IDM
IDM | Tested | Method | Days between test and sampling/workup |
---|---|---|---|
ALT/ASTALT/AST ratio, De-Ritis-Quotient | Yes | < 30 days | |
ChagasChagas, T. cruzi | On request | < 30 days | |
CMV IgGCytomegalovirus (CMV) Antibody testing IgG | Yes | < 30 days | |
CMV IgMCytomegalovirus (CMV) Antibody testing IgM | Yes | < 30 days | |
CMV TotalCytomegalovirus Total | On request | < 30 days | |
EBV IgGEpstein-Barr Virus Antibody testing IgG | Yes | < 30 days | |
EBV IgMEpstein-Barr Virus Antibody testing IgM | Yes | < 30 days | |
HAV (NAT)Anti-hepatitis A virus nucleic acid testing | On request | < 30 days | |
HBV (NAT)Hepatitis B nucleic acid testing | Yes | < 30 days | |
HBc AbHepatitis B core antibody testing | Yes | < 30 days | |
HBs AgHepatitis B Surface antigen testing | Yes | < 30 days | |
HCV (NAT)Hepatitis C nucleic acid testing | Yes | < 30 days | |
HCV AbHepatitis C antibody testing | Yes | < 30 days | |
HEV (NAT)Hepatitis E Virus nucleic acid testing | On request | < 30 days | |
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing | Yes | < 30 days | |
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing | Yes | < 30 days | |
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing | Yes | < 30 days | |
HIV p24Human Immunodeficiency Virus p24 antigen testing | Yes | < 30 days | |
HTLV-IHuman T-Lymphotropic Virus type I testing | Yes | < 30 days | |
HTLV-IIHuman T-Lymphotropic Virus type II testing | Yes | < 30 days | |
MalariaMalaria | On request | < 30 days | |
HSVHerpes Simplex Virus | On request | < 30 days | |
STSSerological tests for syphilis | Yes | < 30 days | |
STS FTA-ABSSerological test for syphilis | On request | < 30 days | |
ToxoplasmosisToxoplasmosis | Yes | < 30 days | |
VZVVaricella Zoster Virus | On request | < 30 days | |
WNV-NATWest Nile Virus nucleic acid testing | On request | < 30 days | |
Other tests performed | On request | < 30 days |
Testing | |
---|---|
The physical and medical exam at donor workup is performed by a medical doctor: | yes |
All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: | yes |
HLA typing for patient specific request is performed in an appropriately accredited laboratory: | yes |
Sterility testing is performed on the adult donor product: | yes |
Sterility testing is performed on the cord blood product: | yes |
Screening questionnaire to exclude communicable disease: | yes |
Screening questionnaire to exclude donors with 'high risk' lifestyles: | yes |
Donor reliability identified by a medical doctor: | yes |
Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC : | yes |
Customs regulations | |
---|---|
Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify: | Yes, National Regulations |
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify: | Yes, National Regulations |
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify: | Yes, National Regulations |
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify: | Yes, National Regulations |
Reporting of Serious Adverse Events | |
---|---|
Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in: | |
- Mandatory National Reporting Scheme | yes |
- Voluntary National Reporting Scheme | no |
- WMDA SEAR/SPEAR Reporting Scheme | yes |
The registry will notify the receiving Registry within 24 hours of receiving information relating to any serious adverse event that could be considered to affect the patient receiving the product: | yes |
Quality management | |
---|---|
The registry does maintain Standard Operating Procedures for your work: | yes |
The registry would be willing to provide these to WMDA or another registry upon request: | yes |
The registry would be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in: | yes |
Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained: | on a permanent basis |