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 and not recommended on national level VIRAL HIV 1 and HIV 2 Hepatitis B Anti-HIV 1 YES N/A all all Anti-HIV 2 YES N/A all all HIV 1p24 HIV NAT YES N/A all all no comments HBs Ag YES N/A all all Anti-HBc YES N/A all all Anti - HBs YES There is national Non-reproductive tissues and cells all Hematopoietic Progenitor Cells. Only when Anti-HBc is reactive. Hepatitis C HTLV-1 HBV NAT YES N/A all all no comments Anti-HCV YES N/A all all HCV NAT YES N/A all all no comments Anti-HTLV-1 YES N/A Donors living in, or originating from, highincidence areas or with sexual partners originating from those areas or where the donor s parents originate from those areas all 1 of 8 1.N-REPRODUCTIVE T&C 30/06/2016
HTLV-1 NAT YES There is national all Hematopoietic Progenitor Cells no comments HTLV-2 Anti-HTLV-2 YES N/A Donors living in, or originating from, highincidence areas or with sexual partners originating from those areas or where the donor s parents originate from those areas. all HTLV-2 NAT YES There is national all Hematopoietic Progenitor Cells. no comments no comments Chikungunya virus Cytomegalovirus YES N/A all all no comments 2 of 8 1.N-REPRODUCTIVE T&C 30/06/2016
Anti-CMV YES There is national all all CMV positive tissues are not recommended for application into immunodeficient patients, however, in urgent cases, and when in shortage for some type of tissues (for instances when skin is needed in cases of severe burns), this criterion is not applied. CMV NAT Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E H1N1 YES IPST: http://www.ipst.pt/sit eipst/files/circular_nor mativa_n_17gdg.pdf In certain Leishmaniasis Toxoplasmosis circumstances of outbreaks, when there is suspicion of a possible infection, and only if donation is urgent. YES N/A In certain circumstances that migth require additional testing depending on the donor s history. Anti-Toxoplasma gondii Hematopoietic Progenitor Cells. Depending on the characteristics of the tissue or cells donated. no comments Usually, donors with risk for Toxoplasmosis are not considered Trypanosomiasis YES N/A In certain circumstances that migth require additional testing depending on the donor s history. Depending on the characteristics of the tissue or cells donated. Usually, donors with risk for Trypanosomiasis are not considered 3 of 8 1.N-REPRODUCTIVE T&C 30/06/2016
Anti-Trypanosoma cruzi BACTERIAL Treponema pallidum YES N/A all all (Syphilis) Anti-T. pallidum T. pallidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group testing ABO typing YES There is national all all no comments RhD blood group testing RhD typing YES YES There is national all all no comments 4 of 8 1.N-REPRODUCTIVE T&C 30/06/2016
HLA testing HLA Ab HLA Ag HLA gene YES There is national all all HLA typing is carried out whenever appropriate determine compatibility; for PH, SCU, corneal tissues Genetic testing, please specify condition 5 of 8 1.N-REPRODUCTIVE T&C 30/06/2016
CNPMA - National Council for Medically Assisted Procreation) 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 and not recommended on national level Tested pathogen Donor test/ technique Legally binding Recommended on national level VIRAL HIV 1 and HIV 2 Chikungunya virus Cytomegalovirus Dengue Virus 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 Anti-HTLV-1 YES N/A HTLV-1 NAT Anti-HTLV-2 YES N/A HTLV-2 NAT YES Anti-CMV CMV NAT Reproductive tissues and cells Recommending authority/ association N/A Circumstances for application Donor profile Tissue/cell type Comments Testing for HIV 1 and 2 is mandatory for partner and non partner donation. In case of partner donation with a positive result for HIV it is required a system Testing for HBV is mandatory for partner and non partner donation. In case of partner donation with a positive result for HBV it is required a system In the case of partner donation not for direct use, the clinician responsible for the donor HTLV-I antibody testing must be performed for donors living in or coming from high-incidence areas or with sexual partners HTLV-II antibody testing must be performed for donors living in or coming from high-incidence areas or with sexual partners In certain circumstances that migth require additional testing depending on the donor s history, and the All All NAT is not mandatory for HIV but it requires a second test on samples collected after quarantine period. If the sample is additionally tested for HIV For non-partner donation blood samples must be obtained in the 3 months prior to donation. Nonpartner sperm donations must be quarantined for a minimum of 180 For non-partner donation blood samples must be obtained in the 3 months prior to donation. Nonpartner sperm donations must be quarantined for a minimum of 180 For non-partner donation blood samples must be obtained at the Hepatitis B All reproductive T&C NAT is not mandatory for HCV but it requires a second test on samples collected after quarantine period. If the sample is additionally tested for HCV Hepatitis C NAT is not mandatory for HCV but it requires a second test on samples time of donation. Non-partner collected after quarantine HTLV-1 All Recomendation of the National Competent Authority to consider the ECDC HTLV prevalence map. HTLV-2 All Recomendation of the National Competent Authority to consider the ECDC HTLV prevalence map. Whenever there is an outbreak with Whenever there is an outbreak with relevance to reproductive T&C donation, there is a national notice defining additional measures or deferral. Ebola Virus Epstein-Barr virus Whenever there is an outbreak with relevance to reproductive T&C donation, there is a national notice defining additional measures or deferral. There are no binding obligations, but centres can define more stingent testing requirements. 6 of 8 2.REPRODUCTIVE T&C 30/06/2016
CNPMA - National Council for Medically Assisted Procreation) Tested pathogen Donor test/ technique Legally binding Recommended on national level Hepatitis E Recommending authority/ association Circumstances for application Donor profile Tissue/cell type Comments There are no binding obligations, but centres can define more stingent testing requirements for non-partner donation. Human Parvovirus B19 Herpes simplex virus Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis YES Plasmodium sp. Ab Plasmodium sp. Ag Plasmodium sp. Ag - rapid test Plasmodium sp. NAT YES N/A Testing applies for all donations and donor profiles (partner and nonpartner donation). Anti-Trypanosoma cruzi N/A In certain circumstances All additional testing is required depending on the donor s history, and the characteristics of the tissue or cells donated. This reference applies to partner and non-partner donation. All There are no binding obligations, but centres can define more stingent testing requirements. There are no binding obligations, but centres can define more stingent testing requirements. BACTERIAL Treponema pallidum (Syphilis) Chlamydia trachomatis YES N/A This reference aplies to partner and non-partner donation. Anti-T. pallidum T. pallidum NAT All The Nationa Law requires testing for non-partner donation. The National ART CA add the obligation to screen also for partner donation. Neisseria gonorrhoeae Brucellosis Tuberculosis C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES N/A For non-partner donation Culture Sperm 7 of 8 2.REPRODUCTIVE T&C 30/06/2016
CNPMA - National Council for Medically Assisted Procreation) Tested pathogen Donor test/ technique Legally binding Recommended on national level Q-fever FUNGI Transmissible spongiform Other Tests ABO blood group testing RhD blood group testing Recommending authority/ association Circumstances for application Donor profile Tissue/cell type Comments ABO typing YES National ART CA For non-partner All donation RhD typing YES N/A In certain circumstances that migth require additional testing depending on the donor s history, and the characteristics of the tissue or cells donated. This reference aplies to partner and non-partner donation. All Whenever there is an outbreak with relevance to reproductive T&C donation, there is a national notice defining additional HLA testing Genetic testing, please specify condition YES N/A For partner donation Embryos HLA Ab HLA Ag HLA gene Specify technique YES N/A For non-partner donation When there is a forceful need to obtain compatible HLA group for the purposes of treating a serious illness. Must be authorised by the National CA. All Genetic screening for autosomal recessive genes known to be prevalent, according to international scientific evidence, in the donor s ethnic background and an assessment of the risk of transmission of inherited conditions known to be present in the family must be carried out. 8 of 8 2.REPRODUCTIVE T&C 30/06/2016