Incidence and window period residual risk of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in United States blood donations, 2017 to 2023: The transfusion-transmissible infections monitoring system.

Background: The Transfusion-Transmissible Infections Monitoring System assesses trends in ~60% of the US blood supply. Donors with high-risk behaviors, including injection drug use, men having sex with other men, or exchanging sex for money/drugs were deferred for 12 months (12M) from 2016 to 2020 and 3 months (3M) from 2020 to 2023. Here we evaluate HIV, HBV, and HCV incidence and window-period residual risk (WPRR) in two ~3-year periods of 12M (2017-2020) and 3M (2020-2023) to identify any differences.

Temporal Trends in Red Blood Cell and Platelet Transfusion Thresholds for Extremely Low Birth Weight Infants.

Objective: To evaluate if hematologic thresholds for red blood cell (RBC) and platelet transfusions changed over time following publication of new evidence from randomized trials in a multicenter cohort of extremely low birth weight (ELBW) infants.

Study Design: We analyzed data from the National Heart Lung and Blood Institute Recipient Epidemiology and Donor Evaluation Study-IV-Pediatrics (REDS-IV-P) study from April 2019 through December 2023. We compared pre-transfusion hemoglobin and platelet counts closest to each transfusion within 24 hours by year using linear mixed models and used model interaction terms to determine if trends over time differed by postnatal weeks.

Genetic modifiers of frequent vaso-occlusive hospitalizations among individuals with sickle cell disease (SCD).

Sickle cell disease (SCD) is characterized by painful vaso-occlusive crises (VOC), which occur due to the adhesion of sickled erythrocytes and leukocytes to the endothelium, leading to vascular obstruction and tissue ischemia. Recurrent VOC increases SCD morbidity, reduces quality of life, and results in frequent hospitalizations. While factors like HbF levels and alpha-thalassemia co-occurrence are known to influence the risk of VOC, the genetic basis of this phenotype remains underexplored.

Mortality from sickle cell disease in Brazil.

Despite early diagnosis through neonatal screening and improved access to vaccines, antibiotics, and disease-modifying therapies, many individuals with sickle cell disease (SCD) die before age 60. This study evaluated causes and independent predictors of mortality in a Brazilian SCD population using data from the multicenter REDS-III cohort [2013-2018], which included six centers. Eligible patients were randomly enrolled during routine visits.

Risk factors for incident human immunodeficiency virus infection in South African blood donors.

Background And Objectives: Recruiting blood donors among a population with a high human immunodeficiency virus (HIV) burden requires detailed information on HIV risks. We studied demographic and behavioural risk factors for incident HIV infection among blood donors in South Africa.

Materials And Methods: We conducted a case-control study.

Risk factors associated with HIV infection in four large Brazilian blood centers: A multicentric case-control study (2009-2017).

Background: Strategies to reduce contamination by transfusion-transmissible infections are constantly evolving. Over the years, HIV residual risk has decreased in several countries. However, in Brazil a recent study showed that the residual risk remains substantially higher than in other countries.

Factors associated with active syphilis infection in US blood donors.

Background: Syphilis is increasing globally, with limited monitoring of risk factors in asymptomatic, low-risk populations. Here, we investigate contemporary demographic and behavioral risk factors associated with active syphilis infection (ASI) in US blood donors.

Study Design And Methods: Beginning with donations in October 2020, four US blood centers implemented standardized risk factor interviews for ASI in blood donors as part of a larger case-control study.

Improved HIV-1 RNA detection using whole blood versus plasma in antiretroviral-treated individuals.

Unlabelled: Currently, nucleic acid testing (NAT) platforms detect HIV-1 in plasma. Using whole blood (WB) could improve HIV-1 detectability as cellular elements may also contain HIV-1 nucleic acids. We used well-characterized paired WB/plasma panels to evaluate HIV-1 RNA detection inhibition by WB, specificity, and enhanced HIV-1 RNA detectability by WB compared to plasma.

Machine-learning models to predict iron recovery after blood donation: a model development and external validation study.

Background: Machine-learning models directly predicting iron biomarkers after blood donation could help to manage donation-associated iron deficiency and avoid low haemoglobin deferrals. No such models have been externally validated internationally. Our aim was to develop and externally validate machine-learning models predicting returning blood donors' haemoglobin and ferritin.

The Red Blood Cell-Improving Transfusions for Chronically Transfused Recipients (RBC-IMPACT) study: protocol description of an international multi-site observational clinical study.

Background: Variability in blood donors, components, and recipients are known to affect transfusion outcomes, yet the combined effects of these factors remains unclear.

Materials And Methods: The Red Blood Cell - Improving Transfusions for Chronically Transfused Recipients (RBC-IMPACT) study was a multi-center longitudinal study conducted in the United States (US) and Brazil over two years to investigate RBC survival after transfusion (Aim 1) and acute increase in iron post transfusion (Aim 2) (see https://clinicaltrials.gov/study/NCT05255445).

Urban versus rural blood donors in the United States and the relationship with transfusion-transmissible infections.

Introduction: Most US blood donations are from donors living in urban areas. Demographics and infectious disease prevalence may vary in urban versus rural areas. We assessed demographic and transfusion-transmissible infection (TTI) prevalence among donors living in urban versus rural areas.

Performance of a whole blood immunoassay for tenofovir detection and correlation with self-reported pre-exposure prophylaxis use in HIV-negative men who have sex with men interested in blood donation.

Background: In 2023, the United States Food and Drug Administration revised its blood donor eligibility policy for men who have sex with men (MSM) from a 3-month deferral to individual assessment. Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP) use remains a reason for deferral, and nondisclosure is a concern.

Study Design And Methods: In a cross-sectional study of sexually active MSM from 8 U.

Detection of SARS-CoV-2 Reinfections Using Nucleocapsid Antibody Boosting.

More than 85% of US adults had been infected with SARS-CoV-2 by the end of 2023. Continued serosurveillance of transmission and assessments of correlates of protection require robust detection of reinfections. We developed a serologic method for identifying reinfections in longitudinal blood donor data by assessing nucleocapsid (N) antibody boosting using a total immunoglobulin assay.

HIV incidence in US first-time blood donors during 12 and 3 month deferral policy periods between 2015 and 2023 before implementation of individual donor assessment.

Background: Following FDA guidance, US blood collectors changed donor deferral for men who have sex with men (MSM) from indefinite to a 12 month deferral in 2016 (12 m), and for MSM and several other exposure risks to 3 month deferrals in 2020 (3 m). We evaluated first-time donor (FTD) HIV incidence and demographics during these periods.

Study Design And Methods: We estimated cross-sectional HIV incidence and incidence rate differences in FTD based on routine donation nucleic acid testing (NAT) and serology with additional limiting antigen (LAg)-Avidity immunoassay and viral load testing.

Clinics and genetics of hyperhemolysis syndrome in patients with sickle cell disease.

Background: Hyperhemolysis syndrome (HHS) is a severe transfusion-related complication with a complex immune pathophysiology, primarily affecting individuals with sickle cell disease (SCD). Limited research has investigated the clinical and molecular risk factors for HHS, which could help identify at-risk patients. This study aimed to assess clinical factors associated with HHS and identify genetic variations that increase susceptibility using a candidate-gene approach.

Blood donor SARS-CoV-2 infection or vaccination and adverse outcomes in plasma and platelet transfusion recipients.

Background: Despite data supporting the safety of SARS-CoV-2 vaccination, concerns regarding the receipt of blood products from donors previously infected or vaccinated against SARS-CoV-2 persist. We assessed whether transfusions of plasma or platelet products from donors with prior SARS-CoV-2 infection or vaccination were associated with adverse outcomes in patients without COVID-19.

Methods: We linked donor SARS-CoV-2 spike and nucleocapsid antibody data and vaccination history to blood products transfused between June 1, 2020 and March 31, 2022.

Assessing HIV trends among blood donors in five Brazilian blood centers: The impact of individual donor assessment.

Background: In many countries, including Brazil, time-based blood donation deferral policies for gay, bisexual, and other men who have sex with men (gbMSM) have been replaced by individual donor assessment (IDA). We examined HIV prevalence and incidence among first-time (FTD) and repeat donors (RD), comparing data from ~3.5 years before and after the IDA policy implementation in 2020.

Syphilis reactivity among blood donors in Brazil: associated factors and implications for public health monitoring.

Background: Increasing syphilis infection rates are a concerning issue worldwide. Blood donation screening is an opportunity to monitor the burden of asymptomatic infections, providing information on contemporary factors associated with infection and public health insights into transmission.

Methods: Blood donations collected at five Brazilian blood centers between January 2020 and February 2022 were screened with treponemal or non-treponemal assays according to local protocols, followed by alternate Enzyme-Linked Immunosorbent Assay (ELISA); samples with reactive or indeterminate results in the alternate ELISA were further tested with the rapid plasma reagin (RPR), and categorized as RPR-positive or RPR-negative.

How do we engage with the lesbian, gay, bisexual, and transgender community in blood donation and research? Reflections from the Assessing Donor Variability and New Concepts in Eligibility study.

Background: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study was a multicenter cross-organizational collaboration to collect data to inform possible changes in blood donor selection criteria for men who have sex with men. Multiple recruitment approaches were used, and these may be applicable to current efforts in LGBTQ+ community engagement to recruit new blood donors.

Methods: Fieldwork for ADVANCE was a partnership between blood collection organizations (BCOs) and LGBTQ+ community organizations.

Transfusion-transmissible coinfections among US blood donors.

Background: Transfusion-transmissible infection (TTI) prevalence among US blood donors has been widely documented. Here we estimate the prevalence of donors presenting with ≥2 TTIs (multiple infections past or present referred to as coinfections) and describe their demographics and associations.

Methods: Data from the Transfusion-Transmissible Infections Monitoring System were compiled for October 2020-September 2023 (3 years).

Adherence to COVID-19 vaccination recommendations and vaccine hesitancy in US blood donors.

Background: General vaccination rates have been falling globally despite unequivocal health benefits. Noncompliance can result from access barriers and/or hesitant attitudes. Few studies have investigated the prevalence and determinants of noncompliance with COVID-19 vaccination in blood donors.

Genetic variants associated with white blood cell count amongst individuals with sickle cell disease.

Background: Sickle cell disease (SCD) is a Mendelian disorder characterized by a point mutation in the β-globin gene that leads to sickling of erythrocytes. Several studies have shown that absolute neutrophil count is strongly associated with clinical severity of SCD, suggesting an apparent role of white blood cells (WBC) in SCD pathology. However, the mechanism by which genetic variants lead to WBC count differences in SCD patients remains unclear.

Suppressed HIV antibody responses following exposure to antiretrovirals-evidence from PrEP randomized trials and early antiretroviral treatment initiation studies.

Background: Exposure to antiretrovirals at or early after HIV acquisition can suppress viral replication and blunt antibody (Ab) responses; a reduced HIV detectability could impact diagnosis and blood donation screening.

Methods: We used three antigen (Ag)/Ab assays and one nucleic acid test (NAT) to analyze samples collected in pre-exposure prophylaxis (PrEP) trials (iPrEx; Partners PrEP) before infection detection by Ab-only rapid diagnostic tests (RDTs), and in early antiretroviral treatment (ART) initiation studies (RV254; SIPP).

Results: Reactivity using NAT and Ag/Ab assays in samples collected up to 8 weeks prior to the first reactive RDT from 251 PrEP trials participants varied between 49-61% for active PrEP users and between 27-37% for placebo users.