Reducing the risk of infection from plasma products: specific preventative strategies (original) (raw)

Infectious risk of plasma donations: relationship to safety of intravenous immune globulins

Clinical & Experimental Immunology, 1996

Summary Although intravenous immune globulin (IVIG) preparations may be derived from tens of thousands of donations, the residual risk of viral contamination of recovered plasma appears remarkably low, at least for human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Consequently, most pools are unlikely to contain these viruses although the situation is not as well understoof for US-derived source plasma. In addition, routine preparation methods are likely to eliminate infectivity from the relatively fragile HIV. Current plasma screening measures arc generally designed to maintain reasonable titres of anti-HBs in pools, perhaps contributing to the absence of HBV infection. The situation with respect to hepatitis C virus (HCV) is not well understood and it appears that sensitive screening for anti-HCV may have had an impact on the safety of at least one IVIG preparation. The implementation of effective viral inactivation procedures is expected to eliminate any further ris...

Prevention of transfusion-transmitted infections

Blood, 2019

Since the 1970s, introduction of serological assays targeting virus-specific antibodies and antigens has been effective in identifying blood donations infected with the classic transfusion-transmitted infectious agents (TTIs; hepatitis B virus [HBV], HIV, human T-cell lymphotropic virus types I and II, hepatitis C virus [HCV]). Subsequently, progressive implementation of nucleic acid–amplification technology (NAT) screening for HIV, HCV, and HBV has reduced the residual risk of infectious-window-period donations, such that per unit risks are <1 in 1 000 000 in the United States, other high-income countries, and in high-incidence regions performing NAT. NAT screening has emerged as the preferred option for detection of newer TTIs including West Nile virus, Zika virus (ZIKV), and Babesia microti. Although there is continual need to monitor current risks due to established TTI, ongoing challenges in blood safety relate primarily to surveillance for emerging agents coupled with devel...

On the viral safety of plasma pools and plasma derivatives

Journal of the Royal Statistical Society: Series A (Statistics in Society), 2005

In the industrialized world, a range of medicinal products are manufactured on a large scale from pools made of thousands of human blood and plasma donations. Policy makers as well as the general public are aware of the contamination hazards following accumulated risks of individual donations. Today, the manufacturing process must therefore consider a complex sequence of risk reducing interventions, including screening tests and quarantine periods on pools and individual donations. In this paper, we estimate the residual risk of Hepatitis C infection following such sequence of events. This is the most common bloodborne infection in the Western World, which a®ects an estimated 170 million persons worldwide. We investigate the costs and bene¯ts of each intervention and study at several stages the dependence of the screening process on operational parameters that can be optimized, such as the pool size and the length of the quarantine period. This leads to alternative pooling strategies that may be more (cost-)e®ective or optimal under speci¯c criteria.

1a Virus transmission by allogenous blood and blood components

1997

Infectious agents, especially viruses, can be transmitted by human blood products to recipients. Of major importance are viruses such as human immunodeficiency virus 1 and 2 (HIV-1/2), hepatitis B (HBV) and hepatitis C virus (HBC), and human T-cell leukaemia virus type I and II. Also, other viruses such as cytomegalovirus, Epstein-Barr virus, human parvovirus B 19, and hepatitis A and G virus can be transmitted by infected blood products. Various methods are applied to prevent the transmission of blood-borne agents to recipients, for example donor selection, testing for various infectious agents of all blood donations and viral inactivation of plasma derivatives. With all these precautionary measures, the estimated risk for infection by screened blood products in Europe and the USA is approximately l in 50000 to 1 in 600000 (for HBV, HCV and HIV-1/2) per transfused blood product. In the future, the safety of blood products will probably be increased by testing all blood donations with nucleic acid amplification techniques and by (photo)chemical decontamination of cellular blood components.