Universal leukoreduction of cellular and plasma components: process control and performance of the leukoreduction process.

Many countries in Europe and over the world are currently or will be concerned in the near future, by the implementation of universal leukoreduction (ULR) for red blood cells (RBC), platelets (PT) and now also for plasma. Recommended by several advisory committees, this decision to implement ULR must be considered as a recognition of the benefit of early leukocyte removal, and also as a precautionary measure to increase blood safety. The leukodepletion technology for RBC, PT and plasma has become increasingly more elaborated and integrated in the collection or in the component preparation process. To reach this aim and to assure that the end-products meet local specifications (1 or 5 x 10(6) residual leukocytes), a process control and validation program for leukoreduction has been described in the specific guidelines. Tested on a wide scale by a group of centers, flow cytometry is emerging as reference method for residual leukocyte enumeration. Validation protocols (linearity, precision, accuracy) have been defined in numerous national or international studies (PSL and BEST Working Party). The sensitivity of the method is greatly improved by concentration of the sample, with a detection limit equivalent to 10 cells/mL for RBC or PT, and 0.5 cells/mL for plasma. Furthermore, monitoring of the performance of the leukoreduction process includes a quality control program based on a general statistical model with a parametric or non parametric approach, sampling plan, ongoing control, process capability assessment, confidence limit, detection of failure, and estimation of the non conforming units rate.