Performance characteristics of IMMULITE TPS: a comparison with TPS IRMA

Anticancer Res. 1999 Jul-Aug;19(4A):2743-7.

Abstract

This paper describes an automated immunoassay for the measurement of TPS developed for the IMMULITE. The IMMULITE system is a fully automated continous random access analyzer, which uses enzyme-amplified chemiluminiscent as the detection system. The IMMULITE TPS assay is a sequential, two-site chemiluminiscent enzyme immunometric assay designed for the quantitative measurement of TPS in serum. The IMMULITE TPS assay covers a clinical concentration range of 20-2400 U/L, with a lower detection limit of 6 U/L. A serum method comparison (n = 340) to the TPS IRMA assay demonstrates a correlation coefficient of 0.961 and a slope of 1.04. Samples run on IMMULITE TPS assay exhibit linearity upon dilution where recovered values fall within 15% of the theoretical sample value. The intra-assay precision of the IMMULITE TPS assay ranged from 3.3-4.7%, while the interassay precision ranged from 3.9-6.0%. By using different methods (immunoradiometric assay vs chemiluminiscent enzyme-labeled immunometric assay, one-step procedure vs sequential two-step procedure, manual vs fully automated procedure) the two TPS tumor marker tests used in this study gave quite comparable determinations for the sera from the cancer patients.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies, Monoclonal
  • Autoanalysis / instrumentation
  • Autoanalysis / methods
  • Biomarkers, Tumor / blood*
  • Breast Neoplasms / blood
  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / therapy
  • Calibration
  • Carcinoembryonic Antigen / blood
  • Colonic Neoplasms / blood
  • Colonic Neoplasms / diagnosis
  • Colonic Neoplasms / therapy
  • Female
  • Humans
  • Immunoassay / instrumentation*
  • Immunoassay / methods
  • Immunoradiometric Assay / instrumentation
  • Immunoradiometric Assay / methods
  • Luminescent Measurements
  • Peptides / blood*
  • Regression Analysis
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors

Substances

  • Antibodies, Monoclonal
  • Biomarkers, Tumor
  • Carcinoembryonic Antigen
  • Peptides
  • tissue polypeptide specific antigen