Residual red cells in blood components: A multisite study of fully automated enumeration using a hematology analyzer.

BACKGROUND: Manufacture of platelet concentrates (PCs) and plasma may fail to remove all residual red blood cells (rRBCs). Measuring rRBCs for compliance to guidelines has proven challenging, leading to an absence of a consensus methodology. Sysmex hematology analyzers with the Blood Bank mode (BB mode) analysis option offer the potential for automated rRBC counting. We therefore performed a two-site appraisal of the system. STUDY DESIGN AND METHODS: Performance characteristics were determined using platelet and plasma samples spiked with RBCs. Sample stability (n = 47) and the impact of sample type were also assessed. Components (platelets, n = 1474; plasma, n = 77) prepared using different routine manufacturing methods were tested to assess variation in rRBC concentration. RESULTS: Linearity studies up to 19 000 RBCs/µL demonstrated good correlation between expected and observed results (R2 ≥ 0.9731), and flow cytometric results also correlated well with BB mode (R2 = 0.9400). Precision analysis gave a limit of quantitation of 6 to 7 RBCs/µL, and carryover was 0.03%. Ethylenediaminetetraacetic acid and plain tube results were not significantly different (P ≥ 0.10), and samples were stable up to 24 hours. Apheresis PCs produced at two sites had lower rRBC concentrations (medians, 17 and 13 RBCs/µL) than those produced with the buffy coat method either manually (median, 681 RBCs/µL) or with the automated Terumo Automated Centrifuge and Separator Integration process (median, 81 RBCs/µL). All PCs failing visual inspection as having RBCs ≥4000 RBCs/µL were also detected by the BB mode. CONCLUSION: The BB mode had acceptable performance characteristics and has the potential for integration into a fully automated process control system for rRBC enumeration in plasma and PCs.

The use of a hematology analyzer with a new generation of software as an alternative to flow cytometry for enumerating residual white blood cells in blood components.

BACKGROUND: Leukoreduction of blood components was implemented to reduce transfusion-associated risks. The detection level for residual white blood cells (rWBCs) required to demonstrate leukoreduction was originally considered too low for hematology analyzers. Developments enabling cell counts in body fluids have, however, renewed interest in rWBC counting. An assessment of Sysmex XN hematology analyzers with software offering automated rWBC enumeration intended for use on blood components was performed. STUDY DESIGN AND METHODS: Performance characteristics were determined using platelet, red blood cell (RBC), and plasma samples spiked with WBCs. Subsequently, components (platelets, n = 1367; and plasma, n = 80) were tested and results compared with flow cytometry, to monitor leukoreduction efficiency to a level of less than 1 × 106 /unit. Components identified by flow cytometry as having poor leukoreduction, exceeding this limit, were also tested (platelets, n = 3; and RBCs, n = 10). RESULTS: Linearity studies up to 32 WBCs/µL showed good correlation between observed and expected results (R2 > 0.9996). Precision analysis gave an average limit of quantitation of 2 WBCs/µL with coefficients of variation less than 20%. Average carryover was 0.1%. Plain sample tubes were a source of aberrant results with routine components. Using ethylenediaminetetraacetic acid tubes the analyzer gave results greater than 1 × 106 /unit in 2.7% of cases compared with 1.4% by flow cytometry, but overall results were within specification, with more than 90% of components having rWBC values below the limit. All incidences of poor leukoreduction, with flow cytometry results greater than 13 rWBCs/µL were correctly identified, with an excellent correlation between results (R2 = 0.9818). CONCLUSION: The analyzer demonstrated acceptable performance characteristics for enumeration of rWBCs; consequently, additional multisite evaluations are warranted.