HTLV-I/II Serological Test Guidance

FDA has issued a guidance, Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II), to provide blood collection establishments agency recommendations on the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I and type II by blood and blood components. The document says the recommendations apply to the collection of whole blood and blood components except source plasma.

The guidance finalizes an agency 9/2018 draft guidance, supersedes recommendations specific to HTLV-I in a 7/1996 memorandum, and supersedes 11/1988 and 7/1989 memoranda and an 8/1997 guidance.

The only new recommendations in the latest guidance relate to donor requalification, FDA says. All other recommendations reflect current regulations and the availability of a licensed supplemental test for antibodies to HTLV-I/II and are otherwise consistent with previously issued recommendations.