Multi-platform, multi-site instrumentation and reagent standardization

Abstract

As flow cytometry laboratories involve themselves in more multi-site domestic and international clinical trial and research studies, it becomes imperative that they develop and adopt qualitative and quantitative standardization. This standardization does not need to be at the instrument- design level, but it may evolve from a general consensus on instrument setup, internationally accepted standardized procedures, and quantitative fluorescence intensity units. Instrument condition, age, and setup as well as model and manufacturer all affect the overall instrument performance and quantitative characteristics. Therefore, when working with multiple instruments, platforms, or sites, a standard window of analysis is essential. Furthermore, we should strive to characterize instrument performance and quantitative indices so that data can be compared directly. The same thoughts and ideals hold true for standardizing procedures and reagents. Clones, conjugation, incubation times, pH, temperature, and other environmental conditions all combine to affect the qualitative and quantitative cellular indices that we are attempting to measure. Data are presented that illustrates why standardization is needed and how we have attempted to achieve it in our laboratories.