As an organization dedicated to the safety of the world’s blood and plasma supply, Creative Testing Solutions’ Research & Development team and its research collaborators contribute to studies monitoring emerging and ongoing safety concerns in blood and biologics. For example, CTS continues to provide critical data regarding the safety of the blood supply after donor deferrals for Men who have Sex with Men (MSM) changed in the last few years.
Based on this data and the collective international experience, the Food and Drug Administration (FDA) released earlier this month a new recommendation to move to an individual risk-based assessment for the U.S. We were the testing team for the ADVANCE study and supply data to the FDA-sponsored and National Institutes of Health-funded Transfusion-Transmissible Infections Monitoring System (TTIMS).
Vice President of Scientific Affairs Marion Lanteri recently spoke about the future of blood safety at an international symposium on alternatives to donation deferral hosted by Héma-Québec and Canadian Blood Services. She also gave an interview on the topic for Les Années Lumières by Radio Canada. Dr. Lanteri is uniquely qualified to speak on this topic, having served as the Senior Scientific and Medical Affairs Director for Cerus (whose pathogen reduction system is actively used in blood centers nationwide) and considering her current role at CTS.
Below is a synopsis of how the combined use of blood screening and pathogen reduction technology (PRT) may help further secure plasma and platelet donations against the risk of human immunodeficiency virus (HIV) and hepatitis transfusion transmission (HBV and HCV). An approach like Dr. Lanteri describes may alleviate the need for sexual risk behavior questioning during the donor selection interview soon for plasma and platelet donors and in the future for all donors.
Dr. Lanteri emphasized the importance of maintaining blood safety through multiple strategies, including donor selection and blood screening. She acknowledged the limitations of current methods and proposed the addition of PRT to enhance blood safety and increase the availability of blood products for patients.
In the past decade, blood availability has become a challenge, leading to well-vetted changes in policy, including donor deferrals. For instance, the FDA revised deferrals for MSM, reducing the deferral period from 12 months to 3 months in 2020. The FDA’s decision was based on safety data collected through studies including TTIMS-1 and -2.
Dr. Lanteri described blood screening advancements over the years, significantly reducing the risk of transfusion-transmitted infections like HIV, HBV, and HCV. The residual risk of HIV transmission through transfusion keeps decreasing and is currently very low. Despite this, specific populations, such as sexually active men in the Southern region of the U.S. who become first-time donors, still have higher HIV incidence rates.
Knowing this, Dr. Lanteri also discussed how antiretroviral treatments (ART), pre-exposure prophylaxis (PrEP), and other HIV prevention methods impact HIV blood screening. These treatments can suppress viral loads to undetectable levels, making it challenging to detect infections during the window period — the time between HIV infection and when a test can detect markers of infection in the blood. Dr. Lanteri expressed concerns about blood donors not reporting their HIV status and drug intake during the donor interview.
CTS uses a combination of highly sensitive assays with nucleic acid testing (NAT) and serology for blood screening to address these challenges. However, all screening assays have a detection limit, and some donors may have viral loads below that limit. Dr. Lanteri emphasized that the message of undetectable = untransmissible does not apply to blood safety in the same way it applies to sexual transmission,
Dr. Lanteri proposed adding PRT to improve blood safety. Various technologies have been developed for treating different blood components, such as plasma, platelets, and whole blood, and are in development for red blood cells (RBC). These systems have shown efficacy in inactivating HIV, HBV, HCV, and other pathogens, reducing the risk of transmission through transfusion of contaminated blood products.
While PRT can currently treat platelets and plasma, its use with RBC components is still under development. PRT can address the risk associated with low viral loads that may be undetectable during the window period or under successful ART treatment. NAT addresses anything above the detection limit, including the very high-level viremia observed during peak infection that could be above the PRT inactivation capacity.
Dr. Lanteri emphasized that blood safety without a PRT for red blood cell components relies heavily on NAT and serology. PRT can overcome the limitations of current donor and blood screening methods for platelets and plasma, covering risks associated with sexually transmitted diseases, other viruses, bacteria, and parasites and preparing for emerging infectious disease outbreaks. In the future, when PRT is available for RBC and under universal pathogen reduction, donor selection criteria could be further relaxed, and the removal of questions related to sexual risk and PrEP intake could be considered.
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