Trastuzumab quantification in serum: A new, rapid, robust ELISA assay based on a mimetic peptide that specifically recognizes trastuzumab

Barbara Cardinali, Gianluigi Lunardi, Enrico Millo, Andrea Armirotti, Gianluca Damonte, Aldo Profumo, Stefania Gori, Giuseppina Iacono, Alessia Levaggi, Lucia Del Mastro

Research output: Contribution to journalArticle

Abstract

Trastuzumab, a humanized monoclonal antibody directed against the epidermal growth factor receptor 2 (HER2), is a milestone in the treatment of HER2-overexpressing breast cancer patients. An enzyme-linked immunosorbent assay (ELISA) for trastuzumab has been developed for routine use in the laboratory to support clinical and pharmacokinetic studies to optimize therapy. The method relies on an antigen peptide linked to a 96-well plate via the streptavidin/biotin system. The peptide sequence mimics the extracellular portion of the HER2 receptor that is recognized by trastuzumab. The calibration range of the assay is 10 to 360 ng/mL per well, corresponding to a trastuzumab serum concentration from 5 to 180 μg/mL with a lower limit of quantification of 10 μg/mL. Validation results demonstrate that trastuzumab can be accurately and precisely quantified in human serum using this assay. The procedure was also tested in sera obtained from breast cancer patients to evaluate trastuzumab serum levels, confirming the applicability of method that could be a valid assay to use in daily laboratory practice.

Original languageEnglish
Pages (from-to)4557-4561
Number of pages5
JournalAnalytical and Bioanalytical Chemistry
Volume406
Issue number18
DOIs
Publication statusPublished - 2014

Keywords

  • Breast cancer
  • ELISA
  • HER2/neu receptor
  • Pharmacokinetics
  • Trastuzumab

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Medicine(all)

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