The presence of fungal and parasitic infections in substances of human origin and their transmission via transfusions and transplantations: A protocol of two systematic reviews (Preprint)
BACKGROUND The European Union Directives stipulate mandatory tests for the presence of some infections in donors or 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 a) fungal and b) parasitic infections in donors and donations of SoHO, and their transmission via transfusion and transplantation. METHODS One algorithmic searching for fungal and one for parasitic diseases were applied in six scientific databases [PubMed; EMBASE; Web of Science; Scopus; Cochrane library (trials); CINAHL]. In addition, manual and algorithmic searches employed in 15 grey literature databases and 22 scientific organisation websites. Selection criteria for eligibility includes peer-reviewed publications and/or peer reviewed abstract publications from conference proceedings, which have examined prevalence/incidence, odds/risk ratios, risk difference of the presence of a) fungal and b) parasitic infections transmission in SoHO donor or donation and their transmission to recipients. Only studies that scrutinised donors and donated human blood, blood components, tissues, cells and organs, were considered as eligible. Data extraction from the eligible publications will be performed independently by two review team members. Data synthesis will include a qualitative description for the studies that will not provide 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 and presents a protocol of two systematic reviews to identify, collect and evaluate scientific evidence for the presence of a) fungal and b) parasitic infections in donors and donations of SoHO, and their transmission via transfusion and transplantation. CONCLUSIONS These systematic reviews will provide a basis for the development of a risk assessment of fungal and parasitic diseases transmission via SoHO. CLINICALTRIAL The systematic reviews have been prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO): CRD42020160090; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=160090 CRD42020160110; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=160110