[Study and Application of Rabbit Anti-Human CD38 Polyclonal Antibodies in Eliminating Daratumumab Interference in the Indirect Antiglobulin Test].

OBJECTIVE

To prepare rabbit anti-human CD38 polyclonal antibodies capable of masking CD38 antigens on the surface of red blood cells (RBCs), thereby eliminating the interference of daratumumab (DARA) in pretransfusion compatibility testing.

METHODS

Rabbit anti-human CD38 polyclonal antibodies were generated by immunizing New Zealand white rabbits with recombinant human CD38 extracellular domain His-tag fusion protein (hCD38-His). Antibody purity and molecular weight were assessed by SDS-PAGE. The direct antiglobulin test (DAT) was used to evaluate reactivity with antiglobulin reagents, while the indirect antiglobulin test (IAT) was applied to assess the efficacy of eliminating DARA interference and its impact on irregular antibodies detection. The effect of rabbit-derived anti-human CD38 polyclonal antibody on blood group antigen detection results was evaluated by detecting major blood group antigens on red blood cells.

RESULTS

SDS-PAGE analysis showed that the rabbit-derived anti-human CD38 polyclonal antibodies had high purity with molecular weights consistent with theoretical expectations. RBCs treated with rabbit anti-human CD38 polyclonal antibody yielded negative results in DAT, suggesting no cross-reactivity with antiglobulin reagents. IAT results demonstrated that masking RBC CD38 antigens with rabbit anti-human CD38 polyclonal antibodies effectively eliminated DARA-induced interference without compromising the detection of low-titer irregular antibodies. Furthermore, testing of major blood group antigens revealed that antibody treatment did not interfere with blood group antigen identification.

CONCLUSION

Rabbit anti-human CD38 polyclonal antibodies can stably and effectively eliminate DARA-induced interference in pretransfusion compatibility testing, without affecting the detection of RBC blood group antigens or irregular antibodies. This method is simple to operate and provides a new reliable option for clinical pretransfusion testing.