Performance of far forward iceless blood storage containers in controlled cold environments.

BACKGROUND: The Golden Hour Box (GHB), an iceless blood container designed for transfusion closest to the point of injury, is used by military medical teams in remote damage control resuscitation. While its performance is well-established in hot environments, it remains underexplored in cold conditions, a significant consideration in emerging global conflict zones. STUDY DESIGN AND METHODS: Four GHBs were preconditioned at +4°C or +18°C for 8 h and subsequently exposed to controlled laboratory simulated temperatures of -5, -15, and -25°C for 100 h. The study focused on their capability to maintain an internal temperature between +2 and +6°C, the recommended range for red blood cells unit storage and transport, using calibrated sensors for precise monitoring. RESULTS: When exposed to negative Celsius temperatures, GHBs showed varied performance depending on preconditioning temperatures. When preconditioned at +4°C, GHBs maintained an internal temperature within the target range (+2 to +6°C) for 100 h at -5°C, 52 ± 1 h at -15°C, and 29 ± 4 h at -25°C. In contrast, the internal temperature of GHBs preconditioned at +18°C exceeded this range in less than 30 min, then dropped below 2°C more rapidly than those preconditioned at +4°C, occurring within 20 ± 2 h at -15 and 13 ± 1 h at -25°C. CONCLUSION: The GHB, when properly preconditioned, effectively maintains internal temperatures suitable for blood product transport in extreme cold. Future research, including analyses of blood performances, is still needed to validate these results in more realistic operational conditions for use in cold environments.

In vitro evaluation of a new viscoelastometry-based point-of-care analyzer.

INTRODUCTION: The VCM is a point-of-care analyzer using a new viscoelastometry technique for rapid assessment of hemostasis on fresh whole blood. Its characteristics would make it suitable for use in austere environments. The purpose of this study was to evaluate the VCM in terms of repeatability, reproducibility and interanalyzer correlation, reference values in our population, correlation with standard coagulation assays and platelet count, correlation with the TEG5000 analyzer and resistance to stress conditions mimicking an austere environment. METHODS: Repeatability, reproducibility, and interanalyzer correlation were performed on quality control samples (n = 10). Reference values were determined from blood donor samples (n = 60). Correlations with standard biological assays were assessed from ICU patients (n = 30) and blood donors (n = 60) samples. Correlation with the TEG5000 was assessed from blood donor samples. Evaluation of vibration resistance was performed on blood donor (n = 5) and quality control (n = 5) samples. RESULTS: The CVs for repeatability and reproducibility ranged from 0% to 11%. Interanalyzer correlation found correlation coefficients (r2) ranging from 0.927 to 0.997. Our reference values were consistent with those provided by the manufacturer. No robust correlation was found with conventional coagulation tests. The correlation with the TEG5000 was excellent with r2 ranging from 0.75 to 0.92. Resistance to stress conditions was excellent. CONCLUSION: The VCM analyzer is a reliable, easy-to-use instrument that correlates well with the TEG5000. Despite some logistical constraints, the results suggest that it can be used in austere environments. Further studies are required before its implementation.

Feasibility of an acoustophoresis-based system for a high-throughput cell washing: application to bioproduction.

BACKGROUND AIMS: These last decades have seen the emergence and development of cell-based therapies, notably those based on mesenchymal stromal cells (MSCs). The advancement of these promising treatments requires increasing the throughput of processed cell for industrialization in order to reduce production costs. Among the various bioproduction challenges, downstream processing, including medium exchange, cell washing, cell harvesting and volume reduction, remains a critical step for which improvements are needed. Typically, these processes are performed by centrifugation. However, this approach limits the automation, especially in small batch productions where it is performed manually in open system. METHODS: An acoustophoresis-based system was developed for cell washing. The cells were transferred from one stream to another via the acoustic forces and were collected in a different medium. The optimal flow rates of the different streams were assessed using red blood cells suspended in an albumin solution. Finally, the impact of acoustic washing on adipose tissue-derived MSCs (AD-MSCs) transcriptome was investigated by RNA-sequencing. RESULTS: With a single passage through the acoustic device at input flow rate of 45 mL/h, the albumin removal was up to 90% while recovering 99% of RBCs. To further increase the protein removal, a loop washing in two steps was performed and has allowed an albumin removal ≥99% and a red blood cell/AD-MSCs recovery of 99%. After loop washing of AD-MSCs, only two genes, HES4 and MIR-3648-1, were differently expressed compared with the input. CONCLUSIONS: In this study, we developed a continuous cell-washing system based on acoustophoresis. The process allows a theoretically high cell throughput while inducing little gene expression changes. These results indicate that cell washing based on acoustophoresis is a relevant and promising solution for numerous applications in cell manufacturing.

Mobile blood depots in ground ambulances in compliance with French legislation: A feasibility study.

BACKGROUND: Prehospital transfusion is a way of improving the management of hemorrhagic shock. In France, prehospital transfusion is struggling to develop, both because of logistical difficulties and particularly restrictive legislation. To comply with this, we propose to store the blood products (BPs) in ground ambulances with refrigerated boxes allowing remote continuous monitoring of storage conditions, called "NelumBox" (Tec4med Lifescience GmbH). To open them, the ambulance's team needs a code that is only given by the Transfusion Center if the request meets all required regulatory criteria. STUDY DESIGN AND METHODS: We conducted a prospective simulation-based feasibility study using dummy BPs. Two ambulances were equipped. Simulations were triggered unexpectedly, including during on-call hours. The ability to quickly access the BPs was the main judgment criterion. The quality of hemovigilance during these simulations was also examined. RESULTS: Twenty-two simulations were performed. The ambulance's team was able to access the BPs in 100% of cases. The average waiting time for receiving the unlocking code was 5 min 27 s (SD = 2 min 12 s, MAX = 12 min 00 s). The transfusion traceability was compliant with regulations in 100% of cases. The transfusion center was able to remotely monitor BPs storage conditions for the entire duration of their stockage in the NelumBox. DISCUSSION: The present procedure is efficient, repeatable, and fast. It guarantees a strict transfusion safety without slowdown a severe trauma management, while complying with French regulations.

An observational study of the blood use in combat casualties of the French Armed Forces, 2013-2021.

BACKGROUND: The French Armed Forces conduct asymmetric warfare in the Sahara-Sahel Strip. Casualties are treated with damage control resuscitation to the extent possible. Questions remain about the feasibility and sustainability of using blood for wider use in austere environments. METHODS: We performed a retrospective analysis of all French military trauma patients transfused after injury in overseas military operations in Sahel-Saharan Strip, from the point of injury, until day 7, between January 11, 2013 to December 31, 2021. RESULTS: Forty-five patients were transfused. Twenty-three (51%) of them required four red blood cells units (RBC) or more in the first 24H defining a severe hemorrhage. The median blood product consumption within the first 48 h, was 8 (IQR [3; 18]) units of blood products (BP) for all study population but up to 17 units (IQR [10; 27.5]) for the trauma patients with severe hemorrhage. Transfusion started at prehospital stage for 20 patients (45%) and included several blood products: French lyophilized plasma, RBCs, and whole blood. Patients with severe hemorrhage required a median of 2 [IQR 0; 34] further units of BP from day 3 to day 7 after injury. Eight patients died in theater, 4 with severe hemorrhage and these 4 used an average of 12 products at Role 1 and 2. CONCLUSION: The transfusion needs were predominant in the first 48 h after the injury but also continued throughout the first week for the most severe trauma patients. Importantly, our study involved a low-intensity conflict, with a small number of injured combatants.

Multicenter evaluation of a high-throughput microarray platform for extensive red blood cell phenotyping and antibody screening.

BACKGROUND: Blood typing and antibody screening are key elements of transfusion safety. However, available single platform, flexible, and affordable technologies are limited, especially for extended phenotyping. Microarray-based technology allows for this extended phenotyping with the flexibility of piecemeal analysis. STUDY DESIGN AND METHODS: This study was conducted in three blood donor laboratories to determine the performance of a high-throughput microarray-based system for ABO, RH1-RH5, and KEL1 typing, ABS and extended phenotyping (RH8, KEL2&3, FY1&2, JK1, MNS3). Specimens were tested simultaneously on local platforms and on the microarray-based system. When discrepancies were identified, resolver testing were performed. RESULTS: In total, 4862 blood samples were tested for standard phenotype, 4257 for antibody screening and 2194 for extended phenotype. Results were available for 92.12% of the samples. The overall percent agreements were: 100% for ABO, 99.8% for RH1, 99.24% for RH2-5 and 99.86% for KEL1, 93.16% for antibody screening, and 99.68% for extended phenotype. CONCLUSIONS: This microarray-based system provides highly comparable results to current CE marked assays. The ability to continuously test 3000 microarrays in 1 day, providing simultaneously both extended RBC phenotyping and antibody detection drives laboratory efficiencies. The results of our study validate the performance of this new technology; however, the percentage of samples without results must be reduced and further analysis is required to interpret the ABS screening performances. This could constitute a real breakthrough in transfusion, making it possible in the long term, on a single platform, to carry out all the analyses necessary for the qualification of donations.

Use of prehospital transfusion by French emergency medical services: A national survey.

BACKGROUND: Major bleeding is the leading cause of preventable mortality among trauma patients. Several studies have recently shown that prehospital plasma transfusion improves the outcomes of severely injured patients. Although no consensus has been reached, prehospital transfusion is regularly considered to reduce avoidable mortality. The objective was to assess the status of prehospital transfusion practices in France. STUDY DESIGN AND METHODS: A national survey among the 378 advance life support emergency teams (SMURs) in metropolitan France was conducted from December 15, 2020 to October 31, 2021. A questionnaire was distributed by e-mail to the physicians in charge of SMURs. The questions addressed the transfusion modalities, labile blood products (LBPs) used, and limitations encountered in implementing transfusion. RESULTS: The response rate was 48%, and 82% of the respondents performed prehospital transfusions. A designated pack was used by 44% of the respondents. The LBPs used were packed red blood cells (100%), of which 95% were group 0 RH:-1, fresh frozen plasma (27%), lyophilized plasma (7%), and platelets (1%). The LBPs were transported in isothermal boxes (97%) without temperature monitoring in 52% of the cases. Nontransfused LBPs were discarded in 43% of the cases. Reported limitations in implementing transfusion were the delivery time (45%), loss of LBPs (32%), and lack of evidence (46%). DISCUSSION: Prehospital transfusion was developed in France but access to plasma remains difficult. Protocols allowing the reutilization of LBPs and improving conservation could limit the waste of a rare resource. Implementing the use of lyophilized plasma could facilitate prehospital transfusion. Future studies will need to specify the role of each LBP in the prehospital setting.

Characterization of antibodies to SARS-CoV-2 in lyophilized plasma prepared with amotosalen-UVA pathogen reduction.

BACKGROUND: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-infected patients exhibit disease ranging from asymptomatic to severe pneumonia, multi-organ failure, and death. convalescent COVID plasma (CCP) from recovered patients with high levels of neutralizing antibodies has demonstrated therapeutic efficacy to reduce the morbidity of coronavirus disease 2019 (COVID-19) in some studies. The development of assays to characterize the activity of CCP to neutralize SARS-CoV-2 infectivity offers the possibility to improve potential therapeutic efficacy. Lyophilization of CCP may increase the availability of this therapy. We hypothesized that SARS-CoV-2 antibody profiles of pooled lyophilized pathogen-reduced CCP from COVID-19-recovered blood donors retains virus-neutralizing efficacy as reported for frozen pathogen-reduced CCP. METHODS: Pooled lyophilized pathogen-reduced plasma was prepared from recovered COVID plasma donors. Antibodies to SARS-CoV-2 were characterized in each donor plasma prior to pathogen reduction and lyophilization and after lyophilization of individual CCP, and in the lyophilized CCP pool. Several complimentary assays were used to characterize antibody levels, neutralizing capacity, and the spectrum of antigen reactivity. The mean values for individual plasma samples and the value in the pool were compared. RESULTS: The mean ratio for antibody binding to SARS-CoV-2 antigens before and after treatment was 0.95 ± 0.22 mean fluorescent intensity (MFI) units. Antibody activity to an array of influenza virus antigens demonstrated a mean activity ratio of 0.92 ± 0.12 MFI before and after treatment. CONCLUSIONS: The antibody activity in pooled pathogen-reduced lyophilized CCPs demonstrated minimal impact due to pathogen reduction treatment and lyophilization.

Prevalence of red blood cell alloantibodies among blood donors in the French Military Blood Institute: A 10-year retrospective study.

BACKGROUND AND OBJECTIVES: Screening for red blood cell alloantibodies (RBC-Ab) is a critical step in ensuring blood transfusion safety performed by blood donation screening laboratories. We aim to evaluate the prevalence of the RBC-Ab among healthy blood donors. MATERIALS AND METHODS: Antibody screening of serum of all voluntary blood donors was performed as a routine immune-haematological procedure by a solid-phase method on a fully automated immunohaematology analyser. Positive sera were further investigated to identify the specificity of RBC-Ab by a commercially available red cell panel. RESULTS: Between January 2012 and December 2021, a total of 212,218 donations were screened for the presence of RBC-Ab, 74% from male donors (n = 157,898) and 26% from female donors (n = 54,320). Mean age at donation time was 32 ± 12 years. A total of 1007 donations were screened positive (0.47%), and 131 were confirmed positive for alloantibodies in their serum, yielding a prevalence of 0.06% (95% confidence interval: 0.05-0.07). Most frequent alloantibodies identified were of RH blood group system (64%), followed by anti-MNS (19%), anti-Kidd and Lewis (6% each) and anti-KEL (4%). The results showed a statistically higher prevalence of alloantibodies in women than men. Our results showed a lower prevalence as compared to the available data, which might be related to our study population. CONCLUSION: The prevalence of positive antibody screening in healthy donors in this study was found to be 0.47%, while the prevalence of alloantibodies was 0.06%. The most common alloantibodies were anti-RH1 (25%) and anti-RH3 (24%).

First transfusion of cold-stored low-titer group O whole blood in the French armed forces.

BACKGROUND: Hemorrhage is the most frequent cause of preventable death in the combat setting. Therefore, early transfusion can improve survival of combat casualties. In the case of hemorrhagic shock, massive transfusion must be performed immediately with high transfusion ratios (i.e., approximately 1:1:1 plasma:platelet:red blood cells). The use of cold-stored low-titer group O whole blood could address this challenging transfusion strategy in combat setting. RESULTS: We present here a clinical case illustrating this strategy of high transfusion ratios, which includes-for the first time in a modern conflict involving French Armed Forces-the use of cold-stored low-titer group O whole blood. A 29-year-old French soldier suffered multiple gunshot wounds. Because of the critical condition of the patient in hemorrhagic shock, successive medical teams initiated an early and massive transfusion, using French lyophilized plasma, red blood cells, cold-stored low-titer group O whole blood, and warm fresh whole blood. CONCLUSION: This case report of a bleeding combat casualty, transfused with cold-stored low-titer group O whole blood for the first time in the French Armed Forces, emphasizes two important points: the importance of clinical assessment in the management of a bleeding patient with hemorrhagic shock and the feasibility of early massive transfusion using cold-stored low-titer group O whole blood.

Step by step transfusion timeline and its challenges in trauma: A retrospective study in a level one trauma center.

BACKGROUND: Hemorrhagic shock is the leading cause of preventable early death in trauma patients. Transfusion management is guided by international guidelines promoting early and aggressive transfusion strategies. This study aimed to describe transfusion timelines in a trauma center and to identify key points to performing early and efficient transfusions. METHODS: This is a monocentric retrospective study of 108 severe trauma patients, transfused within the first 48 h and hospitalized in an intensive care unit between January 2017 and May 2019. RESULTS: One hundred and eight patients were transfused with 1250 labile blood products. Half of these labile blood products were transfused within 3 h of admission and consumed by 26 patients requiring massive transfusion (≥4 red blood cells [RBC] within 1 h). Among these, the median delay from patient's admission to labile blood products prescription was -11 min (-34 to -1); from admission to delivery of labile blood products was 1 min (-20 to 16); and from admission to first transfusion was 20 min (7-37) for RBC, 26 min (13-38) for plasma, and 72 min (51-103) for platelet concentrates. The anticipated prescription of labile blood products and the use of massive transfusion packs and lyophilized plasma units were associated with earlier achievement of high transfusion ratios. CONCLUSION: This study provides detailed data on the transfusion timelines and composition, from prescription to initial transfusion. Transfusion anticipation, use of preconditioned transfusion packs including platelets, and lyophilized plasma allow rapid and high-ratio transfusion practices in severe trauma patients.

Iron deficiency among French whole-blood donors: first assessment and identification of predictive factors.

BACKGROUND: The objectives of this study are to estimate the prevalence of iron deficiency (ID) among French whole-blood (WB) donors to identify factors associated with ID and to generate decision trees. STUDY DESIGN AND METHODS: A prospective National multicentre study was performed on WB donors from March 11, to April 5th, 2019. Samples were selected randomly to perform serum ferritin. ID was defined as ferritin value under 26 ng/ml. All results were stratified by sex. Factors associated with ID were analysed using multivariate logistic regression model. CART algorithm was used for decision trees. RESULTS: Eleven thousand two hundred fifty eight WB donors were included. ID was more frequent in women (39·5%) than in men (18·0%). Among 7200 repeated donors, women below 50 yo had a higher risk (OR = 2·37; [1·97-2·85] IC95) than those above 50 yo. Factors associated with ID were: haemoglobin level under the threshold at donation n-1 except for women and n-2 donation; a low mean corpuscular haemoglobin at n-1 and n-2 donations; a shorter interval since n-1 donation and between n-1 and n-2 donations except for women; and women who had given three or four times in the last year. CART algorithm defined high risk of ID subgroups within three populations of donors, new female donors, repeated male donors and repeated female donors. In these identified subgroups, prevalence of ID was up to 72·1%. CONCLUSIONS: Our study showed the high prevalence of ID among French WB donors, identified well-known and new factors associated with ID and defined algorithms predicting ID in three populations.

SARS-CoV-2 neutralising antibody testing in Europe: towards harmonisation of neutralising antibody titres for better use of convalescent plasma and comparability of trial data.

We compared the performance of SARS-CoV-2 neutralising antibody testing between 12 European laboratories involved in convalescent plasma trials. Raw titres differed almost 100-fold differences between laboratories when blind-testing 15 plasma samples. Calibration of titres in relation to the reference reagent and standard curve obtained by testing a dilution series reduced the inter-laboratory variability ca 10-fold. The harmonisation of neutralising antibody quantification is a vital step towards determining the protective and therapeutic levels of neutralising antibodies.

COVID-19 Repeated Convalescent Plasma Collection: Analysis of 149 Donations from 88 French Military Health Workers.

BACKGROUND: Passive therapy with convalescent plasma (CP) could be an effective and safe treatment option in COVID-19 patients. Neutralizing antibodies present in CP generated in response to SARS-CoV-2 infection and directed against the receptor-binding domain of the spike protein are considered to play a major role in the viral clearance. CP infusion may also contribute to the modulation of the immune response through its immunomodulatory effect. We describe for the first time the effectiveness of a CP collection protocol from repeated donations in young patients. MATERIALS AND METHODS: We enrolled health service workers who experienced mild to moderate COVID-19 and from whom several donations have been collected. No minimal severity threshold and no biological cure criteria were required. Donors could return to a second plasma donation 14 days after the first donation. A minimal neutralizing antibody titer of 1:40 was considered for clinical use. RESULTS: Eighty-eight donors were included (median age 35 [28-48] years, 41 women), and 149 plasma products were collected. COVID-19 were mainly WHO stage 2 infections (96%). Among the 88 first donations, 76% had neutralizing antibody titers higher than or equal to 1:40. Eighty-eight percent of donors who came for a second donation had a neutralizing antibody titer of 1:40. Median durations were 15 (15-19) and 38 (33-46) days from the first to the second donation and from recovery to the second donation, respectively. Sixty-nine percent of donors who came for a third donation had a neutralizing antibody titer of 1:40. Median durations were 16 (13-37) and 54 (49-61) days from the second to the third donation and from recovery to the third donation, respectively. No significant difference was observed between the IgG ratio and the age of the donors or the time between recovery and donation. The average IgG ratio did not significantly vary between donations. When focused on repeated blood donors, no significant differences were observed either. CONCLUSION: The recruitment of young patients with a mild to moderate CO-VID-19 course is an efficient possibility to collect CP with a satisfactory level of neutralizing antibodies. Repeated donations are a well-tolerated and effective way of CP collection.

The evolving blood donor deferral policy for men who have sex with men: impact on the risk of HIV transmission by transfusion in France.

BACKGROUND: Blood donation deferral for men who have sex with men (MSM) in France was reduced from permanent to 12 months in July 2016. To inform a further reduction of the deferral period, an HIV risk assessment was conducted with two scenarios: S1, 4-month deferral; S2, 4-month deferral only in the case of more than one sexual partner (i.e., similar to other blood donors). METHODS: Baseline HIV residual risk (RR) was calculated from July 2016 to December 2017, using the Incidence Rate-Window Period method. The impact of both scenarios on RR was assessed using data from surveys on MSM and blood donors, to estimate 1) the number of additional MSM expected to donate in each scenario and 2) HIV incidence among these donors. RESULTS: Baseline HIV RR was estimated at 1 in 6,380,000 donations. For S1, an additional 733 MSM donors, and an additional 0.09 HIV-positive donations were estimated, yielding an unchanged RR of 1 in 6,300,000. For S2, these numbers were estimated at 3102 and 3.92, respectively, yielding an RR of 1 in 4,300,000. Sensitivity analyses showed that, under worst-case assumptions, the RR would equal 1 in 6,225,000 donations for S1 and 1 in 3,000,000 for S2. CONCLUSION: For both scenarios, the HIV RR remains very low. For S1, the risk is identical to the baseline RR. For S2, it is 1.5 times higher, and sensitivity analysis shows that this estimate is less robust than for S1. The French Minister of Health announced that S1 will be implemented in April 2020.

Five years of prolonged field care: prehospital challenges during recent French military operations.

BACKGROUND: French military operations in the Sahel conducted since 2013 over more than 5 million square kilometers have challenged the French Military Health Service with specific problems in prolonged field care. STUDY DESIGN AND METHODS: To describe these challenges, we retrospectively analyzed the prehospital data from the first 5 years of these operations within a delimited area. RESULTS: One hundred eighty-three servicemen of different nationalities were evacuated, mainly as a result of explosions (73.2%) or gunshots (21.9%). Their mean number evacuation was 2.2 (minimum, 1; maximum, 8) per medical evacuation with a direct evacuation from the field to a Role 2 medical treatment facility (MTF) for 62% of them. For the highest-priority casualties (N = 46), the median time [interquartile range] from injury to a Role 2 MTF was 130 minutes [70 minutes to 252 minutes], exceeding 120 minutes in 57% of cases and 240 minutes in 26%. The most frequent out-of-hospital medical interventions were external hemostasis, airway and hemopneumothorax management, hypotensive resuscitation, analgesia, immobilization, and antibiotic administration. Prehospital transfusion (RBCs and/or lyophilized plasma) was started three times in the field, two times during helicopter medical evacuation, and five times in tactical fixed wing medical aircraft. Lyophilized plasma was confirmed to be particularly suitable in these settings. One of the specific issues involved in lengthy prehospital time was the importance to reassess and convert tourniquets prior to Role 2 MTF admission. CONCLUSION: Main challenges identified include reducing evacuation times as much as possible, preserving ground deployment of sufficiently trained medics and medical teams, optimization of transfusion strategies, and strengthening specific prolonged field care equipment and training.

Context and social perceptions of blood donation in donors found positive for human immunodeficiency virus in France.

BACKGROUND: In France, information collected during postdonation interviews showed that a majority of human immunodeficiency virus (HIV)-infected donors were not eligible to donate as per donor selection criteria. In the interest of blood safety, this study aimed to explore the mechanisms of noncompliance with blood donor selection criteria, notably the permanent deferral of men who have sex with men (MSM). STUDY DESIGN AND METHODS: Semistructured individual interviews were conducted with 32 blood donors found positive for HIV between mid-2011 and 2014. Topics such as the experience and motivations for donating blood, understanding of selection criteria, sexual risk management, and opinions on donor selection were discussed. Transcripts were analyzed inductively. RESULTS: More than 50% of study participants were noncompliant with donor selection criteria. Reasons for nondisclosure of risk factors in the predonation questionnaire or the predonation interview included stigma, test-seeking motivations, symbolic attachment to blood donation, and context of donation. Compliance to donor criteria was seen as secondary by donors who reaped personal benefits from the symbolism of their donation. Donors lacked self-reflexivity in their assessment of risky sexual behavior. The "window period" and the underlying epidemiologic arguments for donor selection criteria were poorly understood. Nearly all participants disapproved of the permanent ban on blood donations from MSM. CONCLUSION: This study demonstrated the need for more communication on the epidemiologic basis for donor selection criteria and on the window period to facilitate donor compliance. These findings have already advanced improvements to predonation documents, in a larger context of 2016 donor selection criteria revision.