Reliable immune profiling across global studies depends on methods that perform consistently, regardless of where they are run. We address this question in the white paper entitled “Cross-Site Validation of a 15-Color Spectral Cytometry Panel for Leukocyte Profiling,” documenting a global collaboration between KCAS Bio and its strategic partner, Crux Biolabs, to harmonize and validate a standardized 15-color spectral flow cytometry panel for pan-leukocyte profiling across multiple sites. The goal was to ensure consistent immune cell identification regardless of laboratory location or instrumentation.
Rigorous multi-level validation strategy
The study evaluated key performance parameters, including intra-assay precision, inter-analyst reproducibility, inter-instrument comparability, and cross-site consistency. These validation steps are essential for assays intended for multi-center research and clinical studies, where data must be comparable across sites.
Strong performance across non-rare and rare populations
The panel demonstrated excellent precision across all sites. Coefficients of variation remained below 25% for non-rare leukocyte populations and below 35% for rare subsets, meeting established acceptance criteria in the field and confirming reliable measurement of both abundant and low-frequency immune cells.
Consistency across global study sites
Cross-site validation showed that the assay produced uniform results when the same samples were analyzed at different locations. This confirms the robustness of the method and its ability to overcome common challenges in global, multi-center clinical programs.
A scalable model for complex clinical programs
This work reflects KCAS Bio’s standard approach to global harmonization, whether deploying a validated off-the-shelf assay or developing a custom flow cytometry solution. The validated 15-color spectral panel provides a reliable foundation for consistent immune profiling in research and clinical applications worldwide.
Discover the full white paper to learn how cross-site validation strengthens data confidence and enables reliable immune profiling at a global scale.