The U.S. Food and Drug Administration today licensed 15 new blood
typing tests that were previously unavailable in the United States.
These tests, known as blood grouping reagents, are used to
determine the blood type of blood donors, an essential step in
ensuring safe blood transfusion for patients. If mismatched blood is
administered to a patient, it may cause a serious and potentially
fatal reaction. To prevent such problems, people must receive
compatible blood based on the results of blood typing tests.
The newly approved ALBAclone Blood Grouping Reagents include the
common ABO and Rh tests, plus tests for rare blood types. The
reagents are monoclonal antibodies, highly specific antibodies that
ensure product uniformity and availability.
"The licensing of these reagents will provide more choice for
blood establishments and transfusion services and may facilitate
testing for rare blood groups," said Jesse L. Goodman, M.D., M.P.H.,
director of FDA's Center for Biologics Evaluation and Research.
"Licensure of these additional blood grouping reagents will help
ensure a more stable supply of these tests, especially important in
the event of a product shortage."
The reagents are manufactured by Alba Bioscience, Inc. of Durham,