U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. Alinity s HTLV I/ll
  1. Approved Blood Products

Alinity s HTLV I/ll

STN: 125675
Proper Name: Human T-Lymphotropic Virus Types I and II (E coli, Recombinant) Antigen and Synthetic Peptides
Tradename: Alinity s HTLV I/II
Manufacturer: Abbott GmbH & Co. KG
Indication:

  • The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System. The Alinity s HTLV I/II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti‑HTLV I/HTLV II. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.

Product Information

Supporting Documents

Back to Top