Avioq announced that the Avioq® HTLV-I/II Microelisa System assay has obtained Health Canada approval and can now be used for testing blood specimens from deceased (cadaveric, non-heart beating) organ and tissue donors.
The new claims allow for pre-transplantation serum or plasma testing of living as well as deceased organ and tissue donors, thereby protecting transplant recipients from donation-related transmission of HTLV-I/II.
"Testing of donors prior to organ and tissue transplant with the HTLV-I/II Microelisa System allows healthcare professionals to provide an increased level of safety for transplant recipients," said Dr. Chamroen Chetty, CEO of Avioq.
The expanded HTLV-I/II Microelisa System claim now allows rapid testing to meet the urgent nature of organ and tissue transplant procedures from deceased donors.
HTLV-I is a human type C retrovirus which has been etiologically associated with Adult T-Cell Leukemia (ATL) and with a demyelinating neurologic disorder termed Tropical Spastic Paraparesis, and/or HTLV-I Associated Myelopathy (TSP/HAM).
Antibodies to HTLV-I are found with high frequency in persons affected with these disorders. HTLV-I is endemic in some Caribbean countries, southern Japan, and possibly in some areas of Africa.
In the United States, HTLV-I has been identified in ATL patients, intravenous drug abusers, and in healthy individuals. HTLV-II has not been definitively linked to human illness but has been isolated from patients with a rare T-cell leukemia.