Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein

Daniel Wan-Yui Chan, M. Kelsten, R. Rock, D. Bruzek

Research output: Contribution to journalArticle

Abstract

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
Volume32
Issue number7
StatePublished - 1986

Fingerprint

alpha-Fetoproteins
Tumors
Hepatocellular Carcinoma
Assays
Liver
Regression analysis
Dilution
Serum
Health
Calibration
Germ Cell and Embryonal Neoplasms
Tumor Burden
Monitoring
Liver Diseases
Regression Analysis
Neoplasms

ASJC Scopus subject areas

  • Clinical Biochemistry

Cite this

Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein. / Chan, Daniel Wan-Yui; Kelsten, M.; Rock, R.; Bruzek, D.

In: Clinical Chemistry, Vol. 32, No. 7, 1986, p. 1318-1322.

Research output: Contribution to journalArticle

Chan, DW-Y, Kelsten, M, Rock, R & Bruzek, D 1986, 'Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein', Clinical Chemistry, vol. 32, no. 7, pp. 1318-1322.
Chan, Daniel Wan-Yui ; Kelsten, M. ; Rock, R. ; Bruzek, D. / Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein. In: Clinical Chemistry. 1986 ; Vol. 32, No. 7. pp. 1318-1322.
@article{d1844936a79049fab9c0ca5132240bc6,
title = "Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein",
abstract = "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.",
author = "Chan, {Daniel Wan-Yui} and M. Kelsten and R. Rock and D. Bruzek",
year = "1986",
language = "English (US)",
volume = "32",
pages = "1318--1322",
journal = "Clinical Chemistry",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "7",

}

TY - JOUR

T1 - Evaluation of a monoclonal immunoenzymometric assay for alpha-fetoprotein

AU - Chan, Daniel Wan-Yui

AU - Kelsten, M.

AU - Rock, R.

AU - Bruzek, D.

PY - 1986

Y1 - 1986

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0022894647&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0022894647&partnerID=8YFLogxK

M3 - Article

C2 - 2424638

AN - SCOPUS:0022894647

VL - 32

SP - 1318

EP - 1322

JO - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

IS - 7

ER -