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 language | English |
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Pages (from-to) | 40-47 |
Number of pages | 8 |
Journal | Journal of Immunological Methods |
Volume | 407 |
DOIs | |
Publication status | Published - 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