Study On The Immune Safety Of Universal Plasma In Chinese In Vivo And In Vitro

ObjectiveThe preparation of universal plasma in Chinese population has been developed.Furthermore, the immune safety of universal plasma in vivo and in vitro is necessary to investigate. Including the titers of IgM and IgG antibodies, the hemolysis in vitro, the levels of the soluble immune complexes and complements, and animal testing.Methods1. The universal plasma was be prepared by pooling FFP with the ratio of A:B:AB ?6:2.5:1.5. The titer of IgM antibody was detected by saline agglutination, and the titer of IgG antibody was determined by a Polybrene test after IgM was destroyed by 2-mereaptoethanol.2. Firstly, the 2-4% RBC suspension of type A, type B and type AB were prepared, then added the universal plasma, type AB and type O plasma, and the water for injection(WFI), at last, the complement solution was added in to the mixture. To calculate the hemolysis (%) by the complement-mediated hemolysis test.3. To test the concentration of CIC-Clq, C3b and TCC (C5-9) by ELISA test in type A,type B and type AB pooled plasma, and the universal plasma, respectively.4. Did agglutination reaction between the universal plasma of human and red blood cell of mice in vitro and observed whether the universal plasma would induce hemolysis in vivo.Results1. The titer of IgM antibody of the universal plasma was ?2, and the titer of IgG antibody of the universal plasma was ?4.2. The heomolysis (%) of the universal plasma with A, B and AB type RBC was negative with the values of 5.5, 6.8 and 5.7, respectively.3. The level of CIC-Clq in universal plasma was comparable to that found in A and B type pooled plasma, but was significantly lower than that found in AB type pooled plasma. The concentration of complement C3b in universal plasma was comparable to that found in A type pooled plasma, but was significantly lower than that in B type pooled plasma and higher than that in AB type pooled plasma. The concentrations of TCC (C5-9) in universal plasma was comparable to that found in A and B type pooled plasma, but was significantly higher than that in AB type pooled plasma.4. Strong agglutination reaction between the universal plasma of human and red blood cell of mice in vitro, but no hemolysis in vivo.ConclusionsThe levels of the IgM and IgG antibodies were both lower than two exiting products in abroad. The low levels of the soluble immune complexes and complements in the universal plasma, and did not induce complement-mediated hemolysis of RBC in vitro and in vivo. All the results demonstrated the immunological safety and provided important evidence for preparation of the universal plasma to Chinese population.