Thefor use in transfusion.
It’s the second molecular test for blood compatibility but the first to report genotype in its results, according to anfrom the agency.
The test is important because it evaluates patients – especially those who receive repeated blood transfusions for conditions such as sickle cell anemia – for non-ABO antigens, but it does so without using antisera, which is sometimes unavailable.
A study found comparable performance between the ID CORE XT, licensed serologic reagents, and DNA sequencing tests, according to the FDA.
The ID CORE XT test is marketed by Progenika Biopharma, a Grifols company.
More information can be found in the full FDA.