Non-reproductive tissues and cells Recommending authority/ association
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1 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 Circumstances for application Regional differences Further comments VIRAL HIV 1 and HIV 2 Hepatitis B Hepatitis C HTLV-1 Anti-HIV 1 YES N/A all all Anti-HIV 2 YES N/A all all HIV 1p24 HIV 1p24 is offered at several laboratories and automatically included in the donor screening HIV NAT YES Danish Patient Safety deceased all no comments HBs Ag YES N/A all all Anti-HBc YES N/A all all Anti - HBs HBV NAT YES Danish Patient Safety deceased all no comments Anti-HCV YES N/A all all HCV NAT YES Danish Patient Safety deceased all no comments Technique not specified Anti-HTLV-1 YES N/A must be performed for donors originating from highprevalence areas or with parents or sexual partners originating from those areas all If the donor or his /hers sexual partner or parents originates from an area with high prevalence it is mandatory 1 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
2 Circumstances for application Regional differences Further comments HTLV-2 Chikungunya virus Cytomegalovirus Dengue Virus HTLV-1 NAT Technique not specified YES Danish Patient Safety donor and actual Ebola Virus Technique not specified YES Danish Patient Safety donor and the actual risk in a country Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus Technique not specified YES Danish Patient Safety WNV minipool NAT WNV ID NAT Zika Virus Technique not specified YES Danish Patient Safety PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pallidum (Syphilis) Technique not specified YES N/A all all donor and the seasonal risk donor and actual 2 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
3 Circumstances for application Regional differences Further comments Anti-T. pallidum Microscopy T. pallidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group HLA ABO typing YES Danish Haematological allogeneic HSC no comments Society/ y.dk RhD typing YES Danish Haematological Society/ y.dk allogeneic HSC And recommended by some ortopedic centres for bone donors Technique not specified YES Danish Haematological allogeneic HSC no comments Society/ y.dk Genetic, please specify condition HLA Ab HLA Ag HLA gene 3 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
4 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 Reproductive tissues and cells VIRAL HIV 1 and HIV 2 Anti-HIV 1 YES N/A all gametes non-partner sperm donor should be quarantined for 180 days and then Anti-HIV 2 YES N/A all gametes non-partner sperm donor should be quarantined for 180 days and then HIV 1p24 HIV 1p24 is offered on a routine basis at most laboratories and automatically included in the donor screening Testing requirements for eggdonors are the same as for nonpartner sperm donors, i.e serological and NAT are mandatory, since it is not possible to test eggdonors 180 days after donation. Blood samples can be taken up to 30 days before donation. NAT for HIV, HBV and HCV is mandatory for egg donors. HIV NAT YES YES Danish Patient Safety all gametes egg donor mandatory; non-partner sperm donor instead of re after 180 days Hepatitis B HBs Ag YES N/A all gametes non-partner donations should be quarantined for 180 days and then 4 of 7 2.REPRODUCTIVE T&C 30/06/2016
5 Anti-HBc YES N/A all gametes non-partner donations should be quarantined for 180 days and then Anti - HBs HBV NAT YES YES Danish Patient Safety all gametes egg donor mandatory; non-partner sperm donor instead of re after 180 days Hepatitis C Anti-HCV YES N/A all gametes non-partner donations should be quarantined for 180 days and then HCV NAT YES YES Danish Patient Safety all gametes egg donor mandatory; non-partner sperm donor instead of re after 180 days HTLV-1 Technique not specified Anti-HTLV-1 YES N/A must be performed for donors originating from highprevalence areas or with parents or sexual partners originating from those areas gametes HTLV-2 Chikungunya virus Cytomegalovirus Dengue Virus HTLV-1 NAT Technique not specified YES Danish Patient Safety all gametes depending on the donor and the 5 of 7 2.REPRODUCTIVE T&C 30/06/2016
6 Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus Anti-DENV NAT Technique not specified YES Danish Patient Safety Anti-EBV Technique not specified YES Danish Patient Safety WNV minipool NAT WNV ID NAT Zika Virus Technique not specified YES Danish Patient Safety PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pallidum (Syphilis) Chlamydia trachomatis Technique not specified YES N/A non-partner donor gametes Anti-T. pallidum Microscopy T. pallidum NAT Technique not specified C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES N/A non-partner donor sperm Culture all gametes depending on the donor and the actual risk in a country all gametes depending on the donor and the seasonal risks donor and actual 6 of 7 2.REPRODUCTIVE T&C 30/06/2016
7 Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group HLA Genetic, please specify condition Technique not specified YES YES Danish Patient Safety N. gonorrhoeae NAT Culture non-partner donor sperm no comments Specify technique YES N/A non-partner donor sperm screened for autosomal recessive genes known to be prevalent in the donor's ethnic background 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
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
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
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 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 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
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 - legy binding More stringent - recommended Not legy binding and not recommended Non-reproductive tissues and cells VIRAL
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