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ANNEX II U.K.LABORATORY TESTS REQUIRED FOR DONORS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 4(1)

1. Biological tests required for donors U.K.

1.1. The following biological tests must be performed for all donors as a minimum requirement: U.K.

HIV 1 and 2	Anti-HIV-1,2
Hepatitis B	HBsAg Anti HBc
Hepatitis C	Anti-HCV-Ab
Syphilis	See 1.4 (below)

[F1 1.2. 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.] U.K.

Textual Amendments

F1 Substituted by Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells (Text with EEA relevance).

1.3. When anti-HBc is positive and HBsAg is negative, further investigations are necessary with a risk assessment to determine eligibility for clinical use. U.K.

1.4. A validated testing algorithm must be applied to exclude the presence of active infection with Treponema pallidum. A non-reactive test, specific or non-specific, can allow tissues and cells to be released. When a non-specific test is performed, a reactive result will not prevent procurement or release if a specific Treponema confirmatory test is non-reactive. A donor whose specimen tests reactive on a Treponema-specific test will require a thorough risk assessment to determine eligibility for clinical use. U.K.

1.5. In certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the tissue or cells donated (e.g. RhD, HLA, malaria, CMV, toxoplasma, EBV, Trypanosoma cruzi). U.K.

1.6. For autologous donors, Annex I, point 2.1.1, applies. U.K.