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.

Attitudes and willingness to donate blood among gay and bisexual men in Australia.

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.

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.

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.

Validation of an automated immunoglobulin G-only cytomegalovirus (CMV) antibody screening assay and an assessment of the risk of transfusion transmitted CMV from seronegative blood.

BACKGROUND: Cytomegalovirus (CMV) antibody donor screening assays have predominantly included both immunoglobulin G (IgG) and immunoglobulin M (IgM) detection. However, since in the majority of cases both CMV IgG and IgM are detected concomitantly during early seroconversion, CMV assays based only on IgG are now widely applied for donor screening. STUDY DESIGN AND METHODS: The performance of an automated microparticle CMV IgG assay (Abbott AxSYM CMV IgG microparticle enzyme immunoassay [MEIA]) was compared with an established total antibody blood screening assay (Abbott CMV Total AB EIA). Sensitivity and specificity were assessed using 5050 random blood donors and 13 seroconversion panels. A risk analysis was undertaken to estimate the residual risk of transfusion-transmitted CMV (TT-CMV) from presumptive seronegative blood components. RESULTS: The EIA achieved marginally (but not significantly) better resolved sensitivity (100%) than the AxSYM IgG assay (99.93%). The AxSYM IgG resolved specificity (99.34%) was superior to the EIA (96.4%). This superiority was maintained (98.61%) when a modified cutoff was applied to the AxSYM IgG assay to achieve 100 percent resolved sensitivity. The seroconversion sensitivities of the EIA and the AxSYM IgG were equivalent, detecting the same bleed as positive in the majority of the seroconversion panels tested. The median TT-CMV residual risk estimate for the two assays was approximately 1 in 66,000 (range, 42,000-165,000). CONCLUSION: The AxSYM IgG MEIA is suitable for blood donor screening and was optimized by applying a modified cutoff of 9 AU per mL. The modeling predicts that implementing the AxSYM IgG assay would not negatively impact the already very low risk of TT-CMV associated with seronegative blood components in Australia.