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)


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 


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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

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