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 - legy binding More stringent - recommended Not legy binding and not recommended Tested pathogen Donor test/ technique Legy binding Recommended VIRAL HIV 1 and HIV 2 Non-reproductive tissues and cells Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT YES N/A deceased, living (only ogeneic donors) All deceased donors need to be tested by serological test AND viral NAT-tests (HIV, HBV, HCV). All living donors (ogenic grafts) need to be tested by serological tests AND viral NAT-tests (no quarantine) or 180-day-test (quarantine). Living donors (autologous grafts) need to be tested by serological tests. Hepatitis B Ag HIV HBs Ag YES N/A Anti-HBc YES N/A Anti - HBs HBV NAT YES N/A deceased, living (only ogeneic donors) All deceased donors need to be tested by serological test AND viral NAT-tests (HIV, HBV, HCV). All living donors (ogenic grafts) need to be tested by serological tests AND viral NAT-tests (no quarantine) or 180-day-test (quarantine). Living donors (autologic grafts) need to be tested by serological tests. Hepatitis C Anti-HCV YES N/A HCV NAT YES N/A deceased, living (only ogeneic donors) All deceased donors need to be tested by serological test AND viral NAT-tests (HIV, HBV, HCV). All living donors (ogenic grafts) need to be tested by serological tests AND viral NAT-tests (no quarantine) or 180-day-test (quarantine). Living donors (autologic grafts) need to be tested by serological tests. 1 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
2 Tested pathogen Donor test/ technique Legy binding Recommended HTLV-1 Technique not specified YES N/A risk groups 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 HTLV-1 NAT Technique not specified YES N/A risk groups Anti-HTLV-1 HTLV-2 NAT Technique not specified YES N/A risk groups Anti-CMV CMV NAT Technique not specified YES N/A risk groups Anti-EBV Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Technique not specified YES N/A risk groups Plasmodium sp. Ab Plasmodium sp. Ag Plasmodium sp. Ag - rapid test Plasmodium sp. NAT Technique not specified YES N/A risk groups Anti-Toxoplasma gondii 2 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
3 Tested pathogen Donor test/ technique Legy binding Recommended Trypanosomiasis Technique not specified YES N/A risk groups Anti-Trypanosoma cruzi BACTERIAL Treponema pidum (Syphilis) Technique not specified YES N/A According to the directive: A validated algorithm must be applied to exclude the presence of active infection with Treponema pidum. A non-reactive test, specific or nonspecific, can ow 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. Anti-T. pidum T. pidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group HLA RhD typing YES N/A risk groups Technique not specified YES N/A risk groups 3 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
4 Tested pathogen Donor test/ technique Legy binding Recommended Genetic, please specify condition 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 More stringent - recommended Not legy binding and not recommended Tested pathogen VIRAL HIV 1 and HIV 2 Donor test/ technique Legy binding Recommended Anti-HIV 1 YES N/A except IUI (partner Anti-HIV 2 YES N/A except IUI (partner Reproductive tissues and cells No is required in the case of partner donation of reproductive cells for direct use - IUI. HIV 1p24 HIV NAT YES N/A donor (nonpartner donation) ** All deceased donors need to be tested by serological test AND viral NAT-tests (HIV, HBV, HCV). All living donors (ogenic grafts) need to be tested by serological tests AND viral NAT-tests (no quarantine) or 180-day-test (quarantine). Living donors (autologous grafts) need to be tested by serological tests. Hepatitis B Ag HIV HBs Ag YES N/A except IUI (partner Anti-HBc YES N/A except IUI (partner Hepatitis C Anti - HBs HBV NAT YES N/A donors (nonpartner donation) ** Anti-HCV YES N/A except IUI (partner **) NAT OR 180-day-re- required HTLV-1 HCV NAT YES N/A donor (nonpartner donation) ** Technique not specified N/A risk groups **) NAT OR 180-day-re- required 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 5 of 7 2.REPRODUCTIVE T&C 30/06/2016
6 Tested pathogen HTLV-2 Chikungunya virus Cytomegalovirus Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Donor test/ technique Legy binding Recommended HTLV-1 NAT Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum (Syphilis) Chlamydia trachomatis Technique not specified YES N/A non-partner donors Anti-T. pidum T. pidum NAT Technique not specified Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT N/A donors (nonpartner donation) Culture 6 of 7 2.REPRODUCTIVE T&C 30/06/2016
7 Tested pathogen HLA Genetic, please specify condition Donor test/ technique Legy binding Recommended 7 of 7 2.REPRODUCTIVE T&C 30/06/2016
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
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
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 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 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
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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DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I DS-EIA-ANTI-HIV-UNIF (Ab) I
* Sensitivity HIV DS-EIA-ANTI-HIV-UNIF (Ab) I-153 96 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-150 192 115 24 DS-EIA-ANTI-HIV-UNIF (Ab) I-155 480 115 24 DS-EIA-HIV-AG-SCREEN I-1452 96 115 12 0.025 IU/ml DS-EIA-HIV-AGAB-SCREEN