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Background: Currently in Australia, men are deferred from donating blood if they have had sex with another man within the past 3  months. However, a proposed gender-neutral assessment (GNA) process will ask all donors questions about sex with new or multiple recent partners, with deferral based on responses to a question about anal sex. Understanding the acceptability of such questions among existing and potential blood donors is paramount for successful implementation of GNA., Study Design and Methods: We used data from a nationally representative survey to estimate the levels of comfort with the proposed GNA questions among the Australian population and subgroups, defined by self-reported ethnicity and religion. Respondents were aged over 18 and living in Australia. Results were weighted to represent the population., Results: Most of the 5178 respondents described themselves as comfortable with answering questions about new partners (73.1%) or anal sex (64.0%) to donate blood. However, 2.2% and 4.5% indicated that questions about new sex partners and anal sex, respectively, would stop them from donating, and 4.4% and 7.7% respectively, said they were "completely uncomfortable." By religion, the least comfortable were Muslim or Eastern Orthodox respondents, and by country of birth, the least comfortable were those born in the Middle East, followed by those born in Southern Europe and Asia., Discussion: GNA appears to be broadly acceptable in the Australian context, but our findings suggest that key GNA questions are less acceptable in some population subgroups, indicating a need for targeted campaigns that consider cultural sensitivities., (© 2024 The Author(s). Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Passive immunisation with normal human immunoglobulin (NHIG) is recommended as post-exposure prophylaxis (PEP) for higher-risk measles contacts where vaccination is contraindicated. However, the concentration of measles-specific antibodies in NHIG depends on antibody levels within pooled donor plasma. There are concerns that measles immunity in the Australian population may be declining over time and that blood donors' levels will progressively decrease, impacting levels required to produce effective NHIG for measles PEP. A cross-sectional study of Australian plasmapheresis donors was performed using an age-stratified, random sample of recovered serum specimens, collected between October and November 2019 ( n = 1199). Measles-specific IgG antibodies were quantified by ELISA (Enzygnost anti-measles virus IgG, Siemens), and negative and equivocal specimens ( n = 149) also underwent plaque reduction neutralisation testing (PRNT). Mean antibody levels (optical density values) progressively decreased from older to younger birth cohorts, from 2.09 [±0.09, 95% CI] to 0.58 [±0.04, 95% CI] in donors born in 1940-1959 and 1990-2001, respectively ( p < 0.0001). This study shows that mean measles-specific IgG levels are significantly lower in younger Australian donors. While current NHIG selection policies target older donors, as younger birth cohorts become an increasingly larger proportion of contributing donors, measles-specific antibody concentrations of NHIG will progressively reduce. We therefore recommend monitoring measles-specific antibody levels in future donors and NHIG products in Australia and other countries that eliminated measles before the birth of their youngest blood donors.

Background: In Australia, a man cannot donate blood if he has had sex with another man within the past 3 months. However, this policy has been criticized as being discriminatory as it does not consider lower risk subgroups, and led to calls for modifications to the policy that more accurately distinguish risk among gay, bisexual, and other men who have sex with men (GBM)., Study Design and Methods: We used data from a nationally representative survey to estimate the proportion of GBM aged 18-74 years old who would be eligible to donate under current criteria and other scenarios., Results: Among the 5178 survey participants, 155 (3.0%) were classified as GBM based on survey responses, Among the GBM, 40.2% (95% CI 28.0%-53.7%) were eligible to donate based on current criteria, and 21.0% (95% CI 14.5%-29.5%) were ineligible due to the 3 months deferral alone. Eligibility among GBM, all men, and the population increased as criteria were removed. Under the new Australian plasma donation criteria, 73.6% (95% CI 64.4%-81.1%) of GBM, 68.4% (95% CI 65.5%-71.2%) of all men, and 60.8% (95% CI 58.8%-62.8%) of the full population were estimated to be eligible. Only 16.1% (95% CI 8.6%-28.1%) of GBM knew that the male-to-male sex deferral period is 3 months., Discussion: Changing the deferral criteria and sexual risk evaluation would lead to a higher proportion of GBM being eligible to donate blood. Knowledge of the current GBM deferral period is very low. Improved education about the current criteria and any future changes are required to improve blood donation rates., (© 2024 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Introduction: Japanese encephalitis virus (JEV) is a mosquito-borne flavivirus that causes encephalitis and other morbidity in Southeast Asia. Since February 2022, geographically dispersed JEV human, animal and vector detections occurred on the Australian mainland for the first time. This study will determine the prevalence of JEV-specific antibodies in human blood with a focus on populations at high risk of JEV exposure and determine risk factors associated with JEV seropositivity by location, age, occupation and other factors., Method: Samples are collected using two approaches: from routine blood donors (4153 samples), and active collections targeting high-risk populations (convenience sampling). Consent-based sampling for the latter includes a participant questionnaire on demographic, vaccination and exposure data. Samples are tested for JEV-specific total antibody using a defined epitope-blocking ELISA, and total antibody to Australian endemic flaviviruses Murray Valley encephalitis and Kunjin viruses., Analysis: Two analytic approaches will occur: descriptive estimates of seroprevalence and multivariable logistic regression using Bayesian hierarchical models. Descriptive analyses will include unadjusted analysis of raw data with exclusions for JEV-endemic country of birth, travel to JEV-endemic countries, prior JEV-vaccination, and sex-standardised and age-standardised analyses. Multivariable logistic regression will determine which risk factors are associated with JEV seropositivity likely due to recent transmission within Australia and the relative contribution of each factor when accounting for effects within the model., Ethics: National Mutual Acceptance ethical approval was obtained from the Sydney Children's Hospitals Network Human Research Ethics Committee (HREC). Local approvals were sought in each jurisdiction. Ethical approval was also obtained from the Australian Red Cross Lifeblood HREC., Dissemination: Findings will be communicated to participants and their communities, and human and animal health stakeholders and policy-makers iteratively and after final analyses. Understanding human infection rates will inform procurement and targeted allocation of limited JEV vaccine, and public health strategies and communication campaigns, to at-risk populations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Reliable estimates of the population proportion eligible to donate blood are needed by blood collection agencies to model the likely impact of changes in eligibility criteria and inform targeted population-level education, recruitment, and retention strategies. In Australia, the sole estimate was calculated 10+ years ago. With several subsequent changes to the eligibility criteria, an updated estimate is required., Study Design and Methods: We conducted a cross-sectional national population survey to estimate eligibility for blood donation. Respondents were aged 18+ and resident in Australia. Results were weighted to obtain a representative sample of the population., Results: Estimated population prevalence of blood donation eligibility for those aged 18-74 was 57.3% (95% CI 55.3-59.3). The remaining 42.7% (95% CI 40.7-44.7) were either temporarily (25.3%, 95% CI 23.5-27.2) or permanently ineligible (17.4%, 95% CI 16.1-18.9). Of those eligible at the time of the survey, that is, with the UK geographic deferral for variant Creutzfeldt-Jakob disease included, (52.9%, 95% CI 50.8-54.9), 14.2% (95% CI 12.3-16.3) reported donating blood within the previous 2 years. Eligibility was higher among men (62.6%, 95% CI 59.6-65.6) than women (52.8%, 95% CI 50.1-55.6). The most common exclusion factor was iron deficiency/anemia within the last 6 months; 3.8% (95% CI 3.2-4.6) of the sample were ineligible due to this factor alone., Discussion: We estimate that approximately 10.5 million people (57.3% of 18-74-year-olds) are eligible to donate blood in Australia. Only 14.2% of those eligible at the time of survey reported donating blood within the previous 2 years, indicating a large untapped pool of potentially eligible blood donors., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)

Aim: Australian Red Cross Lifeblood supplies pasteurised donor human milk (PDHM) to more than 30 partner hospitals across Australia. Preterm infants who receive PDHM are a highly vulnerable population but formal biovigilance programs are rare in human milk banking. Lifeblood Milk performs ongoing surveillance for both donor and recipient adverse events. This study aimed to formally review adverse events reported to Lifeblood Milk since 2018., Methods: Milk donor infectious diseases testing outcomes and donor adverse events (DAEs) are prospectively recorded at Lifeblood. Infant recipient adverse events are contractually reported back to Lifeblood Milk by hospitals and assessed according to severity and likelihood of relationship to PDHM administration. Donor and recipient adverse events over a 3.5-year period (July 2018 to December 2021) were reviewed., Results: There were three DAEs (3/976 = 0.31%) related to phlebotomy; these included two vasovagal reactions and one phlebotomy site haematoma. Eight (8/976 = 0.81%) additional donors had biological false reactive (BFR) infectious diseases serology results. There were 10 reported suspected adverse events in recipients. Six were infection-related; other events included milk curd obstruction, high urinary iodine levels, sudden cardiac death and nasogastric tube obstruction. All reported suspected adverse events in recipients were classified as unlikely to be related, or definitely not related, to PDHM administration., Conclusions: Milk donor adverse events were rare but biological false reactive serology results were not uncommon. There were no recipient adverse events considered causally related to pasteurised donor human milk, which is generally a low-risk biological product. Ongoing biovigilance remains essential., (© 2022 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Background: Several studies have described associations between ABO blood group and SARS-CoV-2 infection severity in hospitalized patients where group A individuals are over-represented and group O individuals may have a lower infection rate. In convalescent individuals, group B blood donors have higher neutralizing SARS-CoV-2 antibody titers. We analyzed whether there was any correlation of ABO Rh(D) blood group with SARS-CoV-2 infection and with neutralizing antibodies in Australian convalescent plasma (CP) donors., Study Design and Methods: ABO Rh(D) distribution and demographics of CP donors (n = 765) were compared with the total blood donor panel (n = 488,028), plasmapheresis donors (n = 203,176) and whole blood donors (n = 282,437) from 2020. The presence of neutralizing antibodies in CP donors was measured using the Vero E6 cell microneutralization assay., Results: The distribution of ABO group in CP donors compared to the total donor panel was not significantly different (p = .177). There were significantly more group AB donors in the plasmapheresis subset (p = .005) and group O individuals were over-represented in the whole blood donor subset (p < .0001). There was no significant difference in neutralizing antibody levels among CP donors with differing ABO blood groups (p = .872)., Conclusion: ABO Rh(D) blood group distribution was not found to be significantly different between convalescent plasma donors and general blood donors in our large sample group. Inherent blood donor selection biases associated with clinical demand accounted for some differences within CP donors. The levels of SARS-CoV-2 neutralizing antibodies were also not significantly associated with ABO Rh(D) group., (© 2021 AABB.)

Objectives: To determine the motivators and barriers to COVID-19 convalescent plasma donation by those in the United Kingdom who have been diagnosed with or who have had symptoms of SARS-CoV-2 (COVID-19) but who have not donated., Background: Convalescent plasma from people recovered from COVID-19 with sufficient antibody titres is a potential option for the treatment and prevention of COVID-19. However, to date, recruiting and retaining COVID-19 convalescent plasma donors has been challenging. Understanding why those eligible to donate COVID-19 convalescent plasma have not donated is critical to developing recruitment campaigns., Methods/materials: A total of 419 UK residents who indicated that they had been infected with COVID-19 and who lived within 50 km of sites collecting COVID-19 convalescent plasma completed an online survey between 25th June and 5th July 2020. Respondents completed items assessing their awareness of convalescent plasma, motivations and barriers to donation and intention to donate COVID-19 convalescent plasma., Results: Awareness of COVID-19 convalescent plasma was low. Exploratory factor analysis identified six motivations and seven barriers to donating. A stronger sense of altruism through adversity and moral and civic duty were positively related to intention to donate, whereas generic donation fears was negatively related., Conclusions: Once potential donors are aware of convalescent plasma, interventions should focus on the gratitude and reciprocity that those eligible to donate feel, along with a focus on (potentially) helping family and norms of what people ought to do. Fears associated with donation should not be neglected, and strategies that have been successfully used tor recruit whole-blood donors should be adapted and deployed to recruit COVID-19 convalescent plasma donors., (© 2020 British Blood Transfusion Society.)

Background and Objectives: In 2018, Australian Red Cross Lifeblood changed its plasmapheresis eligibility criteria to allow donors to donate plasma without the requirement of a prior successful whole blood donation. This study evaluated the impact of this policy change on donor retention and donor safety., Materials and Methods: All donors who had attempted to give their first plasma or whole blood donation from January to June 2018 were included in this retrospective cohort study. Donor characteristics and adverse events were analysed for this index donation, and the cohort was followed for 18 months to analyse time to return, subsequent donation frequency and predictors of return., Results: Male and younger donors provided a significantly greater proportion of first donation plasma than females and older donors. New donors who gave plasma had the highest rate of donor adverse events, including vasovagal reactions and phlebotomy injuries. Nevertheless, donor retention was not affected, with more new donors returning and at a greater subsequent donation frequency after a plasma donation compared to new donors donating whole blood. First-time plasma donors who had previously donated whole blood, however, had greater and quicker rates of return, and more subsequent donations., Conclusion: Offering new donors the option to give plasma had a positive effect on donor return and subsequent donation frequency. Removing the requirement of a prior whole blood donation is a viable way to increase plasma collections although the combined effect of new donor status and plasmapheresis procedure on adverse event risk needs to be considered., (© 2020 International Society of Blood Transfusion.)

Background: Definitive criteria for microbial screening of pasteurized donor human milk are not well established and international recommendations vary., Aims: (1) To review pasteurized donor human milk batch discard due to failed microbial screening criteria at our milk bank (following United Kingdom National Institute of Clinical Excellence guidelines), and (2) to compare our known milk discard proportion with estimated milk discard proportions that would be required by other international milk bank guidelines., Methods: We reviewed our microbial screening results ( N = 783) over 18-months (July 2018-December 2019) and compared our known milk discard proportion with estimated milk discard proportions using other international milk bank guidelines., Results: Of samples, n = 50 (6.4%) failed pre-pasteurization screening, most commonly due to the presence of >10 4 CFU/mL Enterobacterales in the pre-pasteurization sample ( n = 30; 3.8%). Two (0.3%) samples failed post-pasteurization screening, with Bacillus cereus identified in both cases, resulting in total discard proportion of 6.7% ( n = 52) of batches. Applying European Milk Bank Association recommended bacterial screening criteria, approximately 23.3% ( n = 183) of milk batches would have been discarded., Conclusions: Further research is required to justify the stringent European Milk Bank Association recommendations for pre-pasteurization discard criteria, although we believe that a post-pasteurization acceptance criterion of <1 CFU/mL is appropriate and aligns with international guidance. Further work is needed to understand pasteurized donor human milk microbiological safety risks, to better integrate screening criteria within current food standards regulation, and to consider risk-based assessment including the impact on availability and affordability.

Aim: Donor selection for milk banks is essential to ensure the safety and nutritional quality of the donor milk, and to ensure that the prospective donor and her breastfeeding infant do not come to harm through donating. Australian Red Cross Lifeblood Milk went through a robust process to develop a set of criteria for the selection and screening of potential breast milk donors, which included development of a Donor Questionnaire (DQ), supported by a formal set of Guidelines for the Selection of Milk Donors. Key screening questions from the DQ were made available to prospective donors to self-screen prior to the formal assessment process. The aim of this study was to review the outcomes of milk donor screening at Lifeblood Milk., Methods: We reviewed the outcomes of our donor screening process over the first 12-months (July 2018-June 2019) of operations., Results: A total of 50 out of 327 donors who responded to the self-screening questions were not able to proceed further; 201 donors were formally screened using the DQ and Guidelines for the Selection of Milk Donors, with 9 of 201 deferred based on their responses. An additional two donors were deferred (failed phlebotomy (n = 1) and reactive infectious disease serology (n = 1)), with 190 of 201 (95%) of prospective donors accepted after screening., Conclusions: Our experience highlighted international differences in practice between milk banks and lack of strong research to inform milk donor selection. Making a set of key screening questions available to donors for self-screening resulted in a high acceptance rate (95%) for donors who began the formal screening process. Further work is needed to better understand the impact of deferral on prospective milk donors., (© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Background: Men who have sex with men in Australia are currently ineligible to donate blood (are "deferred") for 12 months since last oral or anal sexual contact with another man. In Australia and overseas, there has been limited research on attitudes and perceptions related to blood donation in this population., Study Design and Methods: Questions on blood donation histories and attitudes toward the deferral policy were included in the questionnaire of an online prospective cohort of gay and bisexual men (GBM) living in Australia., Results: In 2018, 1595 GBM responded to the survey. In this sample, 28.7% reported previously donating blood. Among the remaining men who had never donated blood, 64.5% expressed an interest in doing so. Nearly all men indicated they were not willing to abstain from sex with another man for 12 months in order to donate, and the vast majority believed the rule was unfair, too strict, and homophobic. Three-quarters (77.7%) said that if the policy changed, they would likely donate blood. Age and openness about one's sexuality were independently associated with one's willingness to donate blood in the absence of the deferral., Conclusion: There was a high level of willingness and desire to donate blood among GBM. However, rather than abstaining from sex in order to donate, many men comply with the deferral policy and do not donate. A less conservative deferral policy may increase donations from GBM., (© 2020 AABB.)

Background and Objectives: Until recently, people in Australia with a history of injection drug use (IDU) were deferred indefinitely from donating blood. Knowledge gaps regarding policy non-compliance and the prevalence of blood donation practices amongst people who inject drugs (PWID) precluded changes to this policy. We sought to address these gaps and to estimate the additional risk to Australia's blood supply associated with changing the indefinite deferral policy to 1 or 5 years since last injecting episode., Materials and Methods: Data on blood donation amongst PWID were collected from 1853 interviews across two Australian studies of PWID conducted during 2015/16. Mathematical modelling was used to estimate the additional risk of hepatitis C (HCV)-infected window period collections as a result of changing the deferral policy., Results: A very few (2-4%) study participants reported ever donating blood after ≥1 IDU episode. Changing the deferral policy from indefinite to 1 or 5 years was estimated to result in an additional 0·00000070 (95%CI: 0·00000033-0·00000165) or 0·00000020 (95%CI: 0·00000008-0·00000041) HCV-positive window period collections per year, respectively., Conclusion: Changing Australia's indefinite deferral period to 1 or 5 years since last injecting episode poses a negligible increase in the risk of HCV-infected window period collections from blood donors with a history of IDU. Our results informed a successful submission to the Australian regulator to change the deferral period from indefinite to 5 years since last injecting episode, a policy which came into effect in September 2018., (© 2020 International Society of Blood Transfusion.)

Background and Objectives: Donor syphilis testing began in the 1940s amidst widespread transfusion-transmitted syphilis (TTS). Since then, the introduction of penicillin, pre-donation screening questionnaires and improved storage conditions have contributed to reducing transmission risk. Consequently, universal testing may no longer be cost-effective. This study analysed alternative options for donor syphilis testing to determine the optimal strategy., Materials and Methods: A model was developed using conservative parameter estimates for factors affecting TTS and 2009-2015 Australian donations to calculate risk outcomes (TTS infections, tertiary syphilis in recipients and transfusion-associated congenital syphilis) and cost-effectiveness of alternative testing strategies. The strategies modelled were as follows: universal testing, targeted-testing of high-risk groups (males ≤50 years old and first-time donors) and no testing., Results: The estimated risk of TTS is one in 49·5 million transfusions for universal testing, one in 6 million for targeted-testing of males ≤50 years old, one in 4 million for targeted-testing of first-time donors and one in 2·8 million for no testing. For all strategies, the risk of tertiary and congenital syphilis is <1 in 100 million. Universal testing is the least cost-effective strategy with an incremental cost-effectiveness ratio (ICER) estimated at $538·5 million per disability-adjusted life year averted., Conclusion: Universal testing is not required to maintain the risk of TTS within tolerable limits and is estimated to greatly exceed acceptable ICERs for blood safety interventions. However, despite a strong economic and risk-based rationale, given the epidemiology of syphilis in Australia is changing, feedback from critical stakeholders is not currently supportive of reducing testing., (© 2018 International Society of Blood Transfusion.)

Background: In many developed countries hepatitis E virus (HEV) infections have occurred predominantly in travellers to countries endemic for HEV. HEV is a potential threat to blood safety as the virus is transfusion-transmissible. To minimise this risk in Australia, individuals diagnosed with HEV are deferred. Malarialdeferrals, when donors are restricted from donating fresh blood components following travel toanareain which malaria is endemic, probably also decrease the HEV risk, by deferring donors who travel to many countries also endemic for HEV. The aim of this study is to describe overseas-acquired HEV cases in Australia, in order to determine whether infection in travellers poses a risk to Australian blood safety., Materials and Methods: Details of all notified HEV cases in Australia from 2002 to 2014 were accessed, and importation rates estimated. Countries in which HEV was acquired were compared to those for which donations are restricted following travel because of a malaria risk., Results: Three hundred and thirty-two cases of HEV were acquired overseas. Travel to India accounted for most of these infections, although the importation rate was highest for Nepal and Bangladesh. Countries for which donations are restricted following travel due to malaria risk accounted for 94% of overseas-acquired HEV cases., Discussion: The vast majority of overseas-acquired HEV infections were in travellers returning from South Asian countries, which are subject to donation-related travel restrictions for malaria. This minimises the risk HEV poses to the Australian blood supply.

Background: It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors., Study Design and Methods: This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors., Results: Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts., Conclusions: The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile., (© 2016 AABB.)

Background: Hepatitis E virus (HEV) poses a risk to transfusion safety. In Australia, locally acquired HEV is rare and cases are mainly reported in travelers returning from countries endemic for HEV. The risk posed by HEV to transfusion safety in Australia is unknown; therefore, we aimed to measure the rate of current HEV infection in Australian blood donations., Study Design and Methods: A total of 14,799 blood donations were tested for HEV RNA by transcription-mediated amplification, with confirmatory testing by reverse transcription-polymerase chain reaction. Viral load quantification and phylogenetic analysis was performed on HEV RNA-positive samples., Results: One (0.0068%; 95% confidence interval [CI], 0.0002%-0.0376%) sample was confirmed positive for HEV RNA, resulting in a risk of collecting a HEV-viremic donation of 1 in 14,799 (95% CI, 1 in 584,530 to 1 in 2,657). The viral load in this sample was approximately 15,000 IU/mL, and it was determined to be Genotype 3., Discussion: Our finding of 1 in 14,799 Australian donations positive for HEV RNA is lower than that from many other developed countries; this is consistent with the relatively low seroprevalence in Australia. As this HEV RNA-positive sample was Genotype 3, it seems likely that this infection was acquired through zoonotic transmission, either within Australia or overseas in a developed nation. HEV has the potential to pose a risk to transfusion safety in Australia; however, additional, larger studies are required to quantify the magnitude of this risk., (© 2016 AABB.)