Anthony J. Keller

Assessing 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.

BACKGROUND : Risk modeling is now the most practical method of estimating the residual risk of viral transmission in developed countries. One method of assessing the accuracy of a risk model is to measure the observed against the predicted outcome after implementing a new screening method. The primary objective of this paper is to assess the accuracy of three published models in predicting the impact of implementing HIV and HCV NAT in Australia.

Comparison of two automated nucleic acid testing systems for simultaneous detection of human immunodeficiency virus and hepatitis C virus RNA and hepatitis B virus DNA

BACKGROUND: Recently developed nucleic acid testing (NAT) assays incorporating simultaneous detection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) have made HBV NAT screening more feasible for blood services. This study compared the performance of two “multiplex” NAT assays and their automated testing platforms.

Serum hepcidin as a diagnostic test of iron deficiency in premenopausal female blood donors

Background Currently used indicators of iron status have limitations. Hepcidin, a key regulator of iron metabolism, is reduced in iron deficiency. We sought to determine the properties of hepcidin as a diagnostic test of iron deficiency. Design and Methods Sera from female, non-anemic, whole blood donors were analyzed for hepcidin (enzyme-linked immunosorbent assay), ferritin, soluble transferrin receptor and C-reactive protein. Iron deficiency was defined as (i) serum ferritin less than 15 ng/mL or (ii) soluble transferrin receptor /log(ferritin) index greater than 3.2 if the C-reactive protein concentration was less than 10 mg/L, or greater than 2.2 if the C-reactive protein concentration was greater than 10 mg/L). Receiver operating characteristic curves were plotted to determine the overall utility and identify optimal cut-points of hepcidin as a test of iron deficiency. Results In 261 blood donors the prevalence of iron deficiency defined by ferritin concentration was 59/261 [22.6% (17.5, 27.7)], whereas defined by soluble transferrin receptor/log(ferritin) index it was 53/261 [20.4% (15.4, 25.2)]. The 95% reference range of hepcidin concentration in the iron-replete population was 8.2–199.7 ng/mL. The area under the receiver operating characteristic curve for hepcidin compared with ferritin concentration less than 15 ng/mL was 0.87 (0.82, 0.92), while that compared with the soluble transferrin receptor /log(ferritin) index was 0.89 (95% CI 0.84, 0.93). For a diagnosis of iron deficiency defined by the soluble transferrin receptor/log(ferritin) index, hepcidin less than 8 ng/mL had a sensitivity of 41.5% and a specificity of 97.6%, while hepcidin less than 18 ng/mL had a sensitivity of 79.2% and a specificity of 85.6%. Conclusions Serum hepcidin concentration may be a useful indicator of deficient iron stores. Further studies are required to evaluate the role of hepcidin in the diagnosis of iron deficiency in other groups of patients.

Detection of bacterial contamination of platelet concentrates.

R. N. I. Pietersz, C. P. Engelfriet, H. W. Reesink, E. M. Wood, S. Winzar, A. J. Keller, J. T. Wilson, G. Henn, W. R. Mayr, S. Ramírez-Arcos, M. Goldman, J. Georgsen, P. Morel, P. Herve, G. Andeu, A. Assal, E. Seifried, M. Schmidt, M. Foley, C. Doherty, P. Coakley, A. Salami, E. Cadden, W. G. Murphy, M. Satake, D. de Korte, V. Bosnes, J. Kjeldsen-Kragh, C. McDonald, M. E. Brecher, R. Yomtovian & J. P. AuBuchon

Reducing the risk of transfusion‐transmissible viral infection through blood donor selection: the Australian experience 2000 through 2006

BACKGROUND: Selection of voluntary donors who are at low risk of transfusion‐transmissible viral infection (TTVI) is central in maintaining the safety of the blood supply. Evaluation of its effectiveness and the dynamics of the process may offer opportunities to further improve transfusion safety.

The risk of dengue transmission by blood during a 2004 outbreak in Cairns, Australia

BACKGROUND: Dengue virus (DENV) is a Flavivirus transmitted by the Aedes mosquito. The related arbovirus, West Nile virus, has been shown to be transfusion transmitted, which, added to the four recorded dengue transfusion‐associated cases, indicates that DENV is also transfusion transmitted. The purpose of this study was to assess the risk of transfusion‐transmitted DENV during a 2004 outbreak in the Australian city of Cairns.

No evidence of a significantly increased risk of transfusion-transmitted human immunodeficiency virus infection in Australia subsequent to implementing a 12-month deferral for men who have had sex with men.

BACKGROUND: Male‐to‐male sex is the predominant route of human immunodeficiency virus (HIV) transmission in Australia and since the early 1980s blood services in Australia have deferred donors for this practice for at least 5 years. This retrospective analysis assesses the impact on HIV prevalence of implementing an abridged 12‐month deferral for male‐to‐male sex.

Measures to prevent transfusion-related acute lung injury (TRALI)

H. W. Reesink, J. Lee, A. Keller, P. Dennington, J. Pink, R. Holdsworth, H. Schennach, M. Goldman, T. Petraszko, J. Sun, Y. Meng, K. Qian, V. Rehacek, P. Turek, T. Krusius, E. Juvonen, P. Tiberghien, D. Legrand, G. Semana, J. Y. Muller, J. Bux, A. Reil, C. K. Lin, H. Daly, E. McSweeney, L. Porretti, N. Greppi, P. Rebulla, H. Okazaki, S. A. Sanchez-Guerrero, H. A. Baptista-Gonzalez, C. Martinez-Murillo, A. Guerra-Marquez, H. Rodriguez-Moyado, R. A. Middelburg, J. C. Wiersum-Osselton, A. Brand, C. van Tilburg, D. Dinesh, J. Dagger, P. Dunn, E. Brojer, M. Letowska, K. Maslanka, E. Lachert, M. Uhrynowska, E. Zhiburt, M. Palfi, G. Berlin, B. M. Frey, L. Puig Rovira, E. Muniz-Diaz, E. Castro, C. Chapman, A. Green, E. Massey, N. Win, L. Williamson, C. C. Silliman, D. J. Chaffin, D. R. Ambruso, N. Blumberg, P. Tomasulo, K. J. Land, P. J. Norris, O. C. Illoh, R. J. Davey, R. J. Benjamin, A. F. Eder, L. McLaughlin, S. Kleinman & S. Panzer

The efficacy of a malarial antibody enzyme immunoassay for establishing the reinstatement status of blood donors potentially exposed to malaria

Background and Objectives  The two key objectives of the study were, first, to evaluate the sensitivity and specificity of a recombinant antigen‐based malarial enzyme‐linked immunoassay (EIA) and, second, to estimate the risk associated with implementing this test with a shortened cellular component restriction period (6 months rather than the standard 12–36 months) for blood donors with a malarial risk exposure.

Deferral of males who had sex with other males

Donor history questionnaires for the determination of blood donor eligibility are a critical layer of blood safety. Early in the course of the AIDS epidemic in North America homosexual men with multiple partners were identified as one of the segments of the population with the highest risk of infection. Voluntary deferral of this group from blood donation led to a dramatic decrease in transfusion-transmitted HIV even before testing was introduced. In the early 1980s blood donors were deferred in England, the US and other nations, if they were ‘homosexual males with multiple partners’. After the implementation of HIV testing in 1985, the majority of the HIV-positive donors identified revealed ‘men having sex with men’ (MSM) behavior, leading the US Food and Drug Administration (FDA) to recommend indefinite deferral of all men who ‘have had sex with men, even once since 1977’; many other regulators and jurisdictions have enacted similar criteria. Three decades later, despite the recognition of other modes of transmission, MSM donors are still among the population segments with the highest prevalence and incidence of HIV in countries around the world. No other donor eligibility criterion has generated as much controversy or public discourse [1,2]. Proponents for change point out that in many countries other key components of blood safety such as donor testing and blood center process control have improved vastly, reducing the contribution of donor questioning to safety. Gay advocates in particular argue that donor selection policies based on MSM are discriminatory against gay and bisexual men in that they amount to a de facto permanent exclusion on the grounds of sexual preference, and are unfair, as other groups with similar risks of HIV infection are allowed to donate blood after shorter time-period deferrals designed to cover the seroconversion window. On the opposite side of the discussion, recipient advocacy groups and regulators are understandably adverse to any change that is not centered on improving safety. Recipient groups argue that they have suffered greatly due to transmission of HIV and HCV by transfusion, and they will be the bearers of any increase in risk that may result from policy changes. Because both MSM and recipients are vulnerable groups that have suffered in the past, the debate over possible changes in criteria has ethical, societal, and emotional dimensions not seen in discussions concerning other donor selection criteria. Of particular concern to blood operators is the prospect that young eligible donors may be dissuaded from donating blood to institutions that are perceived to act in a discriminatory and unfair fashion. This International Forum seeks to describe approaches to this issue and challenges to the status quo, in a snapshot in time. Since it is extremely difficult to obtaindatatoevaluatethepossibleimpactofpolicy changes made to address concerns expressed by advocacy groups, comparison of international practice is particularly valuable, since we may learn from approaches implemented in other jurisdictions. We received responses from 24 respondents representing countries on six continents. In most, but not all, the MSMpolicy isdetermined atthe national level. The following questions were asked of the respondents: