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. 2025 Nov;65(11):2144-2152.
doi: 10.1111/trf.18427. Epub 2025 Oct 21.

In vitro and in vivo evaluation of leukoreduced red blood cells after automated separation of whole blood

Rebecca L Sedjo  1 , Gina K Aga  2 , Elissa J Flaumenhaft  2 , Moritz Stolla  3 , Larry J Dumont  4 , Susanne Marschner  4 , Laurie Sutor  5 , Frances Compton  5 , Shawnagay Nestheide  6 , Neeta Rugg  6 , Phillip López  1 , Marley Shipps  1 , Nero Evero  1 , S Lawrence Bailey  3 , Daire Byrne  3 , Christina Gloor  2 , Caroline Leite  4 , Jose A Cancelas  6   7 , Alice J Chen  2
Affiliations

In vitro and in vivo evaluation of leukoreduced red blood cells after automated separation of whole blood

Rebecca L Sedjo et al. Transfusion. 2025 Nov.

Abstract

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.

Keywords: Reveos; automated blood component processing; hemolysis; leukoreduced RBC; red blood cell in vivo recovery.

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References

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