欧洲疾控中心-预防通过人类来源物质传播艾滋病毒的准则（英）-2025_60页_2mb

Summary of ECDC Guidelines on the Prevention of HIV Transmission through Substances of Human Origin

Core Content

The European Centre for Disease Prevention and Control (ECDC) has developed guidelines to support the prevention of HIV transmission through substances of human origin (SoHO) intended for human application. These guidelines align with the EU Regulation (EU) 2024/1938 on standards of quality and safety for SoHO and are aimed at professionals in the EU and European Economic Area (EEA) working with SoHO entities, donor selection, and testing.

The guidelines cover three main categories of SoHO:

1. Blood and blood components (e.g., whole blood, red blood cells, plasma, etc.)
2. Tissues and non-reproductive cells (from living or deceased donors)
3. Reproductive cells and tissues (e.g., sperm, oocytes, embryos, etc.)

These guidelines exclude solid organs, faecal microbiota, and breast milk from their scope. They also do not address the protection of recipients from non-HIV-related communicable diseases or quality requirements for preparation and use of SoHO.

Main Objectives

• Prevent HIV transmission from donors to recipients and offspring through medically assisted reproduction (MAR).
• Ensure adherence to the EU Regulation on SoHO standards.
• Provide evidence-based recommendations on donor screening, testing strategies, and actions based on test outcomes.
• Address the limitations of testing, particularly in cases of recent HIV exposure.

Key Recommendations

General Requirements for All SoHO

• Assessment of recent HIV exposure risks is required for all donors at each donation.
• Testing should not occur before a period of at least eight weeks since the last HIV risk event, except in specific cases:
  • Oral PrEP or PEP: at least 12 weeks since last event
  • Injectable PrEP: at least 24 months since last event
• Anti-HIV-1/2 and HIV-1 RNA NAT tests are recommended, with a 95% LOD of 100 IU/mL or below for NAT.
• Look-back procedures should be initiated if a reactive test is found.
• Permanent deferral is required in cases of confirmed HIV positivity.

Blood and Blood Components

• All donors must undergo screening and confirmatory testing for HIV.
• If both screening and confirmatory tests are reactive, the donation should not be released for clinical use.
• If only one test is reactive, the donation should not be released, and the donor should be referred for clinical care.
• In cases where test results are not confirmed positive, the donation may be released after eight weeks, provided the donor is re-evaluated.
• Re-entry without deferral is possible if test results are negative.

Tissues and Non-Reproductive Cells

• Testing requirements are similar to those for blood.
• NAT testing is recommended with a 95% LOD of 100 IU/mL or below.
• Serological tests are also used, and the results are evaluated alongside NAT.
• In case of reactive tests, the donation should not be released, and look-back procedures should be initiated if relevant.
• Re-entry without deferral is possible if results are negative.

Reproductive Cells – Third-Party Donations

• Testing requirements are similar to those for tissues and blood.
• If the donation is quarantined for more than 180 days, only serological tests are required.
• Re-entry without deferral is possible if test results are negative.

Reproductive Tissues and Cells – Within-Partner Use

• Antigen-antibody combination tests are used for HIV-1/2 screening.
• If the screening test is reactive, procedures should be implemented to prevent infection to the partner and their offspring.
• ESHRE guidelines on MAR in patients with viral infections should be followed.

Key Considerations

• HIV transmission risk through SoHO is significant due to the potential for transmission via blood, tissues, and cells.
• Limitations of testing include the window period and the possibility of false negatives or positives.
• Donor re-entry is possible after specific deferral periods if test results are negative.
• Permanent deferral is required for confirmed HIV cases.
• Look-back procedures are initiated in cases of reactive tests to identify and notify potential recipients.
• U=U (Undetectable Equals Untransmittable) is a concept that supports the prevention of HIV transmission when the virus is undetectable in the donor.

Legal and Methodological Background

• The guidelines are based on the EU Regulation (EU) 2024/1938 and support compliance with its standards.
• Evidence synthesis was conducted through structured but non-systematic literature searches.
• Qualitative synthesis was used for most sections, while quantitative analysis was applied to testing methods and pathogen reduction.
• The ad hoc expert panel provided input and reviewed the evidence, with members from various EU/EEA countries.
• The pathogen data sheet contains detailed information on HIV, including virus description, disease progression, testing characteristics, and evidence of transmission.

Next Steps

• The guidelines will be updated to include SoHO intended for industrial manufacturing, such as plasma for fractionation.
• Separate guidance will be developed for HIV transmission through faecal microbiota and breast milk.
• The development process and panel work procedures are detailed in the Annex.

Annex

• Contains legal background, guideline development process, expert panel details, and supporting documents.
• Includes terms of reference, conclusions from expert panel meetings, and pathogen data sheet for HIV.

Conclusion

These guidelines are a critical resource for ensuring the safety and quality of SoHO in the EU/EEA, with a focus on preventing HIV transmission. They provide a structured framework for donor evaluation, testing, and management, and are supported by scientific evidence and expert consensus. The recommendations are designed to be practical and adaptable, allowing for country-specific variations where necessary.