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1.
Transfusion ; 64(10): 1940-1948, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39189045

RESUMEN

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.


Asunto(s)
Donantes de Sangre , Conducta Sexual , Humanos , Donantes de Sangre/psicología , Donantes de Sangre/estadística & datos numéricos , Masculino , Adulto , Australia , Femenino , Persona de Mediana Edad , Medición de Riesgo , Encuestas y Cuestionarios , Adolescente , Parejas Sexuales/psicología , Adulto Joven , Anciano , Donación de Sangre
2.
Transfusion ; 64(3): 493-500, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38348786

RESUMEN

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.


Asunto(s)
Infecciones por VIH , Minorías Sexuales y de Género , Masculino , Humanos , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Homosexualidad Masculina , Donación de Sangre , Donantes de Sangre , Australia , Conducta Sexual , Asunción de Riesgos
3.
Vox Sang ; 119(2): 94-101, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37641582

RESUMEN

Many blood establishments are expanding plasmapheresis collection capacity to achieve increasing plasma for fractionation volume targets, driven by immunoglobulin product demand. Some adverse events occur in both apheresis and whole blood collection, such as venepuncture-related trauma and vasovagal reactions. Others are specifically related to the apheresis procedure, such as citrate reactions, haemolysis, infiltration and air embolism. Whilst plasmapheresis procedures are generally well tolerated, theoretical longer term donor health considerations, such as the effects on donor plasma protein levels, bone mineral density, iron deficiency and malignancy also require consideration. An evidence-based framework that supports a safe and sustainable increase in the collection of plasma is essential. Our review demonstrates a lack of high-quality evidence on risks and outcomes specifically in plasmapheresis. Whilst conservative procedural controls and donor harm minimization policies will mitigate risk, high-quality evidence is needed to facilitate practice change that is safe and sustainable and maximizes the potential of individual donor differences.


Asunto(s)
Eliminación de Componentes Sanguíneos , Plasmaféresis , Humanos , Plasmaféresis/efectos adversos , Eliminación de Componentes Sanguíneos/efectos adversos , Donantes de Sangre , Flebotomía , Plasma
4.
Vox Sang ; 119(9): 945-952, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39048116

RESUMEN

BACKGROUND AND OBJECTIVES: To reduce the risk of transfusion-transmitted malaria (TTM) from transfusible components, Australia tests for malaria antibodies in both travellers returning from and former residents of malaria-endemic areas. The testing is performed a minimum of 120 days after last potential exposure. TTM is an extremely rare event and managing the risk adds considerable complexity. The objectives of this study were to analyse various testing and deferral strategies, considering the risk, donation numbers and operational complexities. MATERIALS AND METHODS: A residual risk model was developed to calculate the risk of TTM in five testing/deferral strategies. Australian blood donor data from 2020 and 2021 were used and incorporated the incidence of parasitaemia, Plasmodium species and the malaria enzyme immunoassay test's failure rate. Donor and donation loss or gain and an operational assessment were performed. RESULTS: The current model's estimated risk of TTM is 1 in 67.9 million transfused units. Testing residents with a 120-day plasma restriction for visitors without testing was found to have the same estimated risk, with an expected increase of 342 donations per year, significant cost savings and a 62% reduction in the number of donors requiring assessment. CONCLUSION: A strategy that involves testing residents of malaria areas only and a 120-day plasma travel restriction would not significantly increase the risk of TTM, is operationally simpler, costs less and results in a small increase in donations.


Asunto(s)
Donantes de Sangre , Malaria , Reacción a la Transfusión , Humanos , Australia/epidemiología , Malaria/transmisión , Malaria/prevención & control , Malaria/epidemiología , Malaria/sangre , Reacción a la Transfusión/epidemiología , Reacción a la Transfusión/prevención & control , Selección de Donante/métodos , Transfusión Sanguínea , Viaje , Femenino , Donación de Sangre
5.
Vox Sang ; 119(9): 927-935, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38925639

RESUMEN

BACKGROUND AND OBJECTIVES: Tattooing is one of the leading donor deferral reasons in Australia. Until September 2020, donors were deferred from all donation types for 4 months after a tattoo. At this time, our guideline changed such that donations of plasma for further manufacture were accepted immediately, provided the tattoo was administered in a licensed or regulated Australian establishment. We examined the effects of this change. MATERIALS AND METHODS: Donors with a tattoo deferral in the 2 years before or after the guideline change were identified and followed up until 3 November 2022. Between the two periods, we compared blood-borne virus (BBV) incidence, donor return, and the number of donors and donations regained after deferral. RESULTS: The incidence of BBV infection in donors after a tattoo deferral was zero in both periods. To exceed a residual risk of 1 in 1 million for hepatitis C virus, 190 donors would need to be infected yearly from a tattoo. Donors returned to donate significantly faster after the change (median return 85 days compared with 278 days). An extra 187 donations per 10,000 person-years of observation were gained, yielding a total of 44,674 additional plasma donations nationally 0-4 months after getting a tattoo. CONCLUSION: Allowing plasma donations immediately post-tattoo resulted in a substantial donation gain with no adverse safety effect. Lifeblood subsequently reduced the deferral for transfusible component donations to 7 days for tattoos in Australian licensed/regulated establishments.


Asunto(s)
Donantes de Sangre , Plasmaféresis , Tatuaje , Humanos , Australia/epidemiología , Masculino , Femenino , Infecciones de Transmisión Sanguínea/prevención & control , Infecciones de Transmisión Sanguínea/epidemiología , Adulto , Seguridad de la Sangre , Incidencia
6.
Vox Sang ; 119(9): 936-944, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39048114

RESUMEN

BACKGROUND AND OBJECTIVES: The risk of transfusion-transmitted malaria (TTM) infections is extremely low in Australia, and the cost-effectiveness of the current screening strategy has not been assessed. This study aims to conduct a cost-effectiveness analysis of different malaria screening strategies in blood donors as part of the risk-based decision-making framework. MATERIALS AND METHODS: A decision tree model was developed to assess the cost-effectiveness of five alternative malaria screening strategies from a healthcare sector perspective. Screening strategies combining total or partial removal of malaria testing with different deferral periods were considered. The probabilities of developing severe and uncomplicated TTM were based on a literature review of cases in non-endemic areas since 2000. The health outcomes were quantified using disability-adjusted life years. The costs of non-returning donors due to deferral were also included. Deterministic and probabilistic sensitivity analyses were conducted to account for data uncertainty. RESULTS: The residual risks for all strategies were so low that the costs, mortality and morbidity associated with TTM are almost negligible. The overall costs were predominantly influenced by the costs of non-returning blood donors. As a result, removal of malaria testing and applying a 28-day deferral for at-risk donors were the least costly and most cost-effective of all the options considered. CONCLUSION: The current screening strategy for malaria in blood donors in Australia is not an efficient use of healthcare resources. Partial or total removal of malaria testing would bring significant cost savings without significantly compromising blood safety.


Asunto(s)
Donantes de Sangre , Análisis Costo-Beneficio , Malaria , Humanos , Australia , Malaria/diagnóstico , Malaria/economía , Malaria/sangre , Árboles de Decisión , Selección de Donante/economía , Selección de Donante/métodos , Tamizaje Masivo/economía , Tamizaje Masivo/métodos , Femenino , Masculino , Análisis de Costo-Efectividad
7.
Vox Sang ; 119(6): 619-623, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38451394

RESUMEN

BACKGROUND AND OBJECTIVES: Until 25 July 2022, Australians who had spent more than 6 months in the United Kingdom or territories between 1980 and 1996 were deferred from blood donation due to the risk of variant Creutzfeldt-Jakob disease. Removal of this geography-based donor deferral on RhD-negative blood availability has not been reported. MATERIALS AND METHODS: All donors who donated at least once from 25 July 2022 to 25 July 2023 were included. UK donor status, first-time donor and ABO RhD data were extracted from the National Blood Management System. RESULTS: Data from 566,447 blood donors with a valid ABO RhD result were analysed. Of these, 34,560 were new or returning lapsed donors following removal of the UK donor deferral. The median age [range] in years for all donors was 43 [75] with UK donors being older 53 [70]. There was a higher prevalence of RhD-negative status in UK donors (20.2%) compared with first-time blood donors (15.7%). CONCLUSION: UK donors were generally older, female and more likely to be RhD-negative. Although UK donors provided a boost to RhD-negative blood collections, the overall prevalence of ABO RhD blood groups in the total Australian blood donor panel remained similar to previous estimates.


Asunto(s)
Sistema del Grupo Sanguíneo ABO , Donantes de Sangre , Síndrome de Creutzfeldt-Jakob , Sistema del Grupo Sanguíneo Rh-Hr , Humanos , Femenino , Australia/epidemiología , Síndrome de Creutzfeldt-Jakob/sangre , Síndrome de Creutzfeldt-Jakob/epidemiología , Masculino , Persona de Mediana Edad , Adulto , Anciano , Reino Unido/epidemiología , Selección de Donante
8.
Transfusion ; 63(8): 1528-1537, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37300281

RESUMEN

BACKGROUND: In Australia, men who have sex with men (MSM) are deferred from blood donation for 3 months from last sexual contact. Internationally, deferral policies for MSM are evolving in the direction of expanded inclusivity in response to community expectations. To inform future policy options, we assessed perceptions of the risk of HIV transmission from blood transfusion among Australian MSM. STUDY DESIGN AND METHODS: Flux is an online prospective cohort of Australian gay and bisexual men (cis or trans, regardless of their sexual history) and other men who have had sex with men (gbMSM). We included questions on blood donation rules, window period (WP) duration, infectivity of blood from people with HIV on treatment and attitudes to more detailed questioning of sexual practices in the regular survey of Flux participants and conducted a descriptive analysis of responses. RESULTS: Of 716 Flux participants in 2019, 703 responded to the blood donation questions. The mean age was 43.7 years (SD 13.6 years). Overall, 74% were willing to confidentially respond to specific sexual behavior questions, such as the last time they had sex and the type of sex they had, in order to be considered eligible to donate blood. The majority (92%) of participants correctly assessed the duration of the WP as less than 1 month. When asked whether transfusion of blood from a donor with HIV and an undetectable viral load could transmit HIV, just under half (48%) correctly said yes. CONCLUSION: Our study suggests Australian gbMSM are generally comfortable with answering more detailed questions regarding sexual activity during the assessment to donate, indicating they would do so honestly. gbMSM are knowledgeable about the WP duration, important for their ability to correctly self-assess their HIV risk. However, half of participants incorrectly assessed the transmissibility by blood transfusion from an HIV positive person with an undetectable viral load, suggesting the need for a targeted education campaign.


Asunto(s)
Infecciones por VIH , Minorías Sexuales y de Género , Masculino , Humanos , Adulto , Homosexualidad Masculina , Infecciones por VIH/epidemiología , Estudios Prospectivos , Australia/epidemiología , Conducta Sexual , Transfusión Sanguínea
9.
Transfusion ; 63(8): 1519-1527, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37464879

RESUMEN

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.


Asunto(s)
Donación de Sangre , Donantes de Sangre , Masculino , Humanos , Femenino , Estudios Transversales , Prevalencia , Australia/epidemiología
10.
Vox Sang ; 118(6): 480-487, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37183505

RESUMEN

BACKGROUND AND OBJECTIVES: Parallel testing of blood donations for hepatitis C virus (HCV) antibody and HCV RNA by nucleic acid testing (NAT) has been standard practice in Australia since 2000. Meanwhile, NAT technologies have improved, and HCV has become a curable disease. This has resulted in a significant reduction in the risk and clinical consequences of HCV transmission through transfusion. This study aimed to estimate the residual risk (RR) under various testing options to determine the optimal testing strategy. MATERIALS AND METHODS: A developed deterministic model calculated the RR of HCV transmission for four testing strategies. A low, mid and high estimate of the RR was calculated for each. The testing strategies modelled were as follows: universal dual testing, targeted dual testing for higher risk groups (first-time donors or transfusible component donations) and universal NAT only. RESULTS: The mid estimate of the RR was 1 in 151 million for universal dual testing, 1 in 111 million for targeted dual testing of first-time donors, 1 in 151 million for targeted dual testing for transfusible component donations and 1 in 66 million for universal NAT only. For all testing strategies, all estimates were considerably less than 1 in 1 million. CONCLUSION: Antibody testing in addition to NAT does not materially change the risk profile. Even conservative estimates for the cessation of anti-HCV predict an HCV transmission risk substantially below 1 in 1 million. Therefore, given that it is not contributing to blood safety in Australia but consuming resources, anti-HCV testing can safely be discontinued.


Asunto(s)
Donación de Sangre , Hepatitis C , Humanos , Australia/epidemiología , Donantes de Sangre , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Técnicas de Amplificación de Ácido Nucleico
11.
Vox Sang ; 118(10): 891-894, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37563946

RESUMEN

BACKGROUND AND OBJECTIVES: Until 25 July 2022, people who spent more than 6 months in the United Kingdom during the variant Creutzfeldt-Jakob disease (vCJD) risk period 1980-1996 (UK donors) were deferred from blood donation in Australia. Regulatory approval to remove the deferral was underpinned by published mathematical modelling predicting negligible vCJD transmission risk increase with a gain of 58,000 donations. MATERIALS AND METHODS: The donor questionnaire retained the UK deferral screening question until a version update effective 12 February 2023, which enabled identification of the newly eligible cohort of UK donors. Their donations were tracked for a 6-month period (25 July 2022-24 January 2023) and compared with baseline Lifeblood donation metrics and predicted gains. RESULTS: A total of 38,462 UK donors attended to donate 78,762 times in the 6 months. Of these, 32,358 donors (females = 19,456, males = 12,902) successfully donated 67,914 times representing 8.4% of total collections. CONCLUSION: Cessation of the UK deferral resulted in donation gains exceeding modelled predictions because of a higher than predicted number of donors who donated at a higher rate. Had these newly eligible donors not donated, overall donation numbers would have been 88% of target rather than the 96% achieved.


Asunto(s)
Síndrome de Creutzfeldt-Jakob , Masculino , Femenino , Humanos , Donantes de Sangre , Donación de Sangre , Australia , Reino Unido
12.
Vox Sang ; 118(6): 471-479, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37183482

RESUMEN

BACKGROUND AND OBJECTIVES: The risk of transfusion-transmitted hepatitis C virus (HCV) infections is extremely low in Australia. This study aims to conduct a cost-effectiveness analysis of different testing strategies for HCV infection in blood donations. MATERIALS AND METHODS: The four testing strategies evaluated in this study were universal testing with both HCV antibody (anti-HCV) and nucleic acid testing (NAT); anti-HCV and NAT for first-time donations and NAT only for repeat donations; anti-HCV and NAT for transfusible component donations and NAT only for plasma for further manufacture; and universal testing with NAT only. A decision-analytical model was developed to assess the cost-effectiveness of alternative HCV testing strategies. Sensitivity analysis and threshold analysis were conducted to account for data uncertainty. RESULTS: The number of potential transfusion-transmitted cases of acute hepatitis C and chronic hepatitis C was approximately zero in all four strategies. Universal testing with NAT only was the most cost-effective strategy due to the lowest testing cost. The threshold analysis showed that for the current practice to be cost-effective, the residual risks of other testing strategies would have to be at least 1 HCV infection in 2424 donations, which is over 60,000 times the baseline residual risk (1 in 151 million donations). CONCLUSION: The screening strategy for HCV in blood donations currently implemented in Australia is not cost-effective compared with targeted testing or universal testing with NAT only. Partial or total removal of anti-HCV testing would bring significant cost savings without compromising blood recipient safety.


Asunto(s)
Donación de Sangre , Hepatitis C , Humanos , Australia , Donantes de Sangre , Análisis de Costo-Efectividad , Hepatitis C/diagnóstico , Técnicas de Amplificación de Ácido Nucleico
13.
Transfusion ; 62(2): 292-297, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34936102

RESUMEN

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.


Asunto(s)
Sistema del Grupo Sanguíneo ABO , Anticuerpos Neutralizantes/sangre , Anticuerpos Antivirales/sangre , Donantes de Sangre , COVID-19 , Animales , Australia , COVID-19/terapia , Chlorocebus aethiops , Humanos , Inmunización Pasiva , Pruebas de Neutralización , SARS-CoV-2/inmunología , Células Vero , Sueroterapia para COVID-19
14.
Vox Sang ; 117(8): 1016-1026, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35609012

RESUMEN

BACKGROUND AND OBJECTIVES: Most of the 233 worldwide cases of variant Creutzfeldt-Jakob disease (vCJD) have been reported in the United Kingdom and 3 have been associated with transfusion-transmission. To mitigate the potential vCJD risk to blood safety, Australian Red Cross Lifeblood imposes restrictions on blood donation from people with prior residency in, or extended travel to, the United Kingdom during the risk period 1980-1996. We have modified a previously published methodology to estimate the transfusion-transmission risk of vCJD associated with fresh component transfusion in Australia if the UK residence deferral was removed. MATERIALS AND METHODS: The prevalence of current pre-symptomatic vCJD infection in the United Kingdom by age at infection and genotype was estimated based on risk of exposure to the bovine spongiform encephalopathy agent for the period 1980-1996. These results were used to estimate the age-specific prevalence of undiagnosed, pre-symptomatic vCJD in the Australian population in the current year due to prior UK residency or travel. The primary model outputs were the 2020 vCJD risks/unit of vCJD contamination, transfusion-transmission (infections) and clinical cases. RESULTS: The overall (prior UK residency in and travel to United Kingdom, 1980-1996) mean risk of contamination per unit was 1 in 29,900,000. The risks of resulting vCJD transmission (infection) and clinical case were 1 in 389,000,000 and 1 in 1,450,000,000, respectively. CONCLUSION: Our modelling suggests that removing the Lifeblood donation deferral for travel to, or UK residence, would result in virtually no increased risk of vCJD transfusion-transmission and would be a safe and effective strategy for increasing the donor base.


Asunto(s)
Síndrome de Creutzfeldt-Jakob , Animales , Australia/epidemiología , Donantes de Sangre , Transfusión Sanguínea , Bovinos , Síndrome de Creutzfeldt-Jakob/epidemiología , Síndrome de Creutzfeldt-Jakob/etiología , Humanos , Reino Unido/epidemiología
15.
J Paediatr Child Health ; 58(9): 1629-1634, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35779010

RESUMEN

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.


Asunto(s)
Enfermedades Transmisibles , Bancos de Leche Humana , Australia , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Leche Humana , Pasteurización
16.
Transfus Med Hemother ; 5: 1-11, 2022 Mar 23.
Artículo en Inglés | MEDLINE | ID: mdl-35528142

RESUMEN

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel human coronavirus first identified in late 2019 and subsequently declared a worldwide pandemic in March 2020. In this review, we provide an overview of the implications of SARS-CoV-2 for blood safety and sufficiency. Summary: Approximately one-third of SARS-CoV-2 infections are asymptomatic. The reported mean incubation period typically varies from 2 to 11 days, but longer periods up to 22 days have been reported. The blood phase of SARS-CoV-2 appears to be brief and low level, with RNAaemia detectable in only a small proportion of patients, typically associated with more severe disease and not demonstrated to be infectious virus. A small number of presymptomatic and asymptomatic blood phase cases have been reported. Transfusion-transmission (TT) of SARS-CoV-2 has not been reported. Therefore, the TT risk associated with SARS-CoV-2 is currently theoretical. To mitigate any potential TT risk, but more importantly to prevent respiratory transmission in donor centers, blood services can implement donor deferral policies based on travel, disease status, or potential risk of exposure and encourage staff vaccination. Key Messages: The TT risk of SARS-CoV-2 appears to be low. The biggest risk to blood services in the current COVID-19 pandemic is to maintain the sufficiency of the blood supply while minimizing respiratory transmission of SARS-CoV-2 to donors and staff while donating blood.

17.
PLoS Med ; 18(7): e1003656, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34228725

RESUMEN

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibody neutralization response and its evasion by emerging viral variants and variant of concern (VOC) are unknown, but critical to understand reinfection risk and breakthrough infection following vaccination. Antibody immunoreactivity against SARS-CoV-2 antigens and Spike variants, inhibition of Spike-driven virus-cell fusion, and infectious SARS-CoV-2 neutralization were characterized in 807 serial samples from 233 reverse transcription polymerase chain reaction (RT-PCR)-confirmed Coronavirus Disease 2019 (COVID-19) individuals with detailed demographics and followed up to 7 months. A broad and sustained polyantigenic immunoreactivity against SARS-CoV-2 Spike, Membrane, and Nucleocapsid proteins, along with high viral neutralization, was associated with COVID-19 severity. A subgroup of "high responders" maintained high neutralizing responses over time, representing ideal convalescent plasma donors. Antibodies generated against SARS-CoV-2 during the first COVID-19 wave had reduced immunoreactivity and neutralization potency to emerging Spike variants and VOC. Accurate monitoring of SARS-CoV-2 antibody responses would be essential for selection of optimal responders and vaccine monitoring and design.


Asunto(s)
Anticuerpos Neutralizantes/inmunología , SARS-CoV-2/patogenicidad , Adulto , Anticuerpos Antivirales/inmunología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proteínas de la Nucleocápside/inmunología , SARS-CoV-2/inmunología
18.
Vox Sang ; 116(2): 155-166, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32965726

RESUMEN

BACKGROUND AND OBJECTIVE: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus, first identified in China at the end of 2019 and has now caused a worldwide pandemic. In this review, we provide an overview of the implications of SARS-CoV-2 for blood safety and sufficiency. MATERIAL AND METHOD: We searched the PubMed database, the preprint sites bioRxiv and medRxiv, the websites of the World Health Organization, European Centre for Disease Prevention and Control, the US Communicable Diseases Center and monitored ProMed updates. RESULTS: An estimated 15%-46% of SARS-CoV-2 infections are asymptomatic. The reported mean incubation period is 3 to 7 days with a range of 1-14 days. The blood phase of SARS-CoV-2 appears to be brief and low level, with RNAaemia detectable in only a small proportion of patients, typically associated with more severe disease and not demonstrated to be infectious virus. An asymptomatic blood phase has not been demonstrated. Given these characteristics of SARS-CoV-2 infection and the absence of reported transfusion transmission (TT), the TT risk is currently theoretical. To mitigate any potential TT risk, but more importantly to prevent respiratory transmission in donor centres, blood centres can implement donor deferral policies based on travel, disease status or potential risk of exposure. CONCLUSION: The TT risk of SARS-CoV-2 appears to be low. The biggest risk to blood services in the current COVID-19 pandemic is to maintain the sufficiency of the blood supply while minimizing respiratory transmission of SARS-CoV-19 to donors and staff while donating blood.


Asunto(s)
Seguridad de la Sangre , COVID-19/sangre , COVID-19/prevención & control , COVID-19/virología , Reacción a la Transfusión/prevención & control , Transfusión Sanguínea , Geografía , Humanos , ARN Viral/análisis , Medición de Riesgo , SARS-CoV-2 , Administración de la Seguridad , Organización Mundial de la Salud
19.
Vox Sang ; 116(3): 273-280, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32702163

RESUMEN

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.


Asunto(s)
Donantes de Sangre/estadística & datos numéricos , Flebotomía/efectos adversos , Plasmaféresis/efectos adversos , Síncope Vasovagal/etiología , Adulto , Anciano , Australia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
20.
Vox Sang ; 116(3): 336-341, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33107094

RESUMEN

BACKGROUND AND OBJECTIVES: Based on the Council of Europe directive which dictates regulatory requirements in Australia, blood donors are currently deferred from donating for 4 months after an endoscopic procedure if either polyps were removed or a biopsy sample was taken. We aimed to assess the incidence of blood-borne viruses (BBVs) (HIV, hepatitis B and C) in blood donors who donated after an endoscopic procedure and evaluate the risk to blood safety through risk modelling. MATERIALS AND METHODS: Donors from 1/1/2013 to 31/12/2017 with an endoscopy deferral on their blood donor file with pre- and post-BBV testing were analysed to determine an incidence of BBVs using standard methods. The standard blood donor cohort was used as a comparator group. Using the incidence of endoscopies and BBV risk, the total residual risk estimate of allowing donors to return postendoscopy without restriction was calculated. RESULTS: The incidence of a BBV postendoscopy in this large cohort of 16,283 where testing has been confirmed postendoscopy was zero (95% CI 0-0·000105). The upper confidence interval of the zero events is 10·5 per 100 000 donations. Total positive donations from 2017 repeat donors were 1·87 per 100 000 (95% CI 0·0000117-0·0000277). Sensitivity analysis demonstrated that the residual risk remained negligible under realistic worst-case scenarios. CONCLUSION: A BBV endoscopy deferral is not required for blood safety in Australia. The presented data has enabled us to submit a request for an exemption to our regulator, which has been approved and the policy change subsequently implemented by Lifeblood on 4/4/2020.


Asunto(s)
Donantes de Sangre/estadística & datos numéricos , Seguridad de la Sangre , Endoscopía/efectos adversos , Infecciones por VIH/epidemiología , Hepatitis B/epidemiología , Hepatitis C/epidemiología , Australia/epidemiología , Femenino , Infecciones por VIH/etiología , Hepatitis B/etiología , Hepatitis C/etiología , Humanos , Incidencia , Masculino
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