The United States Food and Drug Administration (FDA) approved the ID CORE XT, a molecular assay that, in medicine, is used in blood transfusions to help determine blood compatibility. The assay can be used to determine if there is an ABO incompatibility between the red blood cells of the blood donors and the patients. The ID CORE XT Test is the second molecular assay approved for use in transfusion medicine, and the first to yield genotypes as definitive results.

“Passage of the ID CORE XT test can simplify blood compatibility testing and offers an additional alternative to antisera blood testing,” said Peter Marks, MD, Ph.D., director of the Center for Evaluation and Research of Biologicals of the FDA. “We know that DNA testing is very promising: providing more informative, accurate and cost-effective methods that can improve patient care.”

What is this test?

The test allows to simultaneously determine 37 antigens of 10 blood groups in less than four hours from a DNA sample. The typing of blood groups at the molecular level used by ID CORE XT offers greater safety in blood transfusion, ensuring greater compatibility between donor and patient, and facilitating a correct typing in those cases in which conventional techniques are insufficient, such as in patients transfused recently or when it is important to identify antigens for which there are no commercial antibodies.

Human blood can be classified into different groups according to the antigens on the surfaces of red blood cells. In addition to ABO blood group antigens, the presence or absence of other blood group-specific antigens may be important when combining blood for transfusions, as some people develop antibodies against non-ABO antigens. People who receive repeated blood transfusions, such as people with sickle cell disease, are more likely to develop these antibodies. If red blood cells are transfused with antigens whose ABO compatibility does not match, there may be a destruction of red blood cells and a reaction to transfusion in the recipient.

People who have a blood type can form antibodies that cause the immune system to react against one or more of the other types of blood.

The fact of being exposed to another type of blood can cause a reaction. This is important when someone needs to receive a transfusion or an organ transplant. Blood types must be compatible to avoid a reaction due to ABO incompatibility.

For example:

– People with blood type A will react against blood type B or AB.

– People with blood type B will react against blood type A or AB.

– People with blood type O will react against blood types A, B or AB.

– People with blood type AB will not react against blood types A, B, AB or type O.

Blood type O does not cause an immune response when it is received by people with blood type A, B or AB. This is the reason why blood type O cells can be given to people of any blood type. People with blood type O are called universal donors.

A study was conducted to compare the typing results of the I ID CORE XT test with authorized serological reagents, the first molecular assay approved by the FDA and the DNA sequencing tests. The results showed a comparable performance between the methods.

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