Development of Cryopreserved Red Blood Cell Panels as Biological Reference Standards for Performance Evaluation of ABO and D Blood Grouping Reagents

Abstract

Background: Accurate blood typing is essential for blood transfusions, and requires the constant evaluation and maintenance of ABO and D blood grouping reagents. In the present study, we developed cryopreserved red blood cell (RBC) panels and evaluated their feasibility as a stan- dard reference material to verify the quality of ABO and D blood grouping reagents in Korea. Methods: RBC units obtained from healthy donors were cryopreserved using a high-glycerol method. A total of 400 sets of RBC panels were pre- pared, composed of blood group A (N = 5), B (N = 5), O (N = 10), AB (N = 4), Rh D-positive (N = 4), Rh D-negative (N = 5), and weak-D (N = 1), and 200 sets of RBC subgroup panels composed of A2, A2B, A2B3, A1B3, and B3, and A2, A2B, A2B3, A1B3, and A3B (N = 1, each). Quality assessment of the cryopreserved RBC panels before and after cryopreservation was performed by measuring their sensitivity, specificity, avidity, and potency titers. Results: Our cryopreserved ABO and D RBC panels had a sensitivity and specificity of 100% to existing monoclonal blood grouping reagents, re- gardless of blood type and cryopreservation time. There were no significant differences in the avidity time and potency titers of the cryopreserved RBCs before and after 6 or 12 months of cryopreservation. Conclusions: The quality parameters measured here suggest that our newly developed cryopreserved RBC panels were reliable for use as a standard reference material for the performance evaluation of anti-A, -B, and -D blood grouping reagents.