinical effectiveness of the time-resolved fluoroimmunoassay(TRFIA) and enzyme-linked immunosorbent assay(ELISA) methods in the determination of serum AFP levels for the patients of primary hepatic carcinoma(PHC).Methods Sixty-six patients with PHC and 60 healthy controls were included in this study.The serum levels of AFP were determined by TRFIA and ELISA,respectively.The correlation,linearity,precision,sensitivity and specificity of two assays were evaluated.Results The serum levels of AFP for TRFIA and ELISA in 66 patients with PHC were(185.36±118.22)ng/L and(216.25±193.20)ng/ml,respectively.The diagnostic specificity and sensitivity were 98.33% and 78.78% for TRFIA,and 96.66% and 68.18% for ELISA,respectively.However,in 60 healthy controls,these were(5.31±3.57)ng/L and(14.75±6.80)ng/ml,respectively.The diagnostic specificities were 98.33% and 96.66% for TRFIA and ELISA,respectively.TRFIA had higher sensitivity than ELISA(P0.05),but the specificities of both assays were similar(P0.05).There was excellent correlation between TRFIA and ELISA.The linear ranges of AFP were 0.73~1 066.00 ng/L,and 4.22~534.00 ng/L for TRFIA and ELISA,respectively.TRFIA was superior to ELISA for the determination range,within-batch and between-batch precision.Conclusion The results indicate that both TRFIA and ELISA meet the clinical diagnostic needs,but the sensitivity,linearity and precision of TRFIA are superior to ELISA for identifying the patients with PHC.