Guidance on the Safety of Human Cells, Tissues and Organs for Transplantation Regulations: Testing for infectious diseases

These tables are included for reference only.

For details on testing to assess the suitability of CTO donors, including timeframes, refer to sections 18 to 23 (implementation page) of this guidance document.

Table 3: Tissue donors, except ocular tissues
Appropriate and effective infectious disease markers	Mandatory	Recommended
anti-HIV 1	yes	n/a
anti-HIV 2	yes	n/a
HBsAg	yes	n/a
anti-HBc IgG	yes	n/a
anti-HBc IgM	yes	n/a
anti-HCV	yes	n/a
anti-HTLV-I	yes*	n/a
anti-HTLV-II	yes*	n/a
syphilis	yes	n/a
HIV-1 using NAT	yes**	n/a
HCV using NAT	yes**	n/a
WNV using NAT	n/a	yes
Mandatory for donors of leukocyte-rich tissue and recommended for donors of tissues that are not considered to be leukocyte-rich. *Mandatory for tissue from deceased donors. Not necessary for tissue from living donors if the 180-day quarantine and donor retesting protocol is followed. n/a: not applicable

Table 4: Ocular tissues donors
Appropriate and effective infectious disease markers	Mandatory	Recommended
anti-HIV 1	yes	n/a
anti-HIV 2	yes	n/a
HBsAg	yes	n/a
anti-HBc IgG	yes	n/a
anti-HBc IgM	yes	n/a
anti-HCV	yes	n/a
HIV-1 using NAT	yes	n/a
HCV using NAT	yes	n/a
WNV using NAT	n/a	yes
n/a: not applicable

Table 5: Organ or islet cells donors
Appropriate and effective infectious disease markers	Mandatory	Recommended
anti-HIV 1	yes	n/a
anti-HIV 2	yes	n/a
HBsAg	yes	n/a
anti-HBc IgG	yes	n/a
anti-HBc IgM	yes	n/a
anti-HCV	yes	n/a
anti-HTLV-I	yes	n/a
anti-HTLV-II	yes	n/a
toxoplasmosis	yes*	n/a
syphilis	yes	n/a
anti-CMV IgG	yes	n/a
anti-CMV IgM	n/a	yes
Epstein-Barr virus	yes	n/a
HIV-1 NAT	n/a	X**
HCV NAT	n/a	yes**
WNV using NAT	n/a	yes
For heart donors *HIV-1 NAT and HCV NAT are only recommended for living organ donors and high-risk deceased organ donors whose organs will be exceptionally distributed. n/a: not applicable

Table 6: Lymphohematopoietic cells donors
Appropriate and effective infectious disease markers	Mandatory	Recommended
anti-HIV 1	yes	n/a
anti-HIV 2	yes	n/a
HBsAg	yes	n/a
anti-HBc IgG	yes	n/a
anti-HBc IgM	yes	n/a
anti-HCV	yes	n/a
anti-HTLV-I	yes	n/a
anti-HTLV-II	yes	n/a
anti-CMV IgG	yes	n/a
anti-CMV IgM	n/a	yes
syphilis	yes	n/a
HIV-1 using NAT	yes*	yes
HCV using NAT	yes*	yes
WNV using NAT	yes	n/a
*Mandatory for banked lymphohematopoietic cell donation (that is, cord blood) only. n/a: not applicable

Page details

Date modified:: 2024-04-11