New Product Helps Prevent Destruction of Red Blood Cells Following Transfusion

The FDA has announced its approval of the Immucor Precise Type Human Erythrocyte Antigen (HEA) Molecular BeadChip test, the first molecular assay approved for use to assist in determining the compatibility of blood in transfusions, according to a press release. The product, which can be used to identify non-ABO/non-RhD (non-ABO) red blood cell types in the donor and the patient, will help the prevent the development of antibodies to non-ABO antigens following transfusion or pregnancy.

When blood used in transfusions is improperly matched, patients such as those receiving frequent blood transfusions or those with sickle cell disease can develop antibodies that destroy red blood cells containing corresponding antigens. The assays can help to select blood better matched to patients’ non-ABO antigens to prevent the development of corresponding antibodies. If a patient already houses an antibody that causes the destruction of red blood cells, the assays can—using coded beads that generate light signals, which are decoded by computer software—help identify red blood cells that are negative for the corresponding antigen. Previously, access to such tests was limited because of the scarcity or unavailability of antisera specific to the antigens for which the blood is being tested.

“The approval of the Immucor PreciseType HEA Molecular BeadChip Test provides an alternative to serological typing and may enhance patient care in certain situations,” said FDA Center for Biologics Evaluation and Research Director Karen Midthun, MD. The product, manufactured by BioArray Solutions Ltd., was found to be safe and effective for its intended use by the FDA’s Blood Products Advisory Committee.