Guidance

Chapter 6: collection of material for donor sampling

Updated 21 May 2024

Blood samples should be collected that are appropriate for the required tests. Mandatory tests as required by the European Union Tissues and Cells Directive (EUTCD) and European Union Organ Donation Directive (EUODD) and other recommended standard donor screening tests are summarised in table 1.

Deceased organ and tissue donors

Accurate testing of donor blood samples requires high quality samples of sufficient volume to allow primary testing, confirmation and archiving. In all situations ante-mortem blood samples are preferable.

Where ante-mortem blood samples taken for other purposes exist, these samples (taken up to 7 days preceding death and appropriately stored) are usually preferable to post-mortem samples if samples specifically for the purpose of donor testing cannot be obtained prior to death. Appropriate systems should be in place to make sure samples can be uniquely identified and stored in optimum conditions.

Deceased donor blood sampling and retrieval of tissue for transplantation may happen many hours after circulatory arrest. With time after a donor’s heart stops beating the quality of blood deteriorates, potentially impairing the performance of tests. Post-mortem blood samples should therefore be collected as soon as possible after the donor’s death and, as required by the Quality and Safety Regulations within 24 hours following circulatory arrest.

In order to maximise the quality of the blood samples obtained for testing, they should only be taken by trained staff. The site from which the sample was obtained and the time of sampling must be documented in the donor’s file. Preferred sites for taking samples include cardiac or subclavian puncture and femoral vessel puncture. It is essential to avoid sites close to intravenous lines. The time of death must be recorded.

Table 1: mandatory and recommended screening of organ, tissue and cell donors

Table key:

• M: mandatory tests as required by EUODD and EUTCD
• R: recommended tests
• NR: not required

Infection	Serological test	Organs [note 1]	Tissues [note 2]	HSPC, therapeutic cells (TCs) and human embryonic stem cells [note 2]	Gametes and embryos [note 3]
HIV-1 or HIV-2	Anti-HIV-1/2 Ab/HIV Ag combo	M	M	M	M
HBV	HBsAg	M	M	M	M
HBV	Anti-HBc	M	M	M	M
HCV	Anti-HCV IgG	M	M	M	M
HTLV-1 or HTLV-2	Anti-HTLV1/2 [note 4]	R	M	M	M
HHV-8	Anti-HHV-8	R [note 5]	NR	NR	NR
Syphilis	Anti-Treponema pallidum antibody	R	M	M	M
Toxoplasma gondii	Anti-Toxoplasma gondii IgG	R	NR	R [note 6]	NR
CMV	Anti-CMV IgG	R	NR	R	R
EBV	Anti-EBV IgG	R	NR	R	NR
HEV	HEV RNA	R	R	R	NR
Chlamydia trachomatis	Not applicable	NR	NR	NR	M
Neisseria gonorrhoea	Not applicable	NR	NR	NR	M

Note 1: nucleic acid testing (NAT) tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) are not mandatory for organ transplantation. Pre-donation NAT testing may help reduce the residual risk of infection during the serological window period and may be done on an individual basis.

Note 2: NAT testing is not mandatory for deceased donors of tissues, nor for living donors of tissue and hematopoietic stem and progenitor cells (HSPCs), but it replaces the need for quarantine and the follow-up serological screening.

Note 3: partner donation with direct use (donation and use without any banking) does not require microbiological testing.

Note 4: human T cell lymphotropic virus (HTLV) is not mandatory for all donors of tissues and cells but is 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. There are also requirements for the repeat testing after at least 180 days for those donors at risk of HTLV infection (Human Tissue Authority policy).

Note 5: the SaBTO recommendation is for deceased organ donors. For living donors (and recipients) we suggest that an assessment is carried out by the transplant centre to test for HHV-8.

Note 6: Toxoplasma gondii IgM and IgG required.

Living donors

Organ donation

A blood sample that has been taken up to 30 days before organ donation is considered to meet the requirements for testing, as long as the donor’s risk status has not changed in the time between the sample being taken and the donation.

Tissue donation

For tissues, serological testing of a sample taken on the day of donation or up to 7 days post-donation, and of a subsequent sample taken 6 months later for donors of tissues which may be stored before use, is considered to meet the requirements for testing. In the circumstances of repeat testing, the donation sample can be taken up to 30 days prior to and 7 days post donation. Negative results on NAT testing for HBV, HCV and HIV of a blood sample taken on the day of donation, or up to 7 days after donation, from a seronegative individual abrogate the need to quarantine cryopreserved donations and retest donors after 6 months.

HSPC-cord donation

HSPC-cord donations are usually initially stored un-tested, under conditions that prevent cross-contamination. Cord donations should be quarantined if cryopreservation precedes microbiological testing. A maternal sample taken at the time of donation or up to 7 days prior to donation or up to 7 days post-donation may be used for serological and NAT testing. Donations from infected mothers should be removed from the storage facility as soon as the infection risk is identified. In the case of cord blood banks, if NAT is not performed on the initial maternal sample then it should be policy to retest for relevant microbiological markers before issuing a cord blood unit. In the absence of NAT testing (HIV, HBV and HCV) on the original maternal sample taken at the time of delivery the antibody tests should be repeated on a repeat sample taken at least 180 days or 6 months after delivery. NAT testing can be done on the archived maternal donation sample prior to releasing cord blood unit as an alternative to antibody testing at 6 months. Cord blood donations themselves should undergo microbiological testing prior to use.

HSPC-apheresis or bone marrow donation

For microbiological testing of donors in the setting of HSPC-apheresis or bone marrow donation, a sample from the donor is required on the day of donation or up to 30 days prior to donation.

Gamete and embryo donation

For partner donation of gametes and embryos serological testing of a sample taken within 2 years of the procedure is required. (See Commission Directive 2012/39/EU amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells). Positive tests do not preclude donation.

For non-partner donation sperm, current legislation states that samples must either be stored and repeat serological tests carried out after a minimum of 180 days, or can be released immediately after donation if both serology and NAT tests for HIV, HBV and HCV carried out on the donation blood sample are negative (see Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, Annex 3, 4.3). Further guidance on appropriate testing regimes following non-partner sperm donation are contained in section 16 of the SaBTO Blood, tissue and cell donor selection criteria report: 2017.

Testing of the neonate and infant

When assessing infection status in a deceased donor less than 18 months of age, or older children who have been breastfed within 12 months of donation, the testing requirements depend on the age and any intervention risk that may have led to acquisition of an infection by the neonate or infant.

If the death of the neonate falls within 48 hours of birth, full microbiological screening of the mother is required.

For death between 48 hours and 28 days of birth, if there has been no identifiable intervention in the neonate, the same microbiological screening of the mother applies. If, however, there are identifiable risks (for example, transfusion of blood components or products, or undergoing a surgical procedure) then a full microbiological testing of the mother and NAT testing of the neonate are required.

From 28 days of age up to 18 months or within 12 months of breastfeeding, full microbiological screening of both the infant and the mother are required.

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