Infectious Disease Testing

A set of tests to screen for potential (“relevant,” to use FDA terminology) transfusion-transmitted diseases required for every allogeneic blood donor. These are the currently required tests (as of the FDA’s finalized guidance regarding Babesia testing in May 2019):

Several things to note from this list:

• While I have simplified things by writing “EIA” by many of these tests, they are also performed by using chemiluminescence testing (ChLIA) rather than enzyme immunoassay.
• We perform three tests for hepatitis B detection.
• Six of the diseases are detected (at least in part) by nucleic acid testing: HIV, HCV, HBV, West Nile Virus, Zika Virus, and Babesia.
• The “*” by anti-T.cruzi testing is because that is the only test that is only required ONCE in a U.S. donor’s entire lifetime!
• Finally, the second “*” by Babesia testing is due to the fact that such testing is only required in 14 U.S. states plus Washington DC (see the FDA guidance for the complete list).

Those studying for exams should be aware of all of these tests, and the type of technology used (for example, NAT vs EIA/ChLIA).