Qualified Flow Cytometry Immunophenotyping Assays for Use in Clinical Trials
Panels for T-cell, B-cell and NK cell (TBNK) for the detection of T cells including the CD4 and CD8 subsets, B cells, NK cells, NKT cells lymphocytes and monocytes, and T-helper (Th) which identifies several key functional T lymphocyte subsets (Th1, Th2, Th17) have been developed and partially validated. These assays show suitable precision between donors and runs, including for lower frequency cell populations such as Th17 cells
Markers detected by the TBNK and Th panels
| BV421 | BV510 | Ax488 | PE | PerCP Cy5.5 |
PECy7 | Ax647 | APC-Cy7 | |
| TBNK | CD3 | Fix L/D Aqua | CD45 | CD14 | CD4 | CD19 | CD16 / CD56 |
CD8 |
| Th | CD3 | Fix L/D Aqua | - | CD183 | CD4 | CD196 | CD161 | CD8 |
Assay Characteristics
Validated with both whole blood and cryopreserved PBMCs
Qualified for use with several commonly used anti-coagulants
Reproducibility with low event #
1000 events for the TBNK panel
5000 lymphocyte events for the Th panel
Good inter- and intra-assay precision
Cross-site validated at both Eurofins Bioanalytical Services facilities
