Reconsideration of blood donation testing strategy for human T‐cell lymphotropic virus in Australia

Claire E. Styles · Clive R. Seed · Veronica C. Hoad · Silvana Gaudieri · A. J. Keller

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Blood donation and transfusion practices Blood transfusion and management T-cell and Retrovirus Studies

Abstract

BACKGROUND AND OBJECTIVES: Universal testing of blood donations for human T-cell lymphotropic virus (HTLV) in Australia may no longer be appropriate given the low prevalence of HTLV infection and the mitigating effect of universal leucodepletion for cellular components. This study aimed to determine the most appropriate HTLV testing strategy using the Risk-Based Decision-Making Framework for Blood Safety. MATERIALS AND METHODS: The risk of HTLV transfusion-transmission using three testing strategies (universal, new-donor and no testing) and cost-effectiveness of the first two strategies were assessed using adaptations of published mathematical models. RESULTS: The overall prevalence for 2004-2014 was three HTLV-positives per million donations. It was estimated that annually, universal testing incurred a cost of approximately AUD $3 million and prevented 83 HTLV-positive cellular components from being issued, and new-donor testing cost approximately $225 000 and prevented 81 components. The number of cases of transfusion-transmitted HTLV and HTLV-associated disease prevented per year by universal and new-donor testing was essentially equivalent. According to preset risk thresholds, the risk of transfusion-transmission was negligible for universal and new-donor testing, and minimal without testing. CONCLUSION: Transfusion-transmission of HTLV is a minimal risk in Australia even without testing. However, any revision of testing strategy must consider not only risk and cost-effectiveness, but also stakeholder, ethical and regulatory perspectives. Considering all relevant criteria, new-donor testing is judged the optimal strategy because it is able to achieve almost the same outcomes as universal testing, at a fraction of the cost.

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1999The health and welfare of Australia's Aboriginal and Torres Strait Islander peoples 1999 2005Residual risk of transfusion transmitted human immunodeficiency virus, hepatitis B virus, hepatitis C virus and human T lymphotrophic virus 2002Assessing the accuracy of three viral risk models in predicting the outcome of implementing HIV and HCV NAT donor screening in Australia and the implications for future HBV NAT 2008Blood safety strategies for human T‐cell lymphotropic virus in Europe 1998Screening for human T cell leukaemia/lymphoma virus among blood donors in Sweden: cost effectiveness analysis 2011Cost‐effectiveness of additional blood screening tests in the Netherlands

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2018Risk‐based decision making in transfusion medicine 2019Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework.2018Human T‐cell lymphotropic virus: A simulation model to estimate residual risk with universal leucoreduction and testing strategies in Canada 2019Health economic implications of testing blood donors in South Africa for HTLV 1 & 2 infection

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