> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# HTLV-I/II Serological Test Guidance
- URL: https://www.fdaweb.com/htlv-i-ii-serological-test-guidance/
- Published: 2020-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:01:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146015

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](https://www.fda.gov/media/124062/download?ref=fdaweb.com) 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The guidance finalizes an agency 9/2018 draft guidance, supersedes recommendations specific to HTLV-I in a 7/1996 memorandum, and supersedes 11/1988 and 7/1989 memoranda and an 8/1997 guidance.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.