Background. Serum alpha-fetoprotein (AFP) is elevated in up to 80% of
patients with hepatocellular carcinoma (HCC). Modestly raised AFP leve
ls (10-400 ng/ml) are also found in patients with nonmalignant liver d
iseases. In the present study, isoelectric focusing of AFP was used to
differentiate the AFP found in patients with HCC. Methods. To establi
sh the assay conditions, isoelectric focusing was performed on sera fr
om 14 patients with HCC and 13 with nonmalignant liver diseases. Sera
was also analyzed under coded conditions from 16 patients with HCC, 14
with chronic active hepatitis (CAH), and 6 with cirrhosis to determin
e the specificity and sensitivity of the assay in the diagnosis of HCC
. Results. Isoelectric focusing of sera from patients with HCC and var
ious non malignant liver diseases identified AFP variants (AFP I-IV).
All 14 patients with HCC had AFP variants I and III, and 7 of the 14 a
lso had variant IV, When analyzed in the coded study 13 of the 16 case
s of HCC were predicted correctly by the presence of AFP variants III
or III and IV. AFP bands III and IV were not discernible in 12 of the
14 patients with CAH and 4 of the 6 with cirrhosis. Conclusion. Isoele
ctric focusing of sera from patients with HCC and nonmalignant liver d
isease identified two AFP variants apparently specific for HCC. In the
setting of borderline elevation of AFP, this technique has a sensitiv
ity of 81% and specificity of 85% for detecting the presence of bands
III or IV and may prove suitable for use in a routine laboratory as a
screening assay.