Monoclonal Antibodies Determine Donor Blood Type

Tests are essential for determining the blood type of blood donors, thus ensuring safe blood transfusions 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.

Fifteen new blood typing tests that were previously unavailable in the United States have been licensed by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA). These 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. Called ALBAclone blood grouping reagents, they are manufactured by Alba Bioscience, Inc. (Edinburgh, UK).

"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.”


Related Links:
U.S. Food and Drug Administration
Alba Bioscience