2. Updated Screening Criteria for RCDADs
The revised specific guidance outlines updated risk factors and deferral periods. Key changes for HIV, HBV, and HCV include shortened deferral periods for risk factors according to improved testing technologies and findings from large-scale blood donor studies conducted in the U.S., U.K., and Canada. For example:
- The deferral period for persons who have had sex in exchange for money, drugs, or other payments was reduced from five years to three months.
- The deferral period for persons who have undergone tattooing, ear piercing, or body piercing with non-sterile equipment was reduced from twelve months to three months.
- New screening criteria have been introduced to mitigate the risk of false-negative HIV test results associated with antiretroviral drug use. These include a history of HIV treatment, oral pre-exposure prophylaxis (PrEP) use within the past three months, or receipt of long-acting injectable PrEP within the past two years.
3. Donor Medical History Interview
The donor medical history interview is a key step in evaluating donor eligibility. According to FDA recommendations:
- Interviews should be conducted either in person or via telephone. If a written questionnaire is used, it must be followed by a confirmation discussion.
- Records may be documented in paper, audio, or video format and must be accurate, indelible, and legible.
- If a time gap exists between the interview and the sample collection of donors, any changes in the donor’s medical history must be assessed and documented.
4. Advancements in RCDAD Testing Technologies
Considering ongoing advancements in nucleic acid testing (NAT) technologies, the FDA now recommends NAT for most RCDADs to enhance detection sensitivity and reduce the risk of disease transmission through HCT/Ps. Notable testing recommendations include:
- Hepatitis B Virus (HBV): Donor screening must include testing for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and HBV NAT. All three results must be non-reactive for a donor to be considered eligible.
- Human Immunodeficiency Virus (HIV): NAT assays are now capable of detecting HIV-1 group O. Therefore, risk-based deferrals previously applied based on geographic residence, birth, or receipt of blood products in certain countries are no longer required.
Conclusion
This update provides sponsors with clearer recommendations on donor screening and testing criteria to ensure the safety of HCT/Ps.
For additional information on RCDAD risk assessments and updated testing requirements, please refer to the specific guidance documents issued by the FDA.
Reference
- Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV)by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry 2025
- Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry 2025
- Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry 2025
- Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry 2025
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry 2025
