The U.S. Food and Drug Administration (FDA) approved ID CORE XT, a molecular-based assay that 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 blood transfusions, but it is the first to report genotypes as final results.
The decision was based on results from a study that compared 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,” according to an FDA press release.
"The ID CORE XT assay performed as a reliable and accurate method for correctly predicting red blood cell phenotypes of clinically relevant blood group antigens," wrote authors of a study testing the newly #FDA-approved blood compatibility test.https://t.co/2nfs0tPRTx
— HCPLive (@MDMagazine) October 11, 2018
Human blood can be classified based on the surface antigens of RBCs. The presence or absence of specific blood group antigens, other than ABO, can be important when matching blood for transfusions, as some patients can develop antibodies to non-ABO antigens. Those who receive repeated blood transfusions, such as patients with sickle cell disease, are more likely to develop these antibodies, which can lead to RBC destruction and cause transfusion reactions.
— David Lozano (@davlozmar) October 15, 2018
Traditionally, RBC antigens have been identified using serological typing that involves the use of blood serum that contains antibodies for testing (antisera). But serologic testing has limitations and certain antisera may be scarce or unavailable, according to the FDA. This new approval can “streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” according to the FDA press release.