Using routine health-care data to search for unknown transfusion-transmitted disease: a nationwide, agnostic retrospective cohort study.

BACKGROUND: Identification and prevention of transfusion-transmitted disease is essential for blood transfusion safety. However, current surveillance systems are largely driven by reports of sentinel events, which is an approach that might be inadequate for identifying transmission of pathogens not known to be transmissible or pathogens with long incubation periods. Using a combination of health-data registers and blood-bank databases, we aimed to perform an agnostic search for potential transfusion-transmitted diseases and to identify unknown threats to the blood supply. METHODS: In this nationwide, agnostic retrospective cohort study, we developed a systematic algorithm for performing a phenome-wide search for transfusion-transmitted disease without consideration of any a-priori suspicion of blood-borne transmissibility. We applied this algorithm to a nationwide Swedish transfusion database (SCANDAT-3S) to test for possible transmission of 1155 disease entities based on all relevant diagnostic coding systems in use during the period. We ascertained health outcomes of blood donors and transfusion recipients from the Swedish National Inpatient Register, Swedish Cause of Death Register, and Swedish Cancer Register. Analyses were two-pronged, studying both disease diagnosis concordance between donors and recipients and a possible shared increased disease risk among all recipients of a given donor. For both approaches, we used Cox proportional hazards regression models with time-dependent covariates. Adjustment for multiple comparisons was done using a false discovery rate method. FINDINGS: The analyses included data on 1·72 million patients who had received 18·97 million transfusions (red blood cell, plasma, platelet, or whole blood units) between Jan 1, 1968, and Dec 31, 2017, from 1·04 million blood donors. The median follow-up was 4·5 (IQR 0·9-11·4) years for recipients and 18·5 (8·3-26·2) years for donors. We found evidence of transfusion-transmission for 15 diseases, of which 13 were validated using a second conceptually different approach. We identified transmission of viral hepatitis and its complications (eg, oesophageal varices) but also transmission of other conditions (eg, pneumonia of unknown origin). The diseases that could not be validated in this second approach, HIV and abnormal findings in specimens from male genital organs, were not statistically significant after adjustment for multiple testing. The effect sizes were small (close to 1) for other conditions. INTERPRETATION: We find no strong evidence of unexpected, widespread transfusion-transmitted disease. This novel approach serves as a proof-of-concept for agnostic, data-driven surveillance for transfusion-transmitted disease using routinely collected blood-bank and health-care data. FUNDING: Department of Health and Human Services, US National Heart, Lung, and Blood Institute, US National Institutes of Health, Swedish Research Council and Region Stockholm.

Standardization of a multiplex assay to identify weak D types in a mixed-race Brazilian population.

RH allele variability is caused by several types of variants, resulting in altered RhD and RhCE phenotypes. Most of the weak D phenotypes in European-derived populations are weak D types 1, 2, or 3, which are not involved in alloimmunization episodes. However, the Brazilian population is racially diverse, and the accuracy of molecular and serologic tests developed in recent years has allowed for the identification of other RH variants, that are common in the Brazilian population, such as weak D type 38 or weak partial 11, the latter involved in alloimmunization cases. Furthermore, patients with these two weak D variants must be transfused with D- red blood cell units, as do patients with weak D type 4 or DAR, which are also common D variants in Brazil. Weak D type 38 and weak partial 11 can be serologically misclassified as weak D types 1, 2, or 3 in patients, based on European experience, or as D- in donors. Additionally, pregnant women may unnecessarily be identified as requiring Rh immune globulin. RhCE phenotypes are reliable indicators of RhD variants. For individuals with the Dce phenotype, the preferred approach is to specifically search for RHD*DAR. However, when encountering DCe or DcE phenotypes, we currently lack a developed method that assists us in rapidly identifying and determining the appropriate course of action for the patient or pregnant woman. Two multiplex assays were proposed: one for the identification of RHD*weak partial 11, RHD*weak D type 38, and RHD*weak D type 3 and another for RHD*weak D type 2 and RHD*weak D type 5. The multiplex assays were considered valid if the obtained results were equivalent to those obtained from sequencing. Expected results were obtained for all tested samples. The proposed multiplex allele-specific polymerase chain reaction assays can be used in the molecular investigation of women of childbearing age, patients, and blood donors presenting a weak D phenotype with DCe or DcE haplotypes in a mixed-race population, such as Brazil.

Relevance of haemoglobin monitoring in apheresis plasma donors: A retrospective cohort study in Québec, Canada.

BACKGROUND AND OBJECTIVES: Systematically measuring pre-donation haemoglobin (Hb) levels might be overly cautious for apheresis plasma donation, since plasmapheresis entails a small loss of red blood cells. We explored the association between the frequency of apheresis plasma donation and capillary blood Hb levels. MATERIALS AND METHODS: This retrospective cohort study included donors who gave apheresis plasma at least twice between 24 October 2020 and 23 October 2022 in Québec, Canada. Results were stratified by sex and analysed with linear repeated-measure mixed models with random intercepts. RESULTS: In total, 9535 men (mean age = 46.7 years) and 9409 women (mean age = 41.1 years) made ≥2, but no more than 16 apheresis plasma donations. Over an average of 9.2 months of observation, men maintained Hb levels well above the Hb deferral threshold, and their Hb levels decreased by only 0.17 g/dL between the 1st and 15th donation return (p < 0.0001). Over an average of 9.0 months of observation, women also maintained adequate Hb levels, and their Hb levels decreased by 0.08 g/dL between the 1st and 15th donation return. CONCLUSION: The frequency of apheresis plasma donation was not associated with clinically meaningful changes in Hb levels, neither in men nor in women. This evidence questions the relevance of systematically monitoring Hb for apheresis plasma donation, at least for donation frequencies of ≤7-8 times per year. However, an adverse impact of plasmapheresis on Hb levels cannot be ruled out for individuals donating more frequently or for longer than ~9 months.

Supplemental findings of the 2021 National Blood Collection and Utilization Survey.

BACKGROUND: The Department of Health and Human Services' National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and use. Supplemental data from the 2021 NBCUS not presented elsewhere are presented here. METHODS: Data on survey participation, donor characteristics, blood component cost, transfusion-associated adverse reactions, and implementation of blood safety measures, including pathogen-reduction of platelets, during 2021, were analyzed. Comparisons are made to 2019 survey data where available (2013-2019 for survey participation). RESULTS: During 2021, there were 11,507,000 successful blood donations in the United States, a 4.8% increase from 2019. Persons aged 45-64 years accounted for 42% of all successful blood donations. Donations by persons aged 65 years and older increased by 40.7%, while donations among minorities and donors aged <25 years decreased. From 2019 to 2021, the median price hospitals paid per unit of leukoreduced red blood cells, leukoreduced and pathogen-reduced apheresis platelets, and fresh frozen plasma increased. The largest increase in price per unit of blood component in 2021 was for leukoreduced apheresis platelets, which increased by ~$51. Between 2019 and 2021, the proportion of transfusing facilities reporting use of pathogen-reduced platelets increased, from 13% to 60%. Transfusion-related adverse reactions declined slightly between 2019 and 2021, although the rate of transfusion-transmitted bacterial infections remained unchanged. CONCLUSION: During 2021, blood donations increased nationally, although donations from those aged <25 years and minorities declined. The prices hospitals paid for most blood products increased, as did the use of pathogen-reduced platelets.

Effects of donation frequency on U.S. source plasma donor health.

BACKGROUND: Plasma-derived medicinal products (PDMPs) are essential, life-saving medicines manufactured from plasma donated by healthy human volunteers. PDMPs are used to treat a range of rare, serious, and chronic conditions, often genetic in origin. Approximately 70% of the Source Plasma (SP) used for PDMP manufacturing comes from United States (US). The hypothesis of the study is that US donation frequency does not impair donor self-reported functional health and well-being. STUDY DESIGN AND METHODS: A total of 5608 SP donors from 14 US SP centers were enrolled in a cross-sectional study to assess self-reported health related quality of life (HRQoL) and well-being. By sex, donors were assigned to one of four groups, according to their frequency of SP donation in the 12 months before enrollment. The SF-36v2® Health Survey (SF-36v2) and a survey assessing the frequency of various health conditions that may be associated with impaired immune function over different time periods were used. RESULTS: There were no statistically significant differences in SF-36v2 scores between any of the donor frequency groups, compared with new donors after controlling for potential confounding and accounting for multiple comparisons among males and females. Cough, cold, occasional fatigue, and sore throat were the most reported health conditions or symptoms, but there was no clear difference among sex or frequency groups. DISCUSSION: The self-reported data in this study support the hypothesis that compensated donations at US FDA permitted frequencies and volumes are consistent with maintaining donor health. Compared with the general population, SP donors have comparable or better health than the general population.

Prevention of multiple whole blood donations by an individual at the same month through the creation of a national Deferred Donor Registry (DDR).

INTRODUCTION: The Colombian National Institute of Health administers the National Information System of Haemovigilance (SIHEVI-INS). Today, SIHEVI-INS constitutes a national blood donor and recipient database, which contains a national deferred donor registry (DDR), allowing blood banks to take acceptance or rejection decisions of a potential donor in real time. The study aimed to determine the rate of people who have made more than one whole blood donation monthly in Colombia, violating the national guideline of intervals between donations (three months for men and four for women), since DDR implementation. METHODS: We detected the unique personal identification number of people who, in 30 calendar days, made more than one whole blood donation at any of the 83 blood banks set up in Colombia. There were three comparison periods: 01/01/2018-08/31/2019 (launch of SIHEVI-INS and first national feedback); 09/01/2019-12/31/2020 (second feedback) and 01/01/2021-09/30/2022 (massive incorporation of web services). RESULTS: For the first period, blood banks accepted 18.0 donations per 1000 people. There was a rate of 28.8 people/10,000 donations who had donated whole blood twice within 30 days. In the second period, there were 17.0 donations/1000 people and a rate of 2.1 people/10,000 donations (OR:14.0 CI95 %:12.2-16.0). For the last period, there were 18.2 donations/1000 people and a rate of 0.9 individuals/10,000 donations (OR:31.3 CI95 %:26.6-36.9, p < 0.001). CONCLUSION: DDR reduced by 31 times the acceptance of blood donors who made more than one whole blood donation in the same month. It was necessary to provide periodic feedback and promote web service implementation to reduce this risky behavior.

Frequency of the DI*A, DI*B and Band 3 Memphis polymorphism among distinct groups in Brazil

ABSTRACT Introduction: The Band 3 is a red blood cell protein that carries the Dia and Dib antigens from the Diego blood system. The SLC4A1 gene encodes Band 3; Band 3 Memphis is a polymorphism of normal Band 3 and has two variants, but only the variant II carries the Dia antigen. Objectives: Describe the frequencies of the DI*A and DI*B alleles and the Band 3 Memphis among blood donors, sickle cell disease (SCD) patients and Amazonian Indians. Methods: A total of 427 blood samples were collected and separated into three groups: 206 unrelated blood donors, 90 patients with SCD and 131 Amazonian Indians. We performed DI*A/B, normal Band 3 and Band 3 Memphis genotyping, using the Polymerase Chain Reaction Restriction Fragment Length Polymorphism (PCR-RFLP). Results: The frequency of the DI*A/DI*A genotype was 0.5% in blood donors and it was not found in other groups. The frequency of the DI*A/DI*B was higher in Amazonian Indians (33.6%) and the frequency of the DI*B/DI*B was highest in blood donors (92.2%). All 105 individuals tested were positive for the presence of normal Band 3 and of these individuals, only 5/105 (4.8%) presented the Band 3 Memphis mutation. Conclusion: We observed a higher frequency of the DI*B allele in blood donors and a low frequency of the DI*A/DI*A genotype in all groups studied. The Band 3 Memphis was found in a higher frequency in the blood donor group. Our findings highlight the importance of analyzing different population groups to gain a better understanding of the genetic association of blood group antigens.

Sickle cell disease and the need for blood: Barriers to donation for African, Caribbean, and Black young adults in Canada.

BACKGROUND: Many blood operators around the world face the challenge of increasing the number of donors of African ancestry to meet the transfusion needs of people living with sickle cell disease. This article reports results of the barriers to blood donation for young adults (aged 19-35) in Canada who identify as African, Caribbean, or Black. STUDY DESIGN AND METHODS: A community-based qualitative study was conducted by researchers from community organizations, blood operator, and universities. In-depth focus groups and interviews (n = 23) were conducted from Dec 2021 to Apr 2022 and thematic analysis was completed. RESULTS: Applying a socio-ecological model, multiple levels of interacting barriers to blood donation were identified. These included macro-level barriers (e.g., systemic racism, mistrust of the healthcare system, sociocultural beliefs and views about blood and sickle cell disease), mezzo-level barriers (e.g., deferral criteria, minimum hemoglobin levels, donor questionnaire, access, parental concerns), and microlevel barriers (e.g., limited knowledge of blood needs for people with sickle cell disease, lacking information about blood donation process, fear of needles, personal health concerns). DISCUSSION: This study is the first to focus on barriers to donation for African, Caribbean, and Black young adults across Canada. Parental concerns, informed by parents' experiences of inequitable healthcare and mistrust, emerged as a novel finding in our study population. Results suggest that higher order (macro-level) barriers influence and may reinforce lower order (mezzo- and microlevel) barriers. As such, interventions aimed at addressing barriers to donation should keep in view all levels with particular attention paid to higher order barriers.

Effect of Donor Sex on Recipient Mortality in Transfusion.

BACKGROUND: Conflicting observational evidence exists regarding the association between the sex of red-cell donors and mortality among transfusion recipients. Evidence to inform transfusion practice and policy is limited. METHODS: In this multicenter, double-blind trial, we randomly assigned patients undergoing red-cell transfusion to receive units of red cells from either male donors or female donors. Patients maintained their trial-group assignment throughout the trial period, including during subsequent inpatient and outpatient encounters. Randomization was conducted in a 60:40 ratio (male donor group to female donor group) to match the historical allocation of red-cell units from the blood supplier. The primary outcome was survival, with the male donor group as the reference group. RESULTS: A total of 8719 patients underwent randomization before undergoing transfusion; 5190 patients were assigned to the male donor group, and 3529 to the female donor group. At baseline, the mean (±SD) age of the enrolled patients was 66.8±16.4 years. The setting of the first transfusion was as an inpatient in 6969 patients (79.9%), of whom 2942 (42.2%) had been admitted under a surgical service. The baseline hemoglobin level before transfusion was 79.5±19.7 g per liter, and patients received a mean of 5.4±10.5 units of red cells in the female donor group and 5.1±8.9 units in the male donor group (difference, 0.3 units; 95% confidence interval [CI], -0.1 to 0.7). Over the duration of the trial, 1141 patients in the female donor group and 1712 patients in the male donor group died. In the primary analysis of overall survival, the adjusted hazard ratio for death was 0.98 (95% CI, 0.91 to 1.06). CONCLUSIONS: This trial showed no significant difference in survival between a transfusion strategy involving red-cell units from female donors and a strategy involving red-cell units from male donors. (Funded by the Canadian Institutes of Health Research; iTADS ClinicalTrials.gov number, NCT03344887.).

Use of selective phenotyping and genotyping to identify rare blood donors in Canada.

BACKGROUND AND OBJECTIVES: The distribution of rare and specific red cell phenotypes varies between races and ethnicities. Therefore, the most compatible red cell units for patients with haemoglobinopathies and other rare blood requirements are most likely to be found in donors from similar genetic backgrounds. Our blood service introduced a voluntary question asking donors to provide their racial background/ethnicity. Results triggered additional phenotyping and/or genotyping. MATERIALS AND METHODS: We analysed the results of additional testing performed between January 2021 and June 2022, and rare donors were added to the Rare Blood Donor database. We determined the incidence of various rare phenotypes and blood group alleles based on donor race/ethnicity. RESULTS: Over 95% of donors answered the voluntary question; 715 samples were tested, and 25 donors were added to the Rare Blood Donor database, including five k-, four U-, two Jk(a-b-) and two D- - phenotypes. CONCLUSION: Asking donors about their race/ethnicity was well received by donors, and the resulting selective testing enabled us to identify individuals with a higher likelihood of being rare blood donors, support patients with rare blood requirements and better understand the incidence of common and rare alleles and red blood cell phenotypes in the Canadian donor population.

Examining participant representation by sex, race, ethnicity and age in United States blood donation and blood transfusion clinical trials.

Significant inequities based on sex, race, ethnicity, and age exist among participants in clinical trials dedicated to investigating medical disease states. While general demographic data regarding blood donors and blood transfusion recipients have been studied extensively, the demographics of participants involved in blood donation and blood transfusion clinical trials are unknown. We performed a cross-sectional analysis of United States (U.S.) -based interventional blood donation and blood transfusion clinical trials registered with Clinicaltrials.gov to ascertain the composition of participants' sex, race, ethnicity, and age, as well as diagnostic conditions and geographic trial locations.Eligible trials were undertaken between July 2003 and August 2020. Thirty-eight of the one hundred and fifty-two blood donation and blood transfusion clinical trials met inclusion criteria (seven blood donation and thirty-one blood transfusion trials). While the participant dataset from trial reports were incomplete, 100 % of blood donation trials reported sex and age, 71.4 % reported race, and 42.3 % reported ethnicity. 96.8 % of blood transfusion trials reported sex, 51.6 % reported race, 38.7 % reported ethnicity, and 100 % reported age. Among 2720 participants enrolled in the seven blood donation trials, females were underrepresented (28.5 %) compared to U.S. Census data. Conversely, female (50.8 %) and male participants (49.2 %) were equally represented in blood transfusion trials (9255 participants). White participants were overrepresented in blood donation trials (73.4 %), while Hispanic or Latinos were underrepresented in both blood donation (7.7 %) and blood transfusion (8.2 %) trials compared to 2019 U.S.Census data. Only 8.3 % of blood transfusion clinical trials open to adults reported including older adults (i.e., ≥ 65yo). Despite mandatory reporting requirements and an already established framework, researchers frequently failed to report complete demographics of blood donation and blood transfusion clinical trial participants. Furthermore, various demographic groups were underrepresented in blood donation and/or blood transfusion clinical trials, including females, Hispanic or Latino individuals, and older adults. These findings demonstrate the need for implementation of strategies to ensure equitable representation of individuals in blood donation and transfusion clinical trials.

Black and non-black population: investigation of the difference in butyrylcholinesterase activity in a healthy population in Salvador, Bahia.

INTRODUCTION: Butyrylcholinesterase (BChE), an important biomarker of exposure to anticholinesterases, varies its activity according to the intensity and duration of exposure to these agents. Their normal values may vary in different populations. It is important to determine the reference values for the local population, mostly black/brown. OBJECTIVE: The objective was to investigate the baseline values of BChE activity in a sample of the Salvador city population (Bahia, Brazil), evaluating the sociodemographic characteristics. METHOD: A descriptive, quantitative study with a cross-sectional approach was carried out in 304 voluntary and healthy blood donors. BChE activity was determined using the integrated chemical system Dimension RxLMax and analyses of sociodemographic characteristics were performed. RESULTS: For the 304 participants (18 to 67 years old), BChE activity values range were 7.4 to 19.8 U/mL (male) and 6.0 to 19.6 U/mL (female), without significant inter-racial differences (p = 0.986; Mann-Whitney). The participates were predominantly black (44.7%) and brown (40.5%), with higher levels of BchE activity in males (64.8%) (p-value = 0.01) than females (35.2%). There was no relationship between alcohol use and lower BChE activity (p = 0.725, Mann-Whitney). Women using hormonal contraceptives had a median activity 9.2% lower than the non-users. CONCLUSION: Despite the high miscegenation and predominance of the black race in Salvador, contrary to what was expected, the sample did not show statistically significant intra-racial differences in BChE activity, being able to use the same reference values currently used, observing factors such as sex, use of contraceptives, and drinking alcohol.

How do I provide rare red cells to patients?

BACKGROUND: The demand for rare blood is expected to increase in Canada as its population continues to expand through immigration from diverse regions of the world. MATERIAL AND METHODS: This paper outlines a national approach to providing rare red cells for patients through the Rare Blood Program of Canadian Blood Services (CBS). Data detailing the rare red cell requests and inventory managed by CBS' Rare Blood Program is provided. RESULTS: The provision of rare red cells involves multiple considerations such as multidisciplinary communication, serologic/molecular confirmation, donor recruitment, inventory optimization and logistical factors. CONCLUSION: The description of CBS' Rare Blood Program will inform others that seek to create, optimize, or expand programs that facilitate the provision of rare blood. New technologies such as next-generation sequencing may also affect how rare donors are identified and recruited in the future.

Molecular identification of the emerging Human Gemykibivirus-2 (HuGkV-2) among Brazilian blood donors.

Human gemykibivirus-2 (HuGkV-2) belonging to the Gemykibivirus genus (Genomoviridae family) is an emerging DNA virus which has been described as a component of the virome of a wide variety of samples including clinical ones. So far, the HuGkV-2 DNA prevalence in the human population as well as its clinical impact are completely unknown. The objective of this study was to investigate the HuGkV-2 DNA prevalence among Brazilian healthy blood donors from three different geographic regions. A total of 450 blood samples were screened for HuGkV-2 DNA (150 samples were from the Brazilian Amazon, 150 from Midwest Brazil and 150 from South Brazil). The overall HuGkV-2 DNA prevalence was 7.8 %. Considering the examined regions, the highest prevalence was observed in the Brazilian Amazon (city of Macapa, state of Amapa), 15.3 %, followed by the Midwest Brazil (city of Brasilia, Federal District) (6.0 %) and South Brazil (city of Santa Maria, Rio Grande do Sul State) (2.0 %). This study gives preliminary insights on the molecular prevalence of HuGkV-2 DNA among Brazilian blood donors, highlighting that the highest HuGkV-2 prevalence was recorded in the Brazilian Amazon. However, more studies regarding the prevalence, transmission routes and any possible clinical effects appear to be crucial in order to understand the impact of this emerging viral agent.

Medication use in Canadian blood donors.

BACKGROUND AND OBJECTIVES: Policies regarding medication use vary between blood centres. We evaluated medication use in eligible Canadian Blood Services whole blood donors to inform possible process improvements and allow comparisons between donors and the general population. MATERIALS AND METHODS: All donors are asked about medication use in the last 3 days, and medications and their reason for use are documented in our donor computer system. Donor computer records were reviewed from January 1, 2020, to March 31, 2022 to extract information on medications by donor age and sex; medications were grouped into therapeutic classes. Stability of medication use over time was determined in a random sample of 100 donors who made at least two donations in the study period. RESULTS: One-third of successful (eligible) donors were taking medications; of these, 80% were on one or two medications. Five classes of medication accounted for 72% of medication use, and 13 classes account for 93% of use. Use remains relatively stable over time. CONCLUSION: Medication use is common, with a few classes accounting for most use. Drop-down lists and storage of information from one donation to the next may enhance efficiency.

Promoting blood donation through social media: Evidence from Brazil, India and the USA.

Social media has the potential to encourage prosocial behaviors at scale, yet very little causal evidence exists on the impact of related efforts. Blood donation is a particularly difficult, but essential prosocial behavior that is often critically undersupplied. We examine the effect of Facebook's blood donation tool on voluntary blood donation. We partnered with four major blood banks in the United States covering 363 collection facilities in 46 states and Washington, D.C. We tracked the tool's impact on blood donations during its staggered rollout on a sample of more than 47,000 facility-date observations from March 2019 to September 2019. The tool caused an increase of 0.55 total donations per facility per day (+4.0% [95% CI: 0.04%-8.0%]), and an increase of 0.15 donations from first-time donors per facility per day (+18.9% [95% CI: 4.7%-33.1%]). Longitudinal evidence from Brazil and India suggests the share of donors who both received a message from the tool and stated they were influenced by Facebook to donate increased from 0% to 14.1% [95% CI: 12.1%-16.2%] in the first year of the tool's deployment (i.e., September 2018 to August 2019). These meaningful increases, especially from first-time donors, demonstrate that social media platforms can play an important role in fostering offline prosocial behaviors that benefit the health and well-being of societies around the world.

Evolving policies for donors with diabetes: The Canadian experience.

BACKGROUND AND OBJECTIVES: Donor criteria for diabetes vary significantly. We describe our evolving policies for donors with diabetes, their contribution to the Canadian blood supply and their rate of syncopal reactions compared to other donors. MATERIALS AND METHODS: All donors are asked if they have diabetes and have taken medications in the last 3 days. We assessed donors with diabetes on various medications, the number deferred over time, and syncopal reactions in donors with diabetes and other donors in our donor reaction database. RESULTS: Policy changes allowing type 2 diabetic donors on oral hypoglycaemics alone, type 2 diabetic donors on oral medications and insulin and type 1 diabetic donors (all on insulin) to donate resulted in a decrease in deferrals from 450 to 22 donors annually. Of donors being treated with medication for diabetes, 11% are receiving insulin as part of their treatment. Syncopal reaction rates were low and not statistically different between diabetic and non-diabetic donors, although confidence intervals (CIs) are large. CONCLUSION: Policies decreased deferrals while maintaining safety. A longer observation period would strengthen these observations.

Zika virus RNA detection in blood donors in São Paulo, Brazil

ABSTRACT Introduction: The Zika Virus (ZIKV) is a single-stranded RNA genome virus, belonging to the family Flaviviridae, genus Flavivirus. Outbreaks around the world have demonstrated that the presence of asymptomatic viremic blood donors provides an increase in the risk of transfusion transmission (TT) and nucleic acid test (NAT) screening has been proposed to ensure the blood safety. This study implemented an "in-house" method to detect ZIKV RNA in blood sample donations. Methods: Primary plasma tubes are submitted to nucleic acid extraction on an automated platform. After extraction, the NAT set-up is performed in the robotic pipettor, in which an amplification mixture containing primers and probes for ZIKV and Polio vaccine virus (PV) are added in duplex as an internal control. The real-time polymerase chain reaction is then performed in a thermocycler, using the protocol established by the supplier. Results: From May 2016 to May 2018, 3,369 samples were collected from 3,221 blood donors (confidence coefficient 95%), of which 31 were considered false positive (0.92%), as they did not confirm initial reactivity when repeated in duplicates and 14 (0.42%) had their results invalid due to repeat failure in the internal control, 4 (0.12%), due to insufficient sample volume and 2 (0.05%), due to automatic pipettor failures. No Zika RNA reactive sample was identified. Conclusion: The test showed feasible to be incorporated into the blood screening routine. Our data do not indicate the need to screen for ZIKV RNA in São Paulo during the evaluated period. However, a generic NAT system covering a group of flaviviruses which are circulating in the region, such as DENV and YFV, among others, could be a useful tool.

Blood donor candidates and blood donations performed between 2005 and 2019 in Minas Gerais, Brazil: A time series analysis

ABSTRACT Introduction: Time series studies related to blood donor candidates and blood donations are rare in Brazil. Population aging suggests a better understanding of the context related to blood donor candidates and blood donations performed. Objective: The monthly series of candidates eligible to donate blood and actual donations between 2005 and 2019 at the Hemominas Foundation, Minas Gerais, Brazil, were described and analyzed. Methods: Ten time series were constructed of blood donor candidates and blood donations. Each series covered the period from January 2005 to December 2019. The stationarity of the series was verified by the unit root test; the data distribution, by the Shapiro-Wilk test; the trend, by the Cox-Stuart test, and; the seasonality, by the Fisher's test (significance levels of 10% for the first test and 5% for the last three). Results: All series were identified as non-stationary and presented trend and seasonality components. The rate of blood donor candidates and the rate of blood donations performed evidenced a positive upward trend until the last two-year analysis, when a drop occurred, from 1.75% and 1.42% in 2017 to 1.64% and 1.35% in 2019, respectively. The rate of blood donations trended downward, from 0.054% in 2005 to 0.046% in 2019. The proportion of unsuitable or unretained candidates reduced. Conclusion: The study emphasized the need to stimulate blood donation by specific groups and increase ways to reduce the demand for blood components through the implementation of programs that expand alternatives to blood transfusions.

Prevalence of thrombophilia-associated genetic risk factors in blood donors of a regional hospital in southern Brazil

ABSTRACT Introduction: Thromboembolic events occur due to an imbalance in the hemostasis and some factors associated with this condition can be inherited. In order to evaluate the frequency of genotypes considered to be common hereditary risk factors for thrombophilia associated with venous thrombosis (g.1691G>A and g.20210G>A) and hyperhomocysteinemia (g.677C>T and g.1298A>C), samples from voluntary healthy blood donors at the Hospital de Clínicas de Porto Alegre were tested. Methods: We examined 325 blood samples from blood donors collected from October 2017 to July 2018. Blood was collected on filter paper and the DNA was extracted for single nucleotide polymorphisms (SNPs) analysis using the qualitative real time polymerase chain reaction. Results: The calculated frequencies of each genetic variant in heterozygosity were 4% for the FV gene (g.1691G> A), 4% for the F2 gene (g.20210G> A) and 42% and 39% for methylenetetrahydrofolate reductase (MTHFR), g.677C>T and g.1298A>C, respectively. Only the genetic variants of MTHFR were found in homozygosity, with frequencies of 14% and 6% (g.677C>T and g.1298A>C), respectively. Discussion: Altogether, these results describe the frequencies of genetic variants associated with venous thrombosis and hyperhomocysteinemia in the analyzed group and are important to enhance our current knowledge about the genetic profiles of Brazilian blood donors.