Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein

D. W. Chan, M. Kelsten, R. Rock, D. Bruzek

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17 Scopus citations


A monoclonal immunoenzymometric assay for alpha-fetoprotein was evaluated for detection and monitoring of hepatocellular carcinoma (HCC). We studied 1343 serum specimens from 759 patients with various neoplastic and non-neoplastic diseases. The interassay CV for this assay (M-AFP) ranged from 3.5 to 5.5%, with a minimum detectable concentration of 2.2 μg/L, as compared with 10 μg/L for a polyclonal (P-AFP) RIA for AFP. The calibration curve (0-300 μg/L) was linear, and serum dilutions paralleled it. The reference interval (0-9 μg/L) was established from data on 111 health subjects. Regression analysis of the AFP concentration (0-300 μg/L) of HCC patients obtained with the M-AFP assay (y) and the P-AFP RIA (x) yielded the equation y = (1.125)x - 0.52 (r = 0.9395, n = 165), with a considerable number of discrepant results for AFP < 100 μg/L. By M-AFP immunoassay, AFP was above-normal (> 9 μg/L) in most HCC patients (80%), and to a lesser extent in other liver tumors (48%). AFP was within the normal reference interval for most patients with germ-cell tumors or benign liver disease and for other disease groups. For maximum diagnostic efficiency (90%) for HCC the decision level was increased to 100 μg of AFP per liter. Changes in serum AFP were correlated with changes in tumor volume in most HCC patients.

Original languageEnglish (US)
Pages (from-to)1318-1322
Number of pages5
JournalClinical chemistry
Issue number7
StatePublished - 1986

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical


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