In August 2010, ECDC was asked by the European Commission to assess the epidemiological history of Human T-lymphotropic Virus (HTLV), possible risks of HTLV transmission through transplantation of human tissues and cells, and possible measures to prevent such transmission.
ECDC’s ad hoc expert panel considered the US classification used to decide which cell and tissue types should be tested is insufficient to remove the risk of HTLV transmission. Similarly, claims that tissue and cell processing remove the risk were considered difficult to evaluate without transparent validation.
The ECDC ad hoc expert panel concluded that donor selection by risk factor exclusion is an inefficient strategy for reducing transmission risk and that donor review should not replace HTLV-I/II testing, particularly in the case of donors originating from endemic regions.
The review shows that tests are available which, if they received FDA approval, would be technically suitable for testing tissue donations, as illustrated by the fact that they are used in Europe and other parts of the world.
The first part of this report, entitled Risk assessment of HTLV-I/II transmission by tissue/cell transplantation Part 1: Epidemiological review was published in April 2012.