FDA Licenses 14 New Blood-Typing Tests to Help Ensure Safe Transfusions

Article

On Jan. 10, the Food and Drug Administration (FDA) licensed 14 new tests for determining a person's blood type, a process essential to a safe U.S. blood supply and safe transfusions.

"These 14 new tests will provide blood establishments and transfusion services with additional choices to help assure safe, well-matched transfusions," said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "The tests offer a broader diversity of reliable blood-typing tests and will help protect against product shortages."

Knowing the blood types for blood donors and patients is critical; patients may experience serious, possibly life-threatening reactions from mismatched transfused blood. The most familiar blood types are A, B, O, and Rh.

The OLYMPUS PK System Blood Group and Phenotyping Reagents use monoclonal antibodies to test for the A, B, O, and Rh factors as well as for other factors that signify a rarer blood type.

Monoclonal antibodies, which are proteins produced in a laboratory from genetically identical cells, have the ability to bind to and detect a specific substance, such as the proteins used in blood typing.

The tests are manufactured by DIAGAST of Loos Cedex, France.

Source: FDA

Recent Videos
Pathogen Playbook Presenter: Sharon Ward-Fore, BS, MS, MT(ASCP), CIC, FAPIC
Mark Wiencek, PhD
Rebecca Crapanzano-Sigafoos, DrPH, CIC, AL-CIP, FAPIC
The CDC’s updated hospital respiratory reporting requirement has added new layers of responsibility for infection preventionists. Karen Jones, MPH, RN, CIC, FAPIC, clinical program manager at Wolters Kluwer, breaks down what it means and how IPs can adapt.
Studying for the CIC using a digital tablet and computer (Adobe Stock 335828989 by NIKCOA)
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Cheron Rojo, BS, FCS, CHL,  CER, CFER, CRCST
Matthias Tschoerner, Dr Sc
Standardizing Cleaning and Disinfection
Related Content