Guidelines on the prevention of HIV transmission through substances of human origin : technical guidelines supporting the regulation on standards of quality and safety for substances of human origin intended for human application

These guidelines support adherence to the European Union (EU) Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application. They provide evidence-based recommendations for assessing SoHO donors within the EU and European Economic Area (EEA) with the aim of preventing transmission of the human immunodeficiency virus (HIV) to recipients and offspring from medically assisted reproduction (MAR). HIV poses a significant risk to the safety of SoHO due to its potential transmission through blood, tissues, cells, and organs, as well as the lifelong consequences and severity of the disease. The sustained incidence of HIV in EU/EEA countries underscores the need for a strategic approach to prevent the transmission of HIV from donors via SoHO. The guidelines are divided into three main sections corresponding to different types of SoHO: blood and blood components, tissues and non-reproductive cells, and reproductive cells. Solid organs and SoHO intended for industrial manufacturing are excluded from the scope, as is the protection of SoHO recipients and offspring from MAR other than from transmission of communicable diseases through SoHO. The guidelines were developed by the European Centre for Disease Prevention and Control (ECDC) with the support of a panel composed of experts from EU/EEA countries. These experts provided specific technical and scientific advice to the ECDC. Expert meetings, supported by evidence synthesis, were conducted to inform guideline recommendations. To develop the statements in these guidelines and to support the expert panel, evidence synthesis based on structured literature searches was provided in a pathogen data sheet. This pathogen data sheet contains microbiological and clinical information on HIV, including virus and disease descriptions, epidemiology, test characteristics and testing approaches, and evidence of transmission through SoHO.