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

Abstract

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.

Validation of the Sysmex XN analyser and Blood Bank mode for the quality and safety of donor blood and transfusion products

“…Blanco et al showed that rWBC had a mean limit of quantification of 0.002 × 10 9 WBC/L and a good correlation between observed and expected results in linearity studies 6 . Finally, Cavagnetto et al, showed in similar study, this time focusing on rRBC, that the Blood Bank mode had a good correlation between observed and expected results and that the results were consistent with the FC analysis 11 . In our study, the pool of blood donors and blood products came from a single centre, and the number of samples in the different blood products ranged from nine to 55.…”

“…showed in similar study, this time focusing on rRBC, that the Blood Bank mode had a good correlation between observed and expected results and that the results were consistent with the FC analysis. 11 In our study, the pool of blood donors and blood products came from a single centre, and the number of samples in the different blood products ranged from nine to 55. In addition, we did not find any samples with residual cells above the safety limits or the LoQ of microscopic examination, so a direct comparison between these two methods was ultimately not possible.…”

International Forum on Policies and Practice for Transfusion of ABO and RhD Non‐Identical Platelets: Summary

“…Intact red cells are known to be generally present at lower levels in apheresis compared to whole blood derived platelets [4,32]. Contaminating red cell levels in buffy-coat derived platelets have been demonstrated to be substantially lower in platelets prepared using automated TACSI method compared to semi-automated [33]. Interestingly, France was the only respondent that routinely used TACSI to produce their whole blood derived platelets (70% of their supply), yet the rate of alloimmunisation for D mismatched platelets observed (1%) appears to be similar to other studies [25].…”

Anti‐D immunization after D positive platelet transfusions in D negative recipients: A systematic review and meta‐analysis

“…7,8 In general, WBD platelet products have a higher level of contaminating RBCs in comparison with APC platelet products. 9,10 Immunization to RBC antigens poses a variety of complications especially in patients requiring frequent blood transfusion, including difficulty locating compatible blood products and delayed hemolytic transfusion reactions (DHTR) in future transfusions, caused by an anamnestic response of the immune system. 11 Although most DHTR are reported in the context of RBC transfusions, it may also occur after platelet transfusions.…”

“…In low‐income countries, almost all platelet products are WBD (platelet‐rich plasma method), as donor platelet collection by apheresis is not available 7,8 . In general, WBD platelet products have a higher level of contaminating RBCs in comparison with APC platelet products 9,10 . Immunization to RBC antigens poses a variety of complications especially in patients requiring frequent blood transfusion, including difficulty locating compatible blood products and delayed hemolytic transfusion reactions (DHTR) in future transfusions, caused by an anamnestic response of the immune system 11 .…”