FDA approves first molecular test to determine RBC types in transfusion medicine
The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test — the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States. The surfaces of red blood cells display minor blood group antigens in addition to the major ABO blood group antigens. Some people develop antibodies to non-ABO antigens following transfusion or pregnancy. This is especially true in people who may receive repeated blood transfusions, such as those with sickle cell disease. The development of such antibodies can cause red blood cell destruction if red blood cells with the corresponding antigens are later transfused. Development of antibodies to non-ABO antigens can be prevented by selecting blood that is better matched to the patient‘s non-ABO antigens. In additio