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 Non-reproductive tissues and cells VIRAL HIV 1 and HIV 2 Hepatitis B Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT YES Ministry of Health; living donors only HBs Ag YES YES Anti-HBc YES YES Anti - HBs HBV NAT YES Ministry of Health; living donors only For living donors if HIV has been tested by NAT no further is mandatory Additional if Anti-HBc is positive and HBsAg is negative. Tests for active replication and/or viral load. Anti-HBs should be > 50 IU/l. For tissues and cells that can be stored for long periods, the test must be repeted after 180 days; for child donors aged up to 3 months, the mother isalso tested adter delivery; tests must be performed in accredited laboratories For tissues and cells that can be stored for long periods, the test must be repeted after 180 days; for child donors aged up to 3 months, the mother isalso tested adter delivery; tests must be performed in accredited laboratories Hepatitis C Anti-HCV YES N/A HCV NAT YES Ministry of Health; living donors only For tissues and cells that can be stored for long periods, the test must be repeted after 180 days; for child donors aged up to 3 months, the mother isalso tested adter delivery; tests must be performed in accredited laboratories HTLV-1 Technique not specified Anti-HTLV-1 YES N/A donors/partners/ parents originating/have been living/coming from high risk area HTLV-1 NAT 1 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
2 HTLV-2 Chikungunya virus Cytomegalovirus Technique not specified Dengue Virus Anti-CMV YES N/A In immuno-suppressed donors CMV NAT Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Technique not specified YES N/A Testing is mandatory for donors with travel history in a highrisk country or highrisk of acquiring the disease. No local malaria. Some local short outbursts from imported malaria. 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 Toxoplasmosis Trypanosomiasis BACTERIAL Treponema pidum (Syphilis) Technique not specified YES N/A partner and nonpartner Anti-T. pidum YES N/A mandatory VDRL T. pidum NAT YES Ministry of Health; recommended YES TPPA assay mandatory if VDRL proves positive If the non-specific antibody test is positive - specific tests are mandatory (e.g. NAT or TPPA assay) Chlamydia trachomatis Technique not specified YES N/A Mandatory only if donor history reveals elevated risk of the infectious agent Neisseria gonorrhoeae Brucellosis Tuberculosis C. trachomatis DFA C. trachomatis EIA C. trachomatis NAT Culture 3 of 7 1.N-REPRODUCTIVE T&C 30/06/2016
4 Q-fever FUNGI Transmissible spongiform encephalopathies Other Tests ABO blood group RhD blood group HLA ABO typing YES N/A RhD typing YES N/A Technique not specified HLA Ab YES YES Bulgarian Association of Clinical Immunology HLA Ag YES YES Bulgarian Association of Clinical Immunology HLA gene YES YES Bulgarian Association of Clinical Immunology see further comments see further comments see further comments Immunological preparation for ogeneic bone marrow transplantation and peripheral hematopoietic stem cells and stem cells from umbilical cord is performed according to Ordinance 43 of 26 August 2010 establishing medical standards "immunological preparation for organ, tissue and cell transplantation" Genetic, please specify condition inherited diseases 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 Reproductive tissues and cells VIRAL HIV 1 and HIV 2 Hepatitis B Hepatitis C HTLV-1 Anti-HIV 1 YES N/A Anti-HIV 2 YES N/A HIV 1p24 HIV NAT YES Ministry of Health; only for non partner donors Sperm donors can skip after-180-days if tested by NAT HBs Ag YES N/A Anti-HBc YES N/A Anti - HBs HBV NAT YES Ministry of Health; only for non partner donors Sperm donors can skip after-180-days if tested by NAT Anti-HCV YES N/A HCV NAT YES YES Ministry of Health; only for non partner Sperm donors can skip donors after-180-days if tested by NAT Anti-HTLV-1 YES N/A Testing for antibodies to HTLV-I is performed for donors who were born or lived in areas with high risk or have sexual partners originating from those regions, as well as the donor's parents are from such regions. Oocyte donors are tested at recruitment and at the day of donation (NAT recommended) and results should be available before transfer of embryos. Sperm is usuy qurantined for 180 days and donors retested after this period; tests must be performed only in accredited laboratories. Oocyte donors are tested at recruitment and at the day of donation (NAT recommended) and results should be available before transfer of embryos. Sperm donors are usuy qurantined for 180 days and retested; tests only in accredited laboratories. Oocyte donors are tested at recruitment and at the day of donation (NAT recommended) and results should be available before transfer of embryos. Sperm donors are usuy qurantined for 180 days and retested. HTLV-2 Chikungunya virus HTLV-1 NAT No cases yet in Bulgaria, but since 2011 Aedes 5 of 7 2.REPRODUCTIVE T&C 30/06/2016
6 Cytomegalovirus Technique not specified albopictus is found in Bulgaria (mostly eastern parts near tha Black sea) Anti-CMV YES N/A Testing required in high risk donors (if health history discloses such risk). CMV NAT Dengue Virus Ebola Virus Epstein-Barr virus Hepatitis E Human Parvovirus B19 Herpes simplex virus West Nile Virus PARASITIC Babesiosis Leishmaniasis Malaria Technique not specified YES N/A For donors with a history of travel in a high risk country or the presence of a high risk for the disease. No local malaria. Some local short outbursts from imported malaria. Toxoplasmosis Trypanosomiasis Plasmodium sp. Ab Plasmodium sp. Ag Plasmodium sp. Ag - rapid test Plasmodium sp. NAT Technique not specified YES N/A For donors with a history of travel in a high risk country or the presence of a high risk for the disease. IgG before pregnancy is recommended by TEs as for rubella. IgG positive are considered immune. Moderate (24.11% - for 2011) prevalence of seropositive people in the Anti-Trypanosoma cruzi 6 of 7 2.REPRODUCTIVE T&C 30/06/2016
7 BACTERIAL Brucellosis Tuberculosis Q-fever N. gonorrhoeae NAT Culture YES N/A Candida spp. Culture YES N/A Transmissible spongiform Other Tests AB0 blood group HLA Genetic, please specify condition specify technique Treponema pidum Technique not specified YES N/A partner and nonpartner If the non-specific antibody test is positive - (Syphilis) specific tests are mandatory (e.g. NAT or TPPA Anti-T. pidum YES N/A mandatory VDRL assay) T. pidum NAT YES Ministry of Health; recommended YES TPPA assay mandatory if VDRL proves positive Chlamydia trachomatis Technique not specified EIA still available, but high prevalence of seropositive people. NAT perfromed from urine C. trachomatis DFA C. trachomatis EIA in males and from cervical smear in females. C. trachomatis NAT YES N/A partner and nonpartner Neisseria gonorrhoeae Culture Technique not specified YES N/A Both culture and NAT are owed. FUNGI RhD blood group Prion (PrP) detection AB0 typing YES N/A RhD typing YES N/A Technique not specified YES N/A Karyotyping, for monogenic disesases etc. Tissue establishments working with non partner donors are karyoryping them as a rule; mandatory by law to test non partner donors if coming from a region or group with high prevalence or with family history of certain genetic diseases (e.g. muscle dystrophia, cystic fibrosis, beta-thalassaemia etc.) 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 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 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 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 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
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
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