FDA: 15 New Blood Typing Tests Licensed

The U.S. Food and Drug Administration (FDA) licensed 15 new blood typing tests that were previously unavailable in the United States.

According to the FDA, the tests, known as blood grouping reagents, are used to determine the blood type of blood donors, an essential step in ensuring safe blood transfusions and organ donations for patients.

There are four blood types in the ABO blood group: A, B, AB, and O. These blood types are determined by a substance called agglutinogen that is present on the outside of the patient's red blood cells. Patients who have type AB blood are considered universal recipients because they can receive blood or blood products from any other blood type. However, these patients may only donate their blood to patients who have AB blood. Patients who have O blood are considered the universal donors because they can give blood to patients of any other blood type. However, they can only receive blood from patients who have O blood.

In addition, patients have either positive or negative blood. Patients who have a protein called D antigen on their red blood cells are considered Rh-positive. If the D antigen is absent, the patient is Rh-negative. For instance, if a patient has type A agglutinogen but no D antigen, he/she has type A-negative blood.

If mismatched blood is administered to a patient, it may cause a serious and potentially fatal reaction. To prevent such problems, people must receive compatible blood based on the results of blood typing tests.

The newly approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, plus tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity and availability.

The FDA hopes that the licensing of these reagents will provide more choice for blood establishments and transfusion services and help facilitate testing for rare blood groups.

The reagents are manufactured by Alba Bioscience, Inc. of Durham, North Carolina

Comments

[Benson]

What are these rare blood types that the new tests can detect? Are there other rare antigens that previously could not be tested for?

[dalz]

What are rare blood types? I would like to know exactly how the new FDA-approved ALBAclone Blood Grouping Reagents will help to facilitate this testing. It’s good to see that advances are being made to help intercept preventable health disasters from occurring.

[Gary]

It's good that these tests are now available to ensure safer blood transfusions. I am surprised that these tests were just introduced though. I guess I assumed that the blood testing that was being used for transfusions was not likely to produce error. Anyone know more about this?

[Michelle]

What makes these new tests any better than the ones we currently have?

[CR]

How do they normally type your blood? I know when I've gone to donate blood before, they may not know at the time when I'm donating what type I am (O-) but I think it is on the donor card they send in the mail to me after donating blood. Were the previous tests FDA approved?

[W Thomas]

I am curious also about these rare blood types that this new testing detects. I searched the FDA Web site, but found no answers. (Their search engine is among the worst!) I also did a quick Google search but did not find any information that elaborated on the actual blood types. If anyone out there has any ideas about this, do fill us in!

[WeddedOne]

Check out http://www.bloodbook.com/rare.html for more info about rare blood types. Here's some of their info:
All blood belongs to a major group: A, B, AB or O. However, there are more than two hundred minor blood groups that can complicate blood transfusions. About one person out of 1,000 inherits a rare Blood type. To further define and clarify rare blood, there are more than 600 known antigens besides A and B that identify the proteins found on a person's red blood cells. A person's blood type is considered as very rare if only one person out of 10,000 has or lacks similar blood antigens.

[Tomlin]

So, can people buy these blood tests and find out what their type is at home?

[Gary]

How can I find out what type of blood I have? Do I have to donate blood, or will my doctor know?

[Thomas]

Isn't there a blood type that can be dangerous when a woman has a baby? I think if the mom is Rh- and the fetus is Rh+ it can cause antibodies to form or something. Does anyone know about this, or am I completely wrong?

[Steve]

Thomas,

Mother-fetus incompatibility occurs when the mother is Rh- and the father is Rh+. This may cause maternal antibodies to cross the placenta and destroy fetal red blood cells. The risk increases with each pregnancy. In the United States, about one out of 1,000 babies are born with this condition. Although mother-fetus incompatibility is considered the leading cause of potentially fatal blood-related problems in newborns, treatment can help reduce this risk to less than one percent.

[April]

Are we having serious problems with our current blood typing systems that make this multitude of new types necessary?

[jason]

Will this new test be standard now? Is it more costly than what is currently used?