Abstract
BACKGROUND: The European Union Directives stipulate mandatory tests for the presence of any infections in donors and donations of substances of human origin (SoHO). In some circumstances, other pathogens, including fungi and parasites, may also pose a threat to the microbial safety of SoHO. OBJECTIVE: The aim of the two systematic reviews is to identify, collect, and evaluate scientific evidence for the presence of fungal and parasitic infections in donors and donations of SoHO, and their transmission via transfusion and transplantation. METHODS: An algorithmic search, one each for fungal and parasitic disease, was applied to 6 scientific databases (PubMed, EMBASE, Web of Science, Scopus, Cochrane Library [trials], and CINAHL). Additionally, manual and algorithmic searches were employed in 15 gray literature databases and 22 scientific organization websites. The criteria for eligibility included peer-reviewed publications and peer-reviewed abstract publications from conference proceedings examining the prevalence, incidence, odds ratios, risk ratios, and risk differences for the presence of fungi and parasites in donors and SoHO donations, and their transmission to recipients. Only studies that scrutinized the donors and donations of human blood, blood components, tissues, cells, and organs were considered eligible. Data extraction from eligible publications will be performed independently by two reviewers. Data synthesis will include a qualitative description of the studies lacking evidence suitable for a meta-analysis and a random or fixed-effect meta-analysis model for quantitative data synthesis. RESULTS: This is an ongoing study. The systematic reviews are funded by the European Centre for Disease Prevention and Control, and the results are expected to be presented by the end of 2021. CONCLUSIONS: The systematic reviews will provide the basis for developing a risk assessment for fungal and parasitic disease transmission via SoHO. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020160090; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020160090 ; PROSPERO International Prospective Register of Systematic Reviews CRD42020160110; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020160110. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25674.