Guidelines on the prevention of HIV transmission through substances of human origin

These evidence-based guidelines provide technical requirements and recommendations for evaluating SoHO donors, focusing on the risk of transmitting HIV to recipients and the offspring from MAR. These guidelines provide the minimum SoHO safety requirements to meet the standards in the Regulation. Countries may, however, apply more stringent measures. 

These guidelines aim to provide:

Requirements and recommendations on laboratory testing methods for screening donors for HIV.
Requirements and recommendations on testing strategies for HIV.
Recommendations on events to consider in donor assessment that may lead to laboratory testing limitations.

The content of these guidelines covers SoHO for allogeneic use (meaning the human application of SoHO collected from a person other than the SoHO recipient), as described in the Regulation.

The SoHO Regulation does not apply to solid organs; therefore, organs are outside the scope of these guidelines. Faecal microbiota and breast milk are not included in this iteration of the guidelines. SoHO for autologous use (meaning the human application of SoHO collected from a person to the same person) except for reproductive tissues for autologous use, SoHO for industrial manufacturing, such as plasma for fractionation, pre-analytical considerations, laboratory quality requirements, storage and detailed tests and algorithms for confirmatory testing, are also out of the scope of this iteration of the guidelines.

The current guidelines will be adapted at a later stage to cover the prevention of HIV transmission from donors through SoHO intended for industrial manufacturing, such as plasma for fractionation. The risk of HIV transmission through faecal microbiota and breast milk will be addressed separately. The plans for these adaptations will be published on the ECDC website.

Protection of SoHO recipients and the offspring from MAR other than from transmission of communicable diseases through the application of SoHO, quality requirements for the preparation, use and quality control of blood components, tissues, and cells are not covered in these guidelines. Instead, the European Directorate for the Quality of Medicine and Healthcare (EDQM) Guide to the preparation, use and quality assurance of blood components [3] and Guide to the quality and safety of tissues and cells for human application should be followed.