Published online Oct 1, 1995. doi: 10.3748/wjg.v1.i1.33
Revised: September 18, 1995
Accepted: September 26, 1995
Published online: October 1, 1995
AIM: To determine the serum concentration of alpha-fetoprotein (AFP) with anti-human AFP variant monoclonal antibody (AFP-R-LCA mAb) in detection of hepatocellular carcinoma (HCC) and to ascertain the value of this tumor marker in the diagnosis of HCC.
METHODS: Cell fusion was used for the preparation of anti-human AFP-R-LCA mAb which was assayed with a two-site sandwich enzyme linked immunosorbent assay (ELISA) method. Using this method, the serum concentration of AFP-R-LCA was tested in 99 patients with HCC, 67 patients with benign liver diseases (BLD), 30 pregnant women, and 30 normal controls.
RESULTS: The threshold value of the serum AFP-R-LCA was set to 10 μg/L, in reference to normal controls. The concentration of AFP-R-LCA in serum was 1.27 ± 0.6 μg/L and 0 μg/L in pregnant women and controls, respectively. As shown by the rocket immune-electrophoresis, the serum AFP-R-LCA increased from 62.6% to 86.8% in HCC patients (P < 0.05) while the positive rates were decreased from 19.4% to 1.45% in BLD patients (P < 0.05) and from 26.7% to 0% in pregnant women (P < 0.05). The false positive rate was 1.5%; the two-site sandwich ELISA assay had a specificity of 99.0% in the diagnosis of HCC.
CONCLUSION: Our AFP-R-LCA variant mAb had a higher affinity and specificity to AFP-R-LCA than the routinely used anti-AFP polyclonal antibody. Anti-human AFP-R-LCA variant mAb two-site sandwich ELISA assay had a low false positive rate so that it could be used for both early diagnosis of HCC and the differential diagnosis of HCC and BLD. The method is simple, accurate, and reproducible.