The author reflects on the impact on the inaccuracy of the human T-lymphotropic virus (anti-HTLV) testing to blood donors in the U.S. The latest generation of anti-HTLV-I/II assay was used in the retesting of the blood samples tested in 1988 which has produced different results of the previous test. This has led to the creation of orphan drug that will ensure safe blood supply from blood donors.