FDA Approves Panel of Blood-Typing Tests
Fifteen new reagents licensed for use in the United States, including tests for rare blood types
TUESDAY, Sept. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved 15 blood-typing reagents for use in analyzing donor blood. The new reagents, including several for rare blood types, had not previously been licensed for use in the United States.
The new ALBAclone Blood Grouping Reagents can be used to test for rare blood types, in addition to the more routine tests for Rh and ABO.
Manufactured by Alba Bioscience, Inc. of Durham, N.C., the reagents are monoclonal antibodies aimed at a very specific identification of type.
"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 the FDA's Center for Biologics Evaluation and Research, in a statement. "Licensure of these additional blood grouping reagents will help ensure a more stable supply of these tests, especially important in the event of a blood shortage."