DNA-based test for blood compatibilityJanuary 14, 2019
The US FDA approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility.
The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results, according Progenika Biopharma S.A. a Grifols company.
Traditionally, 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.
A study was conducted to compare the typing results of the ID CORE XT Test with licensed serological reagents, the first FDA-approved molecular assay, and DNA sequencing tests. The results demonstrated comparable performance between the methods.