Reproducibility studies for experimental epitope detection in macrophages (EDIM)

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. The pre-analytic and analytic phase...

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Bibliographic Details
Published in:Journal of immunological methods 2014-05, Vol.407, p.40-47
Main Authors: Japink, Dennis, Nap, Marius, Sosef, Meindert N., Nelemans, Patty J., Coy, Johannes F., Beets, Geerard, von Meyenfeldt, Maarten F., Leers, Math P.G.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Analytic
Biomarkers, Tumor - analysis
Cell Separation
Colorectal Cancer
Colorectal Neoplasms - diagnosis
Colorectal Neoplasms - immunology
Epinephrine - analysis
Epitope detection in macrophages
Female
Flow Cytometry
Flowcytometry
Humans
Macrophages - immunology
Male
Middle Aged
Pre-analytic
Reproducibility
Reproducibility of Results
Sensitivity and Specificity
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Summary: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. 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. 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. Under optimal analytic conditions the EDIM method is technically stable, reproducible and transferable. Biological variation over time needs further assessment in future work. •Common CRC blood diagnostics and monitoring lack sensitivity and specificity.•The EDIM assay is a promising novel epitope detection method in macrophages for CRC.•Intra- and inter-assay and transferability assessment showed reproducible results.•Biological variability is interfering as usual with assay reproducibility.•EDIM-assay performs technically similar to serum tumor marker assays.
ISSN:0022-1759
1872-7905
DOI:10.1016/j.jim.2014.03.018