Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II) Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Blood Transfusion -- standards HTLV-I Antibodies -- blood HTLV-II Antibodies -- blood HTLV-I Infections -- transmission HTLV-II Infections -- transmission We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II), collectively referred to as HTLV-I/II, by blood and blood components. These recommendations apply to the collection of Whole blood and blood components, except Source Plasma. HTLV-I/II is a relevant transfusion-transmitted infection (RTTI) (Title 21 of the Code of Federal Regulations (CFR) 630.3(h)(1)(iv)) and, therefore, subject to the testing requirements in 21 CFR 610.40, the donor deferral requirements in 21 CFR 610.41, and the donor notification requirements in 21 CFR 630.40. Blood establishments are not required to test Source Plasma for HTLV-I/II (21 CFR 610.40(a)(2)(ii)). Therefore, this guidance does not apply to the collection of Source Plasma. Silver Spring, MD : Center for Biologics Evaluation and Research, February 2020 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Technical Report Text Illustrations 1 online resource (1 PDF file (i, 13 pages)) nlm:nlmuid-101772582-pdf 101772582 http://resource.nlm.nih.gov/101772582 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0