A donor safety evidence literature review of the short- and long-term effects of plasmapheresis.

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.

New tatt? We're ok with that! Relaxing the tattoo deferral for plasmapheresis donors maintains safety and increases donations.

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.

Has the frequency of ABO RhD blood groups in Australian blood donors changed as a result of the removal of the variant Creutzfeldt-Jakob disease-based deferral?

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.

Perceived risk of HIV transmission by blood transfusion among gay, bisexual, and other men who have sex with men (gbMSM) in Australia.

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.

Is dual testing for hepatitis C necessary? Modelling the risk of removing hepatitis C antibody testing for Australian blood donations.

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.

Removal of UK-donor deferral for variant Creutzfeldt-Jakob disease: A large donation gain in Australia.

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.

Removing hepatitis C antibody testing for Australian blood donations: A cost-effectiveness analysis.

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.

Risk of variant Creutzfeldt-Jakob disease transmission by blood transfusion in Australia.

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.

Severe Acute Respiratory Syndrome Coronavirus 2 and Blood Safety: An Updated Review.

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.

SARS-CoV-2 neutralizing antibodies: Longevity, breadth, and evasion by emerging viral variants.

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.

Severe acute respiratory syndrome coronavirus-2: implications for blood safety and sufficiency.

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.

Endoscopies, blood-borne viruses and blood donors: time to move on from precaution.

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.

Effect of HIV pre-exposure prophylaxis (PrEP) on detection of early infection and its impact on the appropriate post-PrEP deferral period.

INTRODUCTION: HIV antivirals for pre-exposure prophylaxis (PrEP) are known to affect detection of early HIV infection through suppression of viral load and delayed seroconversion. To cover potential delay in HIV detection associated with PrEP use by blood donors in the context of international reductions in sexual activity-based deferral periods, we analysed the available data to determine the appropriate minimum post-PrEP deferral period for blood donation. MATERIALS AND METHODS: Published cases of incident HIV infection when PrEP use was objectively demonstrable were identified, consisting principally of seroconverters from the Partners PrEP study (a clinical trial of PrEP efficacy). Data were reviewed to determine the impact of PrEP on the detection of HIV RNA, p24 Ag and seroconversion delay. RESULTS: Nucleic acid testing (NAT) detected early HIV infection in the presence of PrEP prior to or in concordance with serological testing in approximately 90% of cases. Undetectable HIV RNA would rebound to detectable levels within two months of PrEP cessation. PrEP delayed p24 antigen detection and antibody seroconversion by about 7 days. CONCLUSION: Even when daily PrEP is continued, it is likely that the majority of early HIV infections are detectable by individual donation (ID)-NAT, with p24 Ag or antibody seroconversion occurring conservatively within four weeks of exposure. HIV RNA levels also rebound rapidly in the absence of PrEP. In Australia, a three-month deferral period for blood donation after the last dose of PrEP provides an appropriate safety margin to mitigate the residual risk of transfusion-transmitted HIV.

Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.

IMPORTANCE: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. OBJECTIVE: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONS: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURES: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. CONCLUSIONS AND RELEVANCE: Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02735707.

Modeling the West Nile virus transfusion transmission risk in a nonoutbreak country associated with traveling donors.

BACKGROUND: West Nile virus (WNV) is a mosquito-borne virus and transfusion transmission (TT) has been demonstrated. The European Union and neighboring countries experience an annual transmission season. STUDY DESIGN AND METHODS: We developed a novel probabilistic model to estimate the WNV TT risk in Australia attributable to returned donors who had travelled to the European Union and neighboring countries during the 2018. We estimated weekly WNV TT risks in Australia for each outbreak country and the cumulative risk for all countries. RESULTS: Highest mean weekly TT risk in Australia attributable to donors returning from a specific outbreak country was 1 in 23.3 million (plausible range, 16.8-41.9 million) donations during Week 39 in Croatia. Highest mean weekly cumulative TT risk was 1 in 8.5 million donations (plausible range, 5.1-17.8 million) during Week 35. CONCLUSIONS: The estimated TT risk in Australia attributable to returning donors from the European Union and neighboring countries in 2018 was very small, and additional risk mitigation strategies were not indicated. In the context of such low TT risks, a simpler but effective approach would be to monitor the number of weekly reported West Nile fever cases and implement risk modeling only when the reported cases reached a predefined number or trigger point.

Blood safety assessment of hepatitis A outbreak linked to frozen pomegranate arils: are foodborne outbreaks an emerging blood safety risk?

BACKGROUND: Foodborne hepatitis A virus (HAV) outbreaks are becoming more common in high-income countries with low HAV incidence, and the associated blood safety risk may not be adequately mitigated by routine HAV risk mitigation strategies. This study describes the rapid risk modeling undertaken in response to a 2018 HAV outbreak in Australia associated with imported frozen pomegranate arils. STUDY DESIGN AND METHODS: The input parameters used in the modeling were the outbreak-associated HAV incidence, duration of viremia, population seroprevalence, and rate of symptomatic infection in adults. The number and risk of viremic components issued, cases of transfusion transmission, and symptomatic infections among recipients were estimated. RESULTS: The incidence of pomegranate-associated HAV infection among donors was very low, with fewer than 0.1 viremic fresh components estimated to have been released during the risk period. The risk of this event was less than one in 500,000, and the risks of transfusion transmission and symptomatic illness in recipients were less than one in one million. When considering only donors who had consumed the pomegranate product, the risk was much higher, with approximately one in 1000 components estimated to be viremic. CONCLUSION: Rapid risk assessment indicated that the overall risk to blood safety associated with a small foodborne outbreak of HAV was negligible. Because fresh components collected from donors known to have consumed the affected product were at high risk, these donors were identified via signage in donor centers and deferred. The contribution of factors other than outbreak size to risk management decisions is discussed.

Modeling the parvovirus B19 blood safety risk in Australia.

BACKGROUND: Three probable cases of transfusion-transmitted (TT) parvovirus B19 (B19V) occurred in Australia between 2014 and 2017. This study aimed to determine the B19V DNA prevalence among blood donors, to model the risk to recipients of fresh components, and to assess risk management options. STUDY DESIGN AND METHODS: Plasma samples from 4232 donors were tested for B19V DNA by polymerase chain reaction. Reactive samples were confirmed and viral load determined. A transmission-risk model was used to estimate recipient risk, and the risk from community exposure was estimated using seroprevalence data. RESULTS: Two samples (0.0473%, 95% confidence interval [CI] 0.0130-0.172) confirmed positive for B19V DNA had a potentially infectious viral load of 105 IU/mL or higher. The estimated risk of a TT-B19V-associated significant complication was low overall at approximately 1 in 300,000 (95% CI, 1 in 82,000 to 1 in 1 million) fresh components transfused, with 3.1 (95% CI, 0.85-11.3) complications modeled per year. Among vulnerable recipient groups, the risk was higher than 1 in 15,000 patients, but the risk from community exposure far exceeded the transfusion risk for all patient and age groups. CONCLUSION: In the context of the small contribution of transfusion to the burden of B19V disease, the significant costs that would be incurred by any strategy to reduce the risk, and given the significant uncertainties and likely overestimation of the risk, we conclude TT-B19V is a tolerable risk to blood safety, despite being high for some vulnerable recipient groups.

Tattoos, blood-borne viruses and blood donors: a blood donor cohort and risk assessment.

BACKGROUND AND OBJECTIVES: There is conflicting evidence in the literature as to whether there is a blood-borne virus (BBV) risk associated with tattoos in licensed premises. However, blood donors are currently deferred from blood donation in Australia for 4 months after any tattoo. We aimed to assess the incidence of BBVs in blood donors who declared tattoos and evaluate the risk to blood safety through risk modelling. MATERIALS AND METHODS: Donors from 2013 to 2016 with a tattoo deferral on their blood donor file with pre- and post-BBV testing were analysed to determine an incidence of BBVs using standard methods. This was compared to a 2014 cohort of whole blood donors with a deferral of 4 months due to travel to a malaria-endemic area. Using the incidence of tattoos and BBV risk, the total residual risk estimate of allowing tattooed donors to return without restriction was calculated. RESULTS: The incidence rate of BBVs in blood donors following tattoo deferral was 13·26 (95% CI 2·67-38·75) per 100 000 person-years (all were hepatitis C infections in males compared to 9·26 (95% CI 2·49-23·71) per 100 000 in blood donors following malaria deferral. If other risk factors were accounted for the risk in tattoo donors decreased to 4·4 per 100 000 person-years. The total residual risk calculation if donors with a tattoo were allowed to donate without restriction was estimated at 1 in 34 million. CONCLUSIONS: This residual risk indicates BBV deferral for donors post-tattoo in Australia is not required for blood safety.

Ross River virus in Australian blood donors: possible implications for blood transfusion safety.

BACKGROUND: Emerging transfusion-transmissible pathogens, including arboviruses such as West Nile, Zika, dengue, and Ross River viruses, are potential threats to transfusion safety. The most prevalent arbovirus in humans in Australia is Ross River virus (RRV); however, prevalence varies substantially around the country. Modeling estimated a yearly risk of 8 to 11 potentially RRV-viremic fresh blood components nationwide. This study aimed to measure the occurrence of RRV viremia among donors who donated at Australian collection centers located in areas with significant RRV transmission during one peak season. STUDY DESIGN AND METHODS: Plasma samples were collected from donors (n = 7500) who donated at the selected collection centers during one peak season. Viral RNA was extracted from individual samples, and quantitative reverse transcription-polymerase chain reaction was performed. RESULTS: Regions with the highest rates of RRV transmission were not areas where donor centers were located. We did not detect RRV RNA among 7500 donations collected at the selected centers, resulting in a zero risk estimate with a one-sided 95% confidence interval of 0 to 1 in 2019 donations. CONCLUSION: Our results suggest that the yearly risk of collecting a RRV-infected blood donation in Australia is low and is at the lower range of previous risk modeling. The majority of Australian donor centers were not in areas known to be at the highest risk for RRV transmission, which was not taken into account in previous models based on notification data. Therefore, we believe that the risk of RRV transfusion transmission in Australia is acceptably low and appropriately managed through existing risk management, including donation restrictions and recall policies.