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Coombs crossmatch using gel: immediate spin too?
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4/7/2016 at 4:30:17 AM GMT
Posts: 9
Coombs crossmatch using gel: immediate spin too?

From a CBBS Member:

If a Coombs crossmatch is performed on an FDA-approved automated gel platform (ProVue, Vision, or Erytra), in a transfusion service which has a validated computer system to determine ABO incompatibility, would an immediate spin serologic crossmatch also be required before issuing blood? Or can the computer check inherent to the issue process be used for ABO compatibility check in lieu of the immediate spin crossmatch?



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4/15/2016 at 4:47:49 PM GMT
Posts: 9

From the CBBS Editors:

This topic was the subject of an AABB ask the FDA session from 2010 and Ms. Meyers the representative from CMS gave a thorough answer here:

http://tinyurl.com/l2pv8ae

“The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients.”

We added the yellow highlighted statement.  Bottom line, the gel crossmatch by itself is not sufficient to ensure ABO compatibility and an additional test is needed.  However, that test may be an electronic crossmatch for eligible patients and with appropriate validation. At two of our hospitals, we use the gel crossmatch along with an electronic computer crossmatch and do not perform an additional immediate spin tube test. 



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Last edited Friday, March 24, 2017
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