Advertisement

Analytical Aspects of Biomarker Immunoassays in Cancer Research

  • Fred C. G. J. Sweep
  • Chris M. G. Thomas
  • Manfred Schmitt
Part of the Cancer Drug Discovery and Development book series (CDD&D)

Abstract

Many difficulties associated with immuno(metric) assay kits designed for quantification of a particular biomarker arise from their variation in specificity and binding affinity of the employed antibodies. Other important sources causing varying assay results are the use of different standard preparations in these kits and the nonuniform preanalytical specimen processing procedures employed, each of which should be subjected to standardization. To improve the performance and comparability of assays, continuous interlaboratory external quality control procedures are needed. Such quality assurance programs provide a forum for expert laboratory investigators to discuss technical details and to exchange laboratory issues and related practical information. This chapter addresses some of these issues and presents initial analytical validation procedures of newly developed biomarker assays, the validation of already established assay procedures for routine use on a day-to-day basis, and finally discusses some aspects on adequate (external) quality control proficiency testing.

Key Words

Biomarkers immunoassay cancer tumor markers 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Hayes DF, Bast RC, Desc CE, et al. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 1996;88:1456–1466.PubMedCrossRefGoogle Scholar
  2. 2.
    McGuire WL, Clark GM. Prognostic factors and treatment decisions in axillary-node-negative breast cancer. N Engl J Med 1992;326:1756–1761PubMedCrossRefGoogle Scholar
  3. 3.
    Benraad ThJ, Geurts-Moespot J, Grondahl-Hansen J, et al. Immunoassays (ELISA) of urokinase-type plasminogen activator (uPA): report of an EORTC/BIOMED-1 workshop. Eur J Cancer 1996;32A:1371–1381.PubMedCrossRefGoogle Scholar
  4. 4.
    Dittadi R, Meo S, Fabris F, et al. Validation of blood collection procedures for the determination of circulating vascular endothelial growth factor (VEGF) in different blood compartments. Int J Biol Markers 2001;16:87–96.PubMedGoogle Scholar
  5. 5.
    Biganzoli E, Boracchi P, Daidone MG, Gion M, Marubini E. Flexible modelling in survival analysis. Structuring biological complexity from the information provided by tumor markers. Int J Biol Markers 1998;13:107–123.PubMedGoogle Scholar
  6. 6.
    McGuire WL. Breast cancer prognostic factors: evaluation guidelines. J Natl Cancer Inst 1991;83:154–155.PubMedCrossRefGoogle Scholar
  7. 7.
    Stamey TA, Chen Z, Prestigiacomo AF. Reference material for PSA: the IFCC standardization study. International Federation of Clinical Chemistry. Clin Biochem 1998;31:475–481.PubMedCrossRefGoogle Scholar
  8. 8.
    Kricka LJ. Human anti-animal antibody interferences in immunological assays. Clin Chem 1999;45:942–956.PubMedGoogle Scholar
  9. 9.
    Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewart chart for quality control in clinical chemistry. Clin Chem 1981;27:493–501.PubMedGoogle Scholar
  10. 10.
    Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol 1950;20:1059–1066.PubMedGoogle Scholar
  11. 11.
    Geurts-Moespot J, Leake R, Benraad ThJ, Sweep CGJ. Twenty years of experience with the steroid receptor External Quality Assessment program—the paradigm for tumour biomarker EQA studies (review). Int J Oncol 2000;17:13–22.PubMedGoogle Scholar
  12. 12.
    Jänicke F, Prechtl A, Thomssen C, et al. Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1. J Natl Cancer Inst 2001;93:913–920.PubMedCrossRefGoogle Scholar
  13. 13.
    Look MP, van Putten WLJ, Duffy MJ, et al. Pooled analysis of prognostic impact of urokinase-type plasminogen activator and its inhibitor PAI-1 in 8377 breast cancer patients. J Natl Cancer Inst 2002;94:116–128.PubMedGoogle Scholar
  14. 14.
    Sweep CGJ, Geurts-Moespot J, Grebenschikov N, et al. External quality assessment of trans-European multicentre antigen determinations (ELISA) of urokinase-type plasminogen activator (uPA) and its type-1 inhibitor (PAI-1) in human breast cancer tissue extracts. Br J Cancer 1998;78:1434–1441.PubMedGoogle Scholar

Copyright information

© Humana Press Inc., Totowa, NJ 2006

Authors and Affiliations

  • Fred C. G. J. Sweep
    • 1
  • Chris M. G. Thomas
    • 1
  • Manfred Schmitt
    • 2
  1. 1.Department of Chemical EndocrinologyUniversity Medical Centre NijmegenNijmegenThe Netherlands
  2. 2.Clinical Research Unit, Department of GynecologyTechnical University of MunichMunichGermany

Personalised recommendations