Blood Test Approved For Viruses Linked To Leukemia

The HTLV-I/II Microelisa System is intended for screening living individual human donors, including volunteer donors of whole blood and blood components for the presence of HTLV antibodies. It is also approved for testing serum and plasma specimens to screen potential organ donors when specimens are obtained while the donor’s heart is still beating. It is not intended to be used to screen cord blood specimens or cadaveric blood specimens.

Developed as a standard two-step indirect microelisa system assay, the HTLV-I/II Microelisa System contains coated 96-well microwell plates, color-coded, liquid negative and positive control. Derived from purified and inactivated HTLV-I viral lysate, a purified HTLV-II viral lysate, and a recombinant HTLV-I p21E antigen, the HTLV-I/II Microelisa System is an enzyme-linked immunosorbent assay (ELISA). The HTLV-I/II Microelisa System is manufactured by Avioq Inc., (Research Triangle Park, NC, USA). This Avioq test has received approval from the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

The Avioq HTLV-I/II assay features a user-friendly microplate design suitable for various testing volumes and automation. In addition to being used as a manual assay, the assay is also intended for use with the ORTHO Summit System (Ortho Clinical Diagnostics, Rochester, NY, USA) in the screening of blood donors. Both HTLV-I and HTLV-II can be transmitted through transfusion, reuse of syringes, and by breast-feeding from infected mothers.

Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said, "Since 2008, there has been only one FDA-licensed donor screening test available for detection of antibodies to HTLV. This approval provides an additional test for HTLV, providing greater flexibility to blood establishments and helping to assure the safety of the blood supply." Screening of all blood donors in the USA for evidence of HTLV infections is required to assure the safety of blood transfusions.

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Avioq Inc.
Ortho Clinical Diagnostics
US Food and Drug Administration