Terminology
| HPC-A | Peripheral Blood (stem cells, collected by apheresis). |
| HPC-M | Bone marrow (stem cells, collected from bone marrow). |
| MNC-A | Mononuclear cells (collected by apheresis, including starting material for advanced therapy medicinal product (ATMP) manufacture and donor lymphocyte infusions (DLIs)). |
| HPC-CB | Umbilical cord blood. |
| Mandatory | The test is either a regulatory requirement or deemed necessary to ensure regulatory requirements relating to the assessment of donor suitability are met to ensure donor and recipient protection. |
| Discretionary | The test must be performed on certain donors/donations if indicated by medical, social or travel history. |
| Recommended | This test is recommended by an advisory committee or a professional body, but is not a regulatory requirement. |
| Optional | The test is not mandatory and done at the discretion of individual organisations or establishments. This also applies to situations where a mandatory test is repeated at the discretion of individual organisations or establishments. |
Table 1 - Allogeneic HPC-A, HPC-M
| Test | Performed on donor, product or both? | Test mandatory, discretionary, recommended or optional? | Timing of test | Notes |
|---|---|---|---|---|
| ABO + RhD | Donor | Mandatory | Prior to donation | Using two independently collected samples; different needlesticks |
| Mandatory infectious markers | Donor | Mandatory | Within 30 days prior to the donation episode |
See Table 9.2 |
| Optional | At the time of donation or within seven days post donation | |||
| Discretionary Additional infectious markers (e.g. Malaria, WNV, T.cruzi) | Donor | Discretionary | Prior to donation, depending on travel history or residential risk | Align with JPAC Donor Selection Guidelines |
| CMV | Donor | Recommended | At donor selection, and Within 30 days prior to the donation episode |
|
| Toxoplasma | Donor | Recommended | Within 30 days prior to the donation episode | |
| EBV | Donor | Recommended | Within 30 days prior to the donation episode | |
| Pregnancy test | Donor | Discretionary | Seven days prior to starting donor mobilisation regime (G-CSF), and (as applicable) within seven days priot to the initiation of the recipient's preparative regime | Applies to all donors of childbearing potential |
| Haemoglobinopathies | Donor | Discretionary | At the time of donor assessment | Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies |
| Bacteriology testing | Product (processed) | Optional | Pre-processing | |
| Mandatory | Post-processing | |||
| Product (fresh) | Mandatory | Post collection | ||
| FBC | Donor | Mandatory | Immediately before every collection for HPC-A; prior to first donation for HPC-M |
Table 2 - Autologous HPC-A, HPC-M
| Test | Performed on donor, product or both? | Test mandatory, discretionary or optional? | Timing of test | Notes |
|---|---|---|---|---|
| ABO + RhD | Donor | Optional | Prior to donation | Due to autologous nature of product, not essential |
| Mandatory infectious markers | Donor | Mandatory | Within 30 days prior to the donation episode |
April 2023: Sample timing currently under review by HTA. |
| Optional | At the time of donation or within seven days post donation | |||
| Discretionary Additional infectious markers (e.g. Malaria, WNV, T.cruzi) | Donor | Discretionary | Prior to donation, depending on travel history or residential risk | In selected circumstances based on individual risk assessment, testing may be requested/required. Align with JPAC Donor Selection Guidelines. |
| Pregnancy test | Donor | Discretionary | 7 days prior to starting donor mobilisation regime (G-CSF), and, as applicable, within 7 days prior to the initiation of the recipient's preparative regime | Applies to all donors of childbearing potential |
| CMV | Donor | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history |
| Toxoplasma | Donor | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/ required if indicated by donor history |
| EBV | Donor | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/ required if indicated by donor history |
| Haemoglobinopathies | Donor | Discretionary | At the time of donor assessment | Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies |
| Bacteriology testing | Product (processed) | Optional | Pre-processing | |
| Mandatory | Post-processing | |||
| Product (fresh) | Mandatory | Post collection | ||
| FBC | Donor | Mandatory | Immediately before every collection for HPC-A; prior to first donation for HPC-M |
Table 3 - Autologous & Allogeneic MNC-A
| Test | Performed on donor, product or both? | Test mandatory, discretionary, recommended or optional? | Timing of test | Notes |
|---|---|---|---|---|
| ABO + RhD | Donor (allogeneic) | Mandatory | Prior to donation | Using two independently collected samples; different needlesticks |
| Donor (autologous) | Optional | Prior to donation | Due to autologous nature of product, not essential | |
| Mandatory infectious markers | Donor (allogeneic and autologous) | Mandatory | At the time of donation or within seven days post donation1 | See Table 9.2 |
| Discretionary Additional infectious markers (e.g. Malaria, WNV, T.cruzi) | Donor (allogeneic and autologous) | Discretionary | Prior to donation, depending on travel history or residential risk | Align with JPAC Donor Selection Guidelines. For autologous donors in selected circumstances based on individual risk assessment, testing may be requested/required. |
| CMV | Donor (allogeneic) | Recommended | At donor selection, and Within 30 days prior to the donation episode |
|
| Donor (autologous) | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history | |
| Toxoplasma | Donor (allogeneic) | Recommended | Within 30 days prior to the donation episode | |
| Donor (autologous) | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history | |
| EBV | Donor (allogeneic) | Recommended | Within 30 days prior to the donation episode | |
| Donor (autologous) | Optional | Within 30 days prior to the donation episode | In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history | |
| Pregnancy test | Donor (allogeneic and autologous) | Discretionary | Within 7 days prior to collection | Applies to all donors of childbearing potential |
| Haemoglobinopathies | Donor | Discretionary | At the time of donor assessment | Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies |
| Bacteriology testing | Product (processed) | Optional | Pre-processing | |
| Mandatory | Post-processing | |||
| Product (fresh) | Mandatory | Post collection | ||
| FBC | Donor | Mandatory | Immediately before every collection | |
| 1 If MNC are collected at the same time as HPC, the same time specified in Tables 1 and 2 apply | ||||
Table 4 - HPC-CB
| Test | Performed on mother, product or both? | Test mandatory, discretionary, recommended or optional? | Timing of test | Notes |
|---|---|---|---|---|
| ABO + RhD | Product | Mandatory | Prior to cryopreservation | |
| Mandatory infectious markers | Mother | Mandatory | At the time of donation or within seven days post donation | See Table 9.2 |
| Product | Recommended | Prior to release | Testing of the maternal sample at the time of donation, including NAT, may be used as a surrogate marker for the product. Testing of the product is recommended but not mandatory. | |
| Discretionary Additional infectious markers (e.g. Malaria, WNV, T.cruzi) | Mother | Discretionary | 0 to +7 days | Depending on travel history or residential risk. Align with JPAC Donor Selection Guidelines. |
| Product | Discretionary | Prior to release, where applicable | ||
| CMV | Mother | Recommended | 0 to +7 days | |
| Product | Recommended | Prior to release | ||
| Toxoplasma | Mother | Recommended | 0 to +7 days | |
| EBV | Mother | Recommended | 0 to +7 days | |
| Haemoglobinopathies | Product | Discretionary | Prior to release | Sample from product or neonatal screen |
| Bacteriology testing | Product | Mandatory | Post processing, prior to cryopreservation | |
| FBC | Product | Mandatory | Between the end of collection and pre-processing |