Transfusion · 2025
In vitro and in vivo evaluation of leukoreduced red blood cells after automated separation of whole blood.
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Sedjo Rebecca L, Aga Gina K, Flaumenhaft Elissa J, Stolla Moritz, Dumont Larry J, Marschner Susanne, Sutor Laurie, Compton Frances, Nestheide Shawnagay, Rugg Neeta, López Phillip, Shipps Marley, Evero Nero, Bailey S Lawrence, Byrne Daire, Gloor Christina, Leite Caroline, Cancelas Jose A, Chen Alice J
Аннотация
BACKGROUND: Leukoreduced red blood cells (LR-RBCs) prepared from whole blood (WB) with the Reveos™ Automated Blood Processing System (Reveos System) are required to meet US Food and Drug Administration (FDA) criteria for RBC component in vitro quality and in vivo 24-h RBC recovery after 42-day storage.
STUDY DESIGN AND METHODS: For the in vitro study, 65 Reveos-derived LR-RBC units were stored for 42 days in citrate phosphate dextrose (CPD)/Additive Solution Formula 5 (AS-5). Units were evaluated for post-filtration residual white blood cell (rWBC) content, post-filtration RBC recovery, and percent hemolysis at end of storage. In vivo 24-h recovery of 42-day stored autologous Reveos-derived LR-RBCs was determined in 26 healthy participants with standard single (51Cr) and dual-label (51Cr/99mTc) methods.
RESULTS: For all evaluable units processed in the in vitro study, post-filtration rWBC content was <5 × 106/RBC unit (65/65), post-filtration RBC recovery was ≥85% (63/63), and hemolysis was ≤1% after 42-day storage in AS-5 (65/65) = 100% for all parameters, one-sided 95% lower confidence limit (LCL) ≥ 95%. Single label in vivo recoveries were ≥75% in 23 of 26 infusions (95% LCL = 73%), with an average of 83% (standard deviation [SD] = 9%). When corrected by actual red cell mass, dual label in vivo recoveries were ≥75% in 24 out of 26 infusions (95% LCL = 78%) with a mean of 90% (SD = 9%).
CONCLUSION: The Reveos System met FDA's criteria for RBC component in vitro quality and in vivo 24-h recovery after 42-day storage.
STUDY DESIGN AND METHODS: For the in vitro study, 65 Reveos-derived LR-RBC units were stored for 42 days in citrate phosphate dextrose (CPD)/Additive Solution Formula 5 (AS-5). Units were evaluated for post-filtration residual white blood cell (rWBC) content, post-filtration RBC recovery, and percent hemolysis at end of storage. In vivo 24-h recovery of 42-day stored autologous Reveos-derived LR-RBCs was determined in 26 healthy participants with standard single (51Cr) and dual-label (51Cr/99mTc) methods.
RESULTS: For all evaluable units processed in the in vitro study, post-filtration rWBC content was <5 × 106/RBC unit (65/65), post-filtration RBC recovery was ≥85% (63/63), and hemolysis was ≤1% after 42-day storage in AS-5 (65/65) = 100% for all parameters, one-sided 95% lower confidence limit (LCL) ≥ 95%. Single label in vivo recoveries were ≥75% in 23 of 26 infusions (95% LCL = 73%), with an average of 83% (standard deviation [SD] = 9%). When corrected by actual red cell mass, dual label in vivo recoveries were ≥75% in 24 out of 26 infusions (95% LCL = 78%) with a mean of 90% (SD = 9%).
CONCLUSION: The Reveos System met FDA's criteria for RBC component in vitro quality and in vivo 24-h recovery after 42-day storage.