Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
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.
Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2020
Language(s):
English
Format:
Text
Subject(s):
Blood Transfusion -- standards
HTLV-I Antibodies -- blood
HTLV-II Antibodies -- blood
HTLV-I Infections -- transmission
HTLV-II Infections -- transmission
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (i, 13 pages))
Illustrations:
Illustrations
NLM Unique ID:
101772582 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772582