Non-reproductive tissues and cells
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1 Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding on national level More stringent - recommended on national level Not legy binding and not recommended on national level Tested pathogen VIRAL HIV 1 and HIV 2 Hepatitis B Hepatitis C HTLV-1 Donor test/ technique Legy binding Non-reproductive tissues and cells Recommended on national level Recommending authority/ association Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT HBs Ag YES N/A Anti-HBc YES N/A Anti - HBs HBV NAT Anti-HCV YES N/A HCV NAT Technique not specified Anti-HTLV-1 YES N/A 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 Circumstances for application Donor profile Tissue/cell type Comments NAT can be done, but not compulsory. NAT can be done, but not compulsory. NAT can be done, but not compulsory. HTLV-2 Chikungunya virus HTLV-1 NAT 1 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
2 Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application Cytomegalovirus Technique not specified YES N/A Testing is mandatory for living donors Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Anti-CMV CMV NAT Technique not specified YES N/A Testing is mandatory for living donors Anti-EBV Technique not specified YES N/A Testing is mandatory for living donors Plasmodium sp. Ab Plasmodium sp. Ag Plasmodium sp. Ag - rapid test Plasmodium sp. NAT 2 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
3 Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application Toxoplasmosis Technique not specified YES N/A Testing is mandatory for living donors Anti-Toxoplasma gondii Trypanosomiasis Technique not specified YES N/A Testing is mandatory for living donors Anti-Trypanosoma cruzi BACTERIAL Treponema pidum Technique not specified YES N/A (Syphilis) Anti-T. pidum T. pidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Q-fever FUNGI Transmissible spongiform Other Tests ABO blood group 3 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
4 Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application RhD blood group HLA Genetic, please specify condition RhD typing YES N/A Testing is mandatory for living donors Technique not specified YES N/A Testing is mandatory for living donors HLA Ab HLA Ag HLA gene 4 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
5 Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legy binding on national level More stringent - recommended on national level Not legy binding and not recommended on national level Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application VIRAL HIV 1 and HIV 2 Hepatitis B Hepatitis C HTLV-1 Reproductive tissues and cells Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT HBs Ag YES N/A Anti-HBc YES N/A Anti - HBs HBV NAT Anti-HCV YES N/A HCV NAT Technique not specified Anti-HTLV-1 YES N/A 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 HTLV-2 Chikungunya virus Cytomegalovirus Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E HTLV-1 NAT Technique not specified YES N/A Anti-CMV CMV NAT 5 of 7 2.REPRODUCTIVE T&C 30/06/2016
6 Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application Human Parvovirus B19 Herpes simplex virus West Nile Virus Herpes genitalis PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum (Syphilis) Chlamydia trachomatis Technique not specified YES N/A specify technique Technique not specified YES N/A non-partner donors Anti-T. pidum T. pidum NAT Technique not specified YES N/A Neisseria gonorrhoeae C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES N/A sperm donors sperm except partners Culture Technique not specified YES N/A Brucellosis Tuberculosis Q-fever Trichomonas vaginalis FUNGI Transmissible spongiform encephalopathies Other Tests N. gonorrhoeae NAT Culture Technique not specified YES N/A specify technique 6 of 7 2.REPRODUCTIVE T&C 30/06/2016
7 Tested pathogen Donor test/ technique Legy binding Recommended Recommending Circumstances for application ABO blood group RhD blood group Genetic, please specify condition Specify technique YES N/A non-partner donors Genetic is legy binding as national requirement, but the law does not specify technique 7 of 7 2.REPRODUCTIVE T&C 30/06/2016
Non-reproductive tissues and cells
Colour key Tested pathogen VIRAL Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legy binding on national level More stringent testing - recommended on national level Not
Non-reproductive tissues and cells Recommending authority/ association
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 Tested pathogen Donor test/ technique
Non-reproductive tissues and cells
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
Non-reproductive tissues and cells Recommending authority/ association
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
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding
Non-reproductive tissues and cells Recommending authority/ association
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent - legally binding More stringent - recommended Not legally binding and not recommended Non-reproductive tissues and cells
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC More stringent testing - legally binding on national level More stringent testing - recommended on national level Not legally binding
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles
Non-reproductive tissues and cells Recommending authority/ association
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 Non-reproductive tissues and cells VIRAL
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