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 Non-reproductive tissues and cells VIRAL HIV 1 and HIV 2 Hepatitis B Hepatitis C HTLV-1 HTLV-2 Anti-HIV 1 YES N/A all all Anti-HIV 2 YES N/A all all HIV 1p24 HIV NAT YES N/A living donor HPCs; for living donor of tissues if serology is not days HBs Ag YES N/A all all Anti-HBc YES N/A all all Anti - HBs HBV NAT YES N/A living donor HPCs; for living tissue donor if serology is not days ; all tissues from living donors ; all tissues from living donors Anti-HCV YES N/A all all HCV NAT YES N/A living donor HPCs; for living tissue donor if serology is not days ; all tissues from living donors Anti-HTLV-1 YES N/A HTLV - 1 testing is all carried out only on donors with identified risk HTLV-1 NAT Anti-HTLV-2 YES N/A HTLV - 2 testing is all carried out only on donors with identified risk In some regions (e.g. Toscana and Veneto) the NAT test in living donors of tissues is always performed even if serology has been days. In some regions Anti - HBs maybe performed if anti (e.g.toscana and - HBc results are positive Veneto) the NAT test in living donors of tissues is always performed even if serology has been repeated after 180 days. In some regions (e.g. Toscana and Veneto) the NAT test in living donors of tissues is always performed even if serology has been 1 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Chikungunya virus HTLV-2 NAT YES N/A all all All donors that have been in risky Cytomegalovirus Anti-CHIKV CHIKV NAT Anti-CMV YES YES IBMDR Standard - http://ibmdr.galliera.it living and cadaveric donors areas 28 days before or are syntomatic are excluded without further testing. The testing is /english-version/ibmdrmanual-of-operation for HPCs. For tissues: Italian guideline on quality and safety of tissues - july 2013. HPCs, skin, cardiac valves, vessels, amniotic membrane According to the National guidelines on tissues (https://www.trapianti.salute.gov.i t/imgs/c_17_normativa_27_allega to.pdf) the NAT test has to be performed if anti -CMV IgM results are positive. CMV NAT Dengue Virus Anti-DENV YES N/A all all NAT Ebola Virus NAT YES N/A all all Anti-EBV YES N/A all all Hepatitis E Human Parvovirus B19 Herpes simplex virus Epstein-Barr virus According to the Ministerial Decree West Nile Virus PARASITIC WNV minipool NAT WNV ID NAT YES N/A testing is carried out only on donors with identified risk HPCs and bone only if frozen Babesiosis Leishmaniasis Malaria According to the Ministerial Decree Plasmodium sp. Ab YES N/A testing is carried out only on donors with identified risk all o+legislativo+16+2010) malaria testing has to be performed All donors that have been in risky areas or are symptomatic are excluded. All the other donors must be tested. All donors that have been in risky areas or are symptomatic are excluded. All the other donors 2 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Plasmodium sp. Ag Plasmodium sp. Ag - rapid test Plasmodium sp. NAT IgM on amniotic membrane donors Anti-Toxoplasma gondii YES YES IBMDR Standard - http://ibmdr.galliera.it /english-version/ibmdrmanual-of-operation for HPCs. all donors all BACTERIAL Blood cultures YES Jacie Standard - https://docs.google.com/vie wer?a=v&pid=sites&srcid=am FjaWUub3JnfGphY2llfGd4OjM 2Mzc5YzZmYTk0YmYzNzY depending on the donor's history and the characteristics of the tissues Toxoplasmosis According to the Ministerial Decree o+legislativo+16+2010) and the national guidelines on tissues (https://www.trapianti.salute.gov.i t/imgs/c_17_normativa_27_allega to.pdf) toxoplasmosis testing has Trypanosomiasis to be performed on all amniotic membrane donors and for the According to the Ministerial Decree Anti-Trypanosoma cruzi YES N/A testing is carried out all only in donors with identified risk o+legislativo+16+2010) Trypanosoma testing has to be performed depending on the Treponema pallidum YES N/A all all (Syphilis) Anti-T. pallidum YES N/A all donors all T. pallidum NAT Chlamydia trachomatis Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI specify technique YES Jacie Standard - https://docs.google.co m/viewer?a=v&pid=sit es&srcid=amfjawuub3 JnfGphY2llfGd4OjM2M zc5yzzmytk0ymyznzy 3 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
Transmissible spongiform encephalopathies Other Tests ABO blood group testing ABO typing YES National laws: legge 219/2005 and DM 3.3.2005 (http://www.centronaz ionalesangue.it/pagine /normativa-000) For HPCs: donors that have performed surgery or transfusion between 1980 to 1996 in UK are excluded For the other tissues it's not required RhD blood group testing RhD typing YES National laws: legge 219/2005 and DM 3.3.2005 (http://www.centronaz ionalesangue.it/pagine /normativa-000) For the other tissues it's not required HLA testing For the other tissues it's not required HLA Ab HLA Ag HLA gene YES YES National laws: legge 219/2005 and DM 3.3.2005 (http://www.centronaz ionalesangue.it/pagine /normativa-000) Genetic testing, please specify condition The type of techniques depends from what kind of infection/disease you suspect or you are looking for. The techniques are detailed in the IBMDR Standards YES YES IBMDR Standard - http://ibmdr.galliera.it /english-version/ibmdrmanual-of-operation for HPCs. HPCs Cord Blood and PBSC In case of relevant medical testing or anamnestic history of hemoglobinopaties or of coagulation defects 4 of 6 1.N-REPRODUCTIVE T&C 30/06/2016
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 Hepatitis B Hepatitis C HTLV-1 Reproductive tissues and cells Recommending authority/ association Circumstances for application Donor profile Tissue/cell type Comments Anti-HIV 1 YES N/A partner donor gametes Anti-HIV 2 YES N/A partner donor gametes HIV 1p24 HIV NAT HBs Ag YES N/A partner donor gametes Anti-HBc YES N/A partner donor gametes Anti - HBs HBV NAT Anti-HCV YES N/A partner donor gametes HCV NAT YES N/A partner donor gametes Anti-HTLV-1 YES N/A Anti-HTLV 1 is mandatory for donors living in or coming from areas with high prevalence of HTLV or whose sexual partners or parents live or originate from areas with high prevalence of HTLV-1 all General note: all the information that is given for reproductive T&C refers exclusively to partner donation. Italy has introduced only recently the heterologous donation HTLV-2 Chikungunya virus Cytomegalovirus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus HTLV-1 NAT YES N/A partner donor gametes Anti-HTLV-2 HTLV-2 NAT 5 of 6 2.REPRODUCTIVE T&C 30/06/2016
Tested pathogen Donor test/ technique Legally binding Recommended on national level West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pallidum (Syphilis) Chlamydia trachomatis Recommending authority/ association YES N/A non-partner donors all Circumstances for application Donor profile Tissue/cell type Comments Anti-T. pallidum T. pallidum NAT YES N/A partner donors all bacteriology testing of tissues/cells is a requirement for all types of donations Neisseria gonorrhoeae Brucellosis Tuberculosis Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group HLA testing Genetic testing, please specify condition C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT YES N/A all sperm donors except partners Culture sperm mandatory for all sperm donors except partners 6 of 6 2.REPRODUCTIVE T&C 30/06/2016