• Skip to main content
  • Skip to primary sidebar
Transfusion News
  • About Us
  • Topics
    • Adverse Events (non-infectious)
    • Blood Donation
    • Cell Therapy
    • Coagulation & Plasma Transfusion
    • Platelet Transfusion
    • Policy and Guidelines
    • Quality Control and Regulatory
    • RBC Transfusion
    • Serology/Genotyping
    • Special Transfusion Situations
    • Transfusion Transmitted Infections
  • Continuing Education
  • Archives
  • Podcasts
  • Question of the Day
  • Search
  • Subscribe to Email Alerts
  • Follow us on
  • Search
  • Subscribe to Email Alerts

Final FDA Guidance to Reduce Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II

February 12, 2020

Transmission of the retroviruses human T-lymphotropic virus types I and II (HTLV-I/II) require cell-to-cell contact—mother to child transmission, sexual transmission, and transmission via transfusion have all been documented.  HTLV can be asymptomatic for decades.  However, HTLV-I infection has been associated with adult T-cell leukemia/lymphoma (ATL), HTLV-associated myelopathy/tropical spastic paraparesis (HAM/TSP), and HTLV-associated uveitis; and HTLV-II has been linked to hairy cell leukemia.  Serological screening tests for HTLV-I and HTLV-II have been recommended for donated blood since 1988 and 1998, respectively.  The serological tests, however, have a high false-positive rate; ~5% of donations with reactive screening tests are confirmed positive after retesting.  The final guidance provides recommendations for donor reentry; donors may be reconsidered for reentry if one of two screening tests was indeterminate, negative, or not performed.  For a donor to reenter, a sample must be collected and screened with two tests at least 6 months after the deferral date; if both screening tests are negative, the donor may be reentered.  If one of the screening tests is positive or indeterminate, the donor must be deferred permanently.  If the donor tests reactive on one test and non-reactive on the second test, the donor must remain deferred but is eligible for one more follow-up.  Many deferred donors with unconfirmed HTLV screening tests could potentially be requalified with this final FDA guidance.

Reference:

FDA Guidance for Industry.  Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II).  February 2020.  Date Accessed February 11, 2020. 

Filed Under

  • News
  • Policy and Guidelines

Recommended

  • Variability of Blood Donor Incentives Globally

  • Clinical Predictors of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

  • VIDEO: Fresher Blood and Blood Bank Inventory Management

Show Comments

Comments on this article are closed.

Get the latest news. Subscribe to our mailing list. Sign Up

Primary Sidebar

Latest News

  • Directed Blood Donations Should be Limited

  • Babesia Infection Reduces Red Cell Deformability

  • New Erythropoietin Gene Variants Linked to Hereditary Erythrocytosis

  • Multifaceted Threats to the Blood Supply from Climate Change

    Question of the Day

    Copyright © 2025 John Wiley & Sons, Inc. All Rights Reserved.
    Privacy Policy

    Association for the Advancement of Blood and Biotherapies Wiley