Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recomd on national level Not legy binding and not recomd on national level Tested pathogen Donor test/ technique Legy binding Recom VIRAL HIV 1 and HIV 2 Hepatitis B Anti-HIV 1 YES YES Spanish Tissue Banks Anti-HIV 2 YES YES Spanish Tissue Banks HIV 1p24 YES Spanish Tissue Banks HIV NAT YES Spanish Tissue Banks Ag HIV HBs Ag YES YES Spanish Tissue Banks Anti-HBc YES YES Spanish Tissue Banks Anti - HBs Non-reproductive tissues and cells living donors optional testing to avoid retesting after 180 days in case of long term storage optional testing, in particular performed when HBs Ag negative and Anti HBc positive HBV NAT YES Spanish Tissue Banks optional testing, in particular performed when HBs Ag negative and Anti HBc positive Hepatitis C Anti-HCV YES YES Spanish Tissue Banks HCV NAT YES YES Spanish Tissue Banks only for HPC HTLV-1 Technique not specified 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 1 of 7 1. N-REPRODUCTIVE T&C 30/06/2016
Tested pathogen Donor test/ technique Legy binding Recom HTLV-1 NAT YES Spanish Tissue Banks living donors testing is performed to avoid repeat sampling and additional testing after 180 days when tissues and cells can be stored for long time periods HTLV-2 Technique not specified Anti-HTLV-2 YES N/A donors living in or originating from a high prevalence area, or parents or sexual partners originating from those areas HTLV-2 NAT YES Spanish Tissue Banks recomd for donors living donors testing is performed to avoid repeat sampling and additional testing after 180 days when tissues and cells can be stored for long time periods Chikungunya virus Cytomegalovirus Dengue virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus optional testing depending on clinical history or epidemiologic risk of the disease 2 of 7 1. N-REPRODUCTIVE T&C 30/06/2016
Tested pathogen Donor test/ technique Legy binding Recom West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum (Syphilis) Technique not specified YES N/A Anti-T. pidum YES YES Spanish Tissue Banks Microscopy T. pidum NAT YES YES Spanish Tissue Banks testing is performed when the non-specific test is positive Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis 3 of 7 1. N-REPRODUCTIVE T&C 30/06/2016
Tested pathogen Donor test/ technique Legy binding Recom Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group testing RhD blood group testing HLA testing Genetic testing, please specify 4 of 7 1. N-REPRODUCTIVE T&C 30/06/2016
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recomd on national level Not legy binding and not recomd on national level Tested pathogen VIRAL HIV 1 and HIV 2 Donor test/ technique Legy binding Recomd on national level Anti-HIV 1 YES YES Real Decreto-ley 9/2014, and professional s (SEF-Spanish Fertility Society and ASEBIR-Spanish embryologist recommendations. Links: 1. https://www.boe.es/boe /dias/2014/07/05/pdfs/b OE-A-2014-7065.pdf 2. http://www.sefertilidad. net/docs/biblioteca/libro s/recomendaciones.pdf Reproductive tissues and cells Recommending authority/ Semen: donors must have a negative Ag HBs days. Egg donor : donor must have a negative have HIV NAT before every donation. Anti-HIV 2 YES YES Semen: donors must have a negative Ag HBs days. Egg donor : donor must have a negative have HIV NAT before every donation. Hepatitis B HIV 1p24 HIV NAT YES YES Non-partner donation of sperm Sperm HIV NAT testing ows for release of sperm without repeat testing after 180 days after donation Ag HIV HBs Ag YES YES Semen: donors must have a negative Ag HBs days. Egg donor : donor must have a negative have HBV NAT before every donation. 5 of 7 2.REPRODUCTIVE T&C 30/06/2016
Tested pathogen Donor test/ technique Legy binding Recomd on national level Recommending authority/ Anti-HBc YES YES Semen: donors must have a negative Ag HBs days. Egg donor : donor must have a negative have HBV NAT before every donation. Hepatitis C Anti - HBs HBV NAT YES YES Sperm Testing is performed when the donation is not in quarantine Anti-HCV YES N/A Semen: donors must have a negative Ag HBs days. Egg donor : donor must have a negative have HCV NAT before every donation. HTLV-1 HCV NAT YES N/A Sperm Testing is performed when the donation is not in quarantine Technique not specified Anti-HTLV-1 YES YES Donors living in or originating from areas of high prevalence of HTLV-1 HTLV-2 HTLV-1 NAT Technique not specified Anti-HTLV-2 YES YES Donors living in or originating from areas of high prevalence of HTLV-2 HTLV-2 NAT YES N/A Donors living in or originating from areas of high prevalence Chikungunya virus Cytomegalovirus Dengue Virus Ebola Virus Epstein-Barr virus Additional tests (malaria, toxoplasma, Tripanosoma cruzi, dengue, CMV, VEB, RhD) could be requiered in specific circumstances: 6 of 7 2.REPRODUCTIVE T&C 30/06/2016
Tested pathogen Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus Rubella PARASITIC Babesiosis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum (Syphilis) Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group testing RhD blood group testing HLA testing Genetic testing, please specify Donor test/ technique Legy binding Recomd on national level Recommending authority/ Technique not specified YES YES According to EU Directive tissues and cells Anti-T. pidum Microscopy T. pidum NAT Technique not specified C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES YES Sperm donors Sperm Testing is performed with an urine sample Culture ABO typing YES YES RhD typing YES YES Specify technique YES YES physician criteria: karyotype (always), cystic fibrosis, etc. 7 of 7 2.REPRODUCTIVE T&C 30/06/2016