Public health agency The US Food and Drug Administration on Thursday authorised the approval of ID CORE XT to help determine blood compatibility for use in transfusion medicine.

This US FDA's approval of the ID CORE XT Test was granted to Progenika Biopharma SA, a Grifols company.

The company's ID CORE XT, a molecular-based assay, can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. This is the second molecular assay approved for use in transfusion medicine and the first to report genotypes as final results.

According to the agency, the human blood can be classified into different groups based on the antigens on the red blood cells. The presence or absence of other specific blood group antigens can be important when matching blood for transfusions since some people develop antibodies to non-ABO antigens. If red blood cells with poorly matched non-ABO antigens are transfused, red blood cell destruction and a transfusion reaction can occur in a transfusion recipient, including sickle cell disease.

Traditionally, the red blood cell antigens have been identified using serological methods that involve the use of antisera, a blood serum that contains antibodies for testing. Serologic testing presents limitations and certain antisera may be scarce or unavailable, stated the agency.

In conjunction, a study was conducted to compare the typing results of the ID CORE XT Test with licensed serological reagents, the first US FDA-approved molecular assay and DNA sequencing tests. The results demonstrated comparable performance between the methods.