Ministry of Health: Institute for Transplantation and Biomedicine / Colour key VIRAL HIV 1 and HIV 2 Hepatitis B Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended Legy binding Non-reproductive tissues and cells Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT YES N/A NAT is mandatory for donors. HBs Ag YES N/A Anti-HBc YES N/A Anti - HBs YES N/A If there are anti-hbcpositive and HbsAg negative donors, in the framework of risk assessment, for the donor assessment it is necessary to provide anti-hbs with titers. Tissue of donors with titers higher than 100 U /l and negative NAT can be used. If there is no possibility to provide NAT and tissues of ogeneic living donors are stored for a longer period, it is necessary to take samples and repeat after 180 days. Hepatitis C HBV NAT YES N/A NAT is mandatory for donors. Anti-HCV YES N/A HCV NAT YES N/A NAT is mandatory for donors. 1 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Ministry of Health: Institute for Transplantation and Biomedicine / HTLV-1 Legy binding Technique not specified YES N/A The have to be performed if the donor/the donor's sexual partner/parents of the donor are living in or orginating from an area with a high prevalence for HTLV Anti-HTLV-1 YES N/A donors living in or originating from a high prevalence area, or parents or sexual partners originating from those areas HTLV-2 Chikungunya virus Cytomegalovirus Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum HTLV-1 NAT Technique not specified YES N/A N/A additional such as CMV test may be required depending on the donor s medical history and the 2 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Ministry of Health: Institute for Transplantation and Biomedicine / (Syphilis) Legy binding Anti-T. pidum YES N/A For donors positive on Treponema-specific test, risk assessment is required to determine eligibility of specific tissue for use. Microscopy T. pidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform Other Tests ABO blood group RhD blood group HLA additional such as ABO may be required depending on the donor s medical history and the characteristics of the tissue and cells donated. RhD may be required depending on the donor s medical history and the characteristics of the tissue and cells donated. depending on donor history and tissues characteristics, additional such as HLA antibodies and antigens may be required. Genetic, please specify condition 3 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Ministry of Health - Institute for Treansplantation and Biomedicine / Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding More stringent - recommended Not legy binding and not recommended VIRAL HIV 1 and HIV 2 Legy binding Reproductive tissues and cells Anti-HIV 1 YES N/A ( both partner and non-partner donation) Anti-HIV 2 YES N/A ( both partner and non-partner donation) Hepatitis B HIV 1p24 HIV NAT Ag HIV HBs Ag YES N/A Anti-HBc YES N/A Hepatitis C Anti - HBs HBV NAT Anti-HCV YES N/A Mandatory for both partner and nonpartner donation HTLV-1 HCV NAT Technique not specified Anti-HTLV-1 YES N/A Anti-HTLV 1 is mandatory for donors living in or coming from areas with high prevalence of HTLV or whose sexual partners or parents live or originate from areas with high prevalence of HTLV-1 HTLV-1 NAT 4 of 6 2. REPRODUCTIVE T&C 30/06/2016
Ministry of Health - Institute for Treansplantation and Biomedicine / Legy binding HTLV-2 Anti HTLV 2 as additional test for partner donation may be required in case travels or exposure to the risk of contagion, or depending on the characteristics of the procured reproductive cells. Chikungunya virus Cytomegalovirus Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Additional such as CMV may be required depending on the exposure to the risk of infection or characteristics of procured reproductive cells. Additional on Dengue virus may be required depending on the donor travels or exposure to the rsisk of contaign, and depending on the characteristics of procured reproductive cells. Testing for VEB may be reguired depending on travels or exposure to the risk of contagion, or Testing for malaria may be required depending on travel history or exposure to the risk of contagion, or depending on the characteristics of the procured reproductive cells. Testing for toxoplasmosis may be required depending on travels or Testing for Trypanosoma may be required depending on travels or exposure to the risk of contagion, or depending on the characteristics 5 of 6 2. REPRODUCTIVE T&C 30/06/2016
Ministry of Health - Institute for Treansplantation and Biomedicine / Legy binding Treponema pidum (Syphilis) Technique not specified YES N/A Serological markers of non-partner donors for syphilis have to be negative. Chlamydia trachomatis Anti-T. pidum Microscopy T. pidum NAT Technique not specified C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES N/A In non-partner donation sperm donors must be negative for Chlamydia on a urine sample tested by NAT Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform OTHER TESTS ABO blood group RhD blood group HLA Genetic, please specify condition Culture In certain circumstances depending on the donor`s history 6 of 6 2. REPRODUCTIVE T&C 30/06/2016