Testing donations for pathogens and deferring selected blood donors have reduced the risk of transmission of known pathogens by transfusion to extremely low levels in most developed countries. Protecting the blood supply from emerging infectious threats remains a serious concern in the transfusion medicine community. Transfusion services can employ indirect measures such as surveillance, hemovigilance, and donor questioning (defense), protein-, or nucleic acid based direct testing (detection), or pathogen inactivation of blood products (destruction) as strategies to mitigate the risk of transmission-transmitted infection. In the North American context, emerging threats currently include dengue, chikungunya, and hepatitis E viruses, and Babesia protozoan parasites. The 2003 SARS and 2014 Ebola outbreaks illustrate the potential of epidemics unlikely to be transmitted by blood transfusion but disruptive to blood systems. Donor-free blood products such as ex vivo generated red blood cells offer a theoretical way to avoid transmission-transmitted infection risk, although biological, engineering, and manufacturing challenges must be overcome before this approach becomes practical. Similarly, next generation sequencing of all nucleic acid in a blood sample is currently possible but impractical for generalized screening. Pathogen inactivation systems are in use in different jurisdictions around the world, and are starting to gain regulatory approval in North America. Cost concerns make it likely that pathogen inactivation will be contemplated by blood operators through the lens of health economics and risk-based decision making, rather than in zero-risk paradigms previously embraced for transfusable products. Defense of the blood supply from infectious disease risk will continue to require innovative combinations of surveillance, detection, and pathogen avoidance or inactivation. Highlights • A symposium on blood-borne pathogens was held September 26, 2015, in Toronto, Canada. • Transmission-transmitted infections remain a threat to the blood supply. • The residual risk from established pathogens is small; emerging agents are a concern. • Next generation sequencing and donor-free blood are not yet practical approaches. • Pathogen inactivation technology is being increasingly used around the world. • Health economic concerns will likely guide future advances in this area.
【저자키워드】 HIV, Human immunodeficiency virus, health economics, next generation sequencing, transfusion, SARS, Severe acute respiratory syndrome, PCR, polymerase chain reaction, WHO, World Health Organization, Pathogen inactivation, FDA, Food and Drug Administration, WNV, West Nile virus, CMV, cytomegalovirus, transfusion-transmitted infection, blood-borne pathogens, HBV, hepatitis B virus, CHIKV, Chikungunya virus, HCV, hepatitis C virus, NGS, next generation sequencing, NAT, nucleic acid testing, EID(s), Emerging infectious disease(s), HBsAg, surface antigen of the hepatitis B virus, hESC(s), human embryonic stem cell(s), hPSC(s), human pluripotent stem cell(s), HSC(s), hematopoietic stem cells, HSPC(s), hematopoietic stem and progenitor cells, HTLV, human T-lymphotropic virus, iPSC(s), induced pluripotent stem cell(s), PI, pathogen inactivation, QALY, quality adjusted life years, RBC, red blood cell, SURPI, sequence-based ultra-rapid pathogen identification, TT, transfusion transmission, TTI(s), transfusion transmissible infection(s), UCSF, University of California San Francisco, UCSF/AVDDC, UCSF/Abbott Viral Diagnostics and Discovery Center, vCJD, variant Creutzfeldt-Jakob disease,