11/12 October 2022
Human T-lymphotropic viruses type I (HTLV-I) and type II (HTLV-II), also collectively referred to as HTLV-I/II, are retroviruses that can cause severe hematological and neurological diseases in infected individuals.
For this reason, FDA recommends that blood establishments use serological tests to reduce the risk of transmission by blood or blood components. These recommendations apply to the collection of Whole Blood and blood components - except for Source Plasma, which do not have to be tested by the donor facility under the current 21 CFR requirements.
In the past, the FDA has issued a number of documents to support or regulate the HTLV-I/II challenge in blood establishments:
The new document now consolidates FDA's current recommendations on HTLV-I/II as follows:
The truly new recommendations contained in this guidance document are those relating to donor requalification, which are found in Section III.B. All other suggestions reflect current regulations and the availability of a licensed supplemental test for antibodies to HTLV-I/II (anti-HTLV-I/II) and are otherwise consistent with FDA's previously published recommendations.
Further details can be found in the original document entitled "Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II)".