Reproducibility studies for experimental epitope detection in macrophages (EDIM)

D. Japink, M. Nap, M.N. Sosef, P.J. Nelemans, J.F. Coy, G. Beets, M.F. von Meyenfeldt, M P G. Leers

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Abstract

INTRODUCTION: We have recently described epitope detection in macrophages (EDIM) by flow cytometry. This is a promising tool for the diagnosis and follow-up of malignancies. However, biological and technical validation is warranted before clinical applicability can be explored. METHODS: The pre-analytic and analytic phases were investigated. Five different aspects were assessed: blood sample stability, intra-individual variability in healthy persons, intra-assay variation, inter-assay variation and assay transferability. The post-analytic phase was already partly standardized and described in an earlier study. RESULTS: The outcomes in the pre-analytic phase showed that samples are stable for 24h after venipuncture. Biological variation over time was similar to that of serum tumor marker assays; each patient has a baseline value. Intra-assay variation showed good reproducibility, while inter-assay variation showed reproducibility similar to that of to established serum tumor marker assays. Furthermore, the assay showed excellent transferability between analyzers. CONCLUSION: Under optimal analytic conditions the EDIM method is technically stable, reproducible and transferable. Biological variation over time needs further assessment in future work.
Original languageEnglish
Pages (from-to)40-47
Number of pages8
JournalJournal of Immunological Methods
Volume407
DOIs
Publication statusPublished - May 2014

Keywords

  • Flowcytometry
  • Reproducibility
  • Epitope detection in macrophages
  • Colorectal Cancer
  • Pre-analytic
  • Analytic
  • BIOLOGICAL VARIATION
  • TUMOR-MARKERS
  • ANALYTICAL IMPRECISION
  • PRACTICE GUIDELINES
  • COLORECTAL-CANCER
  • PROSTATE-CANCER
  • BLOOD-TEST
  • CEA
  • CYTOKERATIN

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