Study on the immunological safety of universal plasma in the Chinese population in vitro.

Background: The prepared procedure for universal plasma in the Chinese population has been developed. However, the immunological safety with the level of antibodies, soluble immune complexes and complements is necessary to investigate. Methods: The universal plasma was pooled at the optimal ratio of A:B:AB = 6:2.5:1.5 at 22 degrees C for 1 hour. The titer of IgM antibodies was detected by saline agglutination, and the titer of IgG antibodies was detected by a Polybrene test after IgM destroyed by 2-mereaptoethanol. The hemolysis extent of RBC was investigated by an extracorporal hemolysis test, and the concentration of free-hemoglobin was determined by the ortho-tolidine method. The levels of CIC-Clq, C3b and TCC (C5-9) were tested using an enzyme linked immunosorbent assay (ELISA). Results: The titer of IgM and IgG in universal plasma was lower than 2 and 4, respectively. The hemolysis of the universal plasma with A, B and AB group RBCs was negative with values of 5.5, 6.8 and 5.7, respectively. The level of CIC-C1q and TCC (C5-9) in universal plasma was comparable to that in A or B type pooled plasma, but CIC-Clq was lower than that and TCC (C5-9) was higher than that in AB type pooled plasma. The level of complement C3b was comparable to that in A type pooled plasma, but lower than that in B type pooled plasma and higher than that in AB type pooled plasma. Conclusion: The results of this study demonstrated that the immunological levels were within an acceptable range and confirmed the safety in vitro. (C) 2016 Elsevier Ltd. All rights reserved.