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

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.