FDA Approves DNA-Based Blood Compatibility Test

The U.S. Food and Drug Administration (FDA) has approved ID CORE XT, a molecular-based assay that can be used to determine blood donor and patient compatibility.

FDA approval of the test was based on results of a study showing that the test performed comparably to antisera-based methods.

Human blood is classified based on the antigens on the surface of red blood cells, including the ABO blood group antigens and non-ABO antigens, which are more likely to be developed in patients who receive multiple blood transfusions. When these patients, such as those with sickle cell disease, receive blood transfusions with poorly matched non-ABO antigens, cell destruction and a transfusion reaction are likely to occur.

Non-ABO antigens have traditionally been identified by testing antisera, a blood serum containing antibodies. However, when antisera is scarce or unavailable, performing this type of testing is difficult, creating the need for alternative testing methods like DNA analysis.

The ID CORE XT test is the second molecular assay approved for transfusion medicine, and the first to report genotypes as final results.

Source: FDA news release, October 11, 2018.