Human Tissue Authority

The regulator for human tissue and organs

Human T-lymphotropic virus testing

Issue date: 
29 January 2015

In 2012 the HTA successfully negotiated with the EU Commission an amendment to the wording of the testing requirements for human T-lymphotropic virus (HTLV). This amendment has been implemented into UK law by the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014

This change followed a recommendation to the EU Commission by the European Centre for Disease Control (ECDC) and was to replace 'high-incidence' with 'high-prevalence' so that: ‘HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’.

The Regulations came into force on the 15 December 2014. All licensed establishments in the human application sector involved in donor testing should ensure that they are now working to this amendment. The term ‘high incidence’ should no longer be used when identifying donors to which the HTLV testing requirement applies and should be replaced by the term ‘high prevalence’. ECDC has informed us that it will maintain prevalence data on its website and we will signpost this when it becomes available.


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