Table 2.
Requirement of donor screening test.
| Country/region | Guideline | Donor screening test |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HIV | HBV | HCV | HTLV (Type 1/2) | EBV | PVB 19 |
CMV | WNV | Treponema pallidum | Chlamydia trachomatis | Neisseria gonorrhoeae | TSE/CJD | ||
| China | The requirements about the cell source and donors in China. Quality control of stem cell preparations and guidelines for pre-clinical research (for trial implementation). |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| India | National guidelines for stem cell research (issued by Indian council of medical research – department of biotechnology). Draft guidance document for regulatory approval of SCCP (issued by Central Drugs Standard Control Organization). |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
| Japan | Standards for biological materials (Standard for Human Cell/Tissue materials). Quality and safety assurance for drugs and medical devices manufactured using human (allogeneic) somatic stem cells. |
✓ | ✓ | ✓ | ✓ | ✓1 | ✓ | ✓1 | ✓1 | ✓ | ✓ | ✓ | ✓ |
| Korea | Guideline on eligibility determination for donors of cell therapy products. | ✓ | ✓ | ✓ | ✓2 | ✓2 | ✓ | ✓3 | ✓3 | ||||
| Taiwan | Standard for Human cell therapy product donor suitability. | ✓ | ✓ | ✓ | ✓4 | ✓4 | ✓ | ✓5 | ✓5 | ✓ | |||
| US | Guidance for industry, Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) (21 CFR part 1271). Use of nucleic acid tests to reduce the risk of transmission of west nile virus from living donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). |
✓ | ✓ | ✓ | ✓4 | ✓4 | ✓ | ✓ | ✓1 | ✓1 | ✓ | ||
| EU | Directive 2006/17/EC (Directive 2004/23/EC). | ✓ | ✓ | ✓ | ✓6 | ✓1 | ✓1 | ✓ | ✓ | ||||
1
As needed.
2
To be tested for leukocyte-rich tissue.
3
To be performed only on germ cells or embryo-derived cells.
4
For viable, leukocyte-rich cells or tissue.
5
Reproductive tissue.
6
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.