Testing requirements and deferral or exclusion criteria for allogeneic donations
On 7 August 2027, the provisions of Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO Regulation) becomes applicable. Pursuant to Articles 56(4)(a)(i) and 59 (4)(a)(i) of the SoHO Regulation, ECDC is mandated to publish evidence-based, up-to-date technical guidelines concerning the prevention of communicable disease transmission through donations of SoHO or medically assisted reproduction. In the tables on this webpage, ECDC presents available testing requirements and deferral or exclusion criteria for allogeneic donations.
In the absence of technical guidelines published by ECDC, ECDC refers to the testing requirements and deferral or exclusion criteria in Directive 2002/98/EC, Commission Directive 2004/33/EC, and Commission Directive 2014/110/EU for blood and blood components and plasma for fractionation, and to those in Commission Directive 2006/17/EC and Commission Directive 2012/39/EU for tissues and cells and reproductive cells. Once ECDC technical guidelines are published for a pathogen and SoHO type, the testing requirements and deferral or exclusion criteria for allogeneic donations in those guidelines will apply.
For SoHO not covered by directives or ECDC technical guidelines, i.e. breast milk and faecal microbiota, references to specific third-party sources are provided.
List of tables
Blood and blood components
Table 1. Testing requirements for donors of whole blood and plasma donations
Table 2. Deferral criteria for donors of whole blood and blood components
Table 3. Deferral criteria after exposure for donors of whole blood and blood components
Table 4. Testing requirements for donors of plasma for fractionation
Table 5. Deferral criteria for donors of plasma for fractionation
Table 6. Deferral criteria after exposure for donors of plasma for fractionation
Tissues & cells
Table 7. Testing requirements for living and deceased donors of tissues and cells (except donors of reproductive cells)
Table 8. Exclusion criteria for living and deceased donors of tissues and cells (except donors of reproductive cells)
Table 9. Additional exclusion criteria for deceased child donors of tissues and cells
Reproductive cells
Table 10. Testing requirements for donors of reproductive cells, partner donations and donations other than by partners
Table 11. Exclusion criteria for donations other than by partners of reproductive cells
Table 1. Testing requirements for donors of whole blood and plasma donations
| Infection | Testing requirements as in Directive 2002/98/EC | Testing requirements in technical guidelines by ECDC |
| HIV 1/2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B | HBs-Ag | |
| Hepatitis C | Anti-HCV |
Table 2. Deferral criteria for donors of whole blood and blood components
| Infection | Deferral criteria as in Directive 2004/33/EC | Deferral criteria in technical guidelines by ECDC |
| HIV 1/2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B | Permanent, except for HBsAg-negative persons who are demonstrated to be immune | |
| Hepatitis C | Permanent | |
| HTLV I/II | Permanent | |
| Babesiosis | Permanent | |
| Kala Azar (visceral leishmaniasis) | Permanent | |
| Trypanosomiasis cruzi (Chagas' disease) | Permanent | |
| Transmissible spongiform encephalopathies (TSEs), (e.g. Creutzfeldt Jakob Disease, variant Creutzfeldt Jakob Disease) | Permanent for persons who have a family history which places them at risk of developing a TSE, or persons who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands. | |
| Brucellosis | 2 years following the date of full recovery | |
| Osteomyelitis | 2 years after confirmed cured | |
| Q fever | 2 years following the date of confirmed cured | |
| Syphilis | 1 year following the date of confirmed cured | |
| Toxoplasmosis | 6 months following the date of clinical recovery | |
| Tuberculosis | 2 years following the date of confirmed cured | |
| Rheumatic fever | 2 years following the date of cessation of symptoms, unless evidence of chronic heart disease | |
| Fever > °C | 2 weeks following the date of cessation of symptoms | |
| Flu-like illness | 2 weeks after cessation of symptoms | |
| Malaria | ||
|
3 years following return from last visit to any endemic area, provided person remains symptom free; may be reduced to 4 months if an immunologic or molecular genomic test is negative at each donation |
|
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3 years following cessation of treatment and absence of symptoms. Accept thereafter only if an immunologic or molecular genomic test is negative | |
|
6 months after leaving the endemic area unless an immunologic or molecular genomic test is negative | |
|
3 years following resolution of symptoms; may be reduced to 4 months if an immunologic or molecular test is negative
|
|
| West Nile Virus (WNV) | 28 days after leaving a risk area of locally acquired West Nile Virus unless an individual Nucleic Acid Test (NAT) is negative* |
* As in Commission Directive 2014/110/EU.
Table 3. Deferral criteria after exposure for donors of whole blood and blood components
| Exposure | Deferral criteria as in Directive 2004/33/EC | Deferral criteria in technical guidelines by ECDC |
| Endoscopic examination using flexible instruments | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Mucosal splash with blood or needlestick injury | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Transfusion of blood components | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Tissue or cell transplant of human origin | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Major surgery | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Tattoo or body piercing | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Acupuncture unless performed by a qualified practitioner and with sterile single-use needles | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Persons at risk due to close household contact with persons with hepatitis B | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Vaccination with attenuated viruses or bacteria | 4 weeks | |
| Rabies vaccination | If vaccination is given following exposure defer for one year | |
| Pregnancy | 6 months after delivery or termination | |
| Minor surgery | 1 week | |
| Dental treatment (*) | Until next day |
(*) Tooth extraction, root-filling and similar treatment is considered as minor surgery.
Table 4. Testing requirements for donors of plasma for fractionation
| Infection | Testing requirements as in Directive 2002/98/EC | Testing requirements in technical guidelines by ECDC |
| HIV 1/2 | Anti-HIV 1/2 | |
| Hepatitis B | HBs-Ag | |
| Hepatitis C | Anti-HCV |
Table 5. Deferral criteria for donors of plasma for fractionation
| Infection | Deferral criteria as in Directive 2004/33/EC | Deferral criteria in technical guidelines by ECDC |
| HIV 1/2 | Permanent | |
| Hepatitis B | Permanent, except for HBsAg-negative persons who are demonstrated to be immune | |
| Hepatitis C | Permanent | |
| HTLV I/II | Permanent | |
| Transmissible spongiform encephalopathies (TSEs), (e.g. Creutzfeldt Jakob Disease, variant Creutzfeldt Jakob Disease) | Permanent for persons who have a family history which places them at risk of developing a TSE, or persons who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands. For variant Creutzfeldt Jacob disease, further precautionary measures may be recommended. | |
| Osteomyelitis | 2 years after confirmed cured | |
| Tuberculosis | 2 years following the date of confirmed cured | |
| Rheumatic fever | 2 years following the date of cessation of symptoms, unless evidence of chronic heart disease | |
| Fever > °C | 2 weeks following the date of cessation of symptoms | |
| Flu-like illness | 2 weeks after cessation of symptoms |
Table 6. Deferral criteria after exposure for donors of plasma for fractionation
| Exposure | Deferral criteria as in Directive 2004/33/EC | Deferral criteria in technical guidelines by ECDC |
| Endoscopic examination using flexible instruments | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Mucosal splash with blood or needlestick injury | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Transfusion of blood components | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Tissue or cell transplant of human origin | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Major surgery | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Tattoo or body piercing | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Acupuncture unless performed by a qualified practitioner and with sterile single-use needles | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Persons at risk due to close household contact with persons with hepatitis B | Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative | |
| Vaccination with attenuated viruses or bacteria | 4 weeks | |
| Rabies vaccination | If vaccination is given following exposure defer for one year | |
| Pregnancy | 6 months after delivery or termination | |
| Minor surgery | 1 week | |
| Dental treatment (*) | Until next day |
(*) Tooth extraction, root-filling and similar treatment is considered as minor surgery.
Table 7. Testing requirements for living and deceased donors of tissues and cells (except donors of reproductive cells)
| Infection | Testing requirement as in Commission Directive 2006/17/EC | Technical guidelines by ECDC |
| HIV 1 and 2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B |
HBsAg Anti HBc |
|
| Hepatitis C | Anti-HCV-Ab | |
| Syphilis | Validated testing algorithm must be applied to exclude the presence of active infection with Treponema pallidum | |
| HTLV-I | HTLV-I antibody testing for donors living in, or originating from, high-prevalence (*) areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas |
(*) As in Commission Directive 2012/39/EU.
Table 8. Exclusion criteria for living and deceased donors of tissues and cells (except donors of reproductive cells)
| Infection | Exclusion as in Commission Directive 2006/17/EC | Technical guidelines by ECDC |
| HIV 1 and 2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B (acute or chronic) |
When anti-HBc is positive and HBsAg is negative, further investigations are necessary with a risk assessment to determine eligibility for clinical use. Excluded, except in the case of persons with a proven immune status |
|
| Hepatitis C | Excluded | |
| Syphilis | A non-reactive test, specific or non-specific, can allow 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 | |
| HTLV I/II | Excluded | |
|
Prions - Risk of transmission of diseases caused by prions. This risk applies, for example, to: (a) people diagnosed with Creutzfeldt–Jakob disease, or variant Creutzfeldt-Jacob disease, or having a family history of non-iatrogenic Creutzfeldt-Jakob disease; (b) people with a history of rapid progressive dementia or degenerative neurological disease, including those of unknown origin; (c) recipients of hormones derived from the human pituitary gland (such as growth hormones) and recipients of grafts of cornea, sclera and dura mater, and persons that have undergone undocumented neurosurgery (where dura mater may have been used). For variant Creutzfeldt-Jakob disease, further precautionary measures may be recommended. |
Excluded | |
| Recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist. | Excluded |
Table 9. Additional exclusion criteria for deceased child donors of tissues and cells
| Infection | Exclusion as in Commission Directive 2006/17/EC | Technical guidelines by ECDC |
| HIV 1 and 2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B | Excluded if born from mothers with hepatitis B or at risk of such infection and breastfed by their mothers during the previous 12 months | |
| Hepatitis C | Excluded if born from mothers with hepatitis C or at risk of such infection and breastfed by their mothers during the previous 12 months | |
| HTLV | Excluded if born from mothers with HTLV infection or at risk of such infection and breastfed by their mothers during the previous 12 months |
Table 10. Testing requirements for donors of reproductive cells, partner donations and donations other than by partners
| Infection | Testing requirement as in Commission Directive 2006/17/EC*/** | Technical guidelines by ECDC |
| HIV 1 and 2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B |
HBsAg Anti HBc*** |
|
| Hepatitis C | Anti-HCV-Ab*** | |
| Syphilis | A validated testing algorithm must be applied to exclude the presence of active infection with Treponema pallidum. A non-reactive test, specific or non-specific, can allow 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 | |
| HTLV-I |
HTLV-I antibody testing must be performed for donors living in or originating from high-prevalence (****) areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas |
|
| Chlamydia (*****) | Nucleic Acid Amplification Technique (NAT) on urine sample |
(*) Donor selection criteria and laboratory testing do not need to be applied in the case of partner donation of reproductive cells for direct use.
(**) Positive results will not necessarily prevent partner donation in accordance with national rules.
(***) Sperm donations other than by partners will be quarantined for a minimum of 180 days, after which repeat testing is required. If the blood donation sample is additionally tested by the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample is not required. Retesting is also not required if the processing includes an inactivation step that has been validated for the viruses concerned.
(****) As in Commission Directive 2012/39/EU.
(*****) Only for sperm donors other than by partners.
Table 11. Exclusion criteria for donations other than by partners of reproductive cells
| Infection | Exclusion as in Commission Directive 2006/17/EC | Technical guidelines by ECDC |
| HIV 1 and 2 | Not applicable: Existing technical guidelines by ECDC. |
See ECDC guidelines on HIV |
| Hepatitis B |
When anti-HBc is positive and HBsAg is negative, further investigations are necessary with a risk assessment to determine eligibility for clinical use. Excluded, except in the case of persons with a proven immune status |
|
| Hepatitis C | Excluded | |
| Syphilis | A non-reactive test, specific or non-specific, can allow 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 | |
| HTLVI/II | Excluded | |
| Chlamydia (*) | Excluded |
(*) Only for sperm donors other than by partners.
Breast milk
ECDC has not yet prepared technical guidelines for Donor Human Milk. Guidelines for Donor Human Milk are covered in the EDQM Guide to the quality and safety of tissues and cells for human application, 6th edition which may be referred to in the interim. The IMAGINE-HMB project is preparing EU evidence-based guidelines. None of these guidelines have formally been evaluated by ECDC.
Faecal microbiota
ECDC has not yet prepared technical guidelines for Faecal Microbiota Transplantation. Guidelines for Faecal Microbiota are covered in the EDQM Guide to the quality and safety of tissues and cells for human application, 6th edition which may be referred to in the interim. The HARMONIZE project is preparing EU evidence-based guidelines. None of these guidelines have formally been evaluated by ECDC.