Malaria blood safety policy in five non-endemic countries: a retrospective comparison through the lens of the ABO risk-based decision-making framework.

BACKGROUND: In non-endemic countries, malaria risk is addressed by selectively testing or deferring at-risk donors. These policy decisions were made using a variety of decision-making frameworks prior to the development of the Alliance of Blood Operators Risk Based Decision-Making Framework. It is unclear whether the range of items assessed in the decision-making process would be increased if the Framework were used. We compared assessments considered in France, England and Australia for decisions to implement selective testing, plus donor selection criteria (Canada and the USA included) with those recommended by the Framework. MATERIALS AND METHODS: Elements of the Framework were identified: the intervention, safety threat, availability threat, donor impact, financial implications, risk communication, stakeholder and regulatory aspects. Decisions about selective testing and donor selection criteria were analysed separately. Assessments were compared against elements of the Framework and the level of concern for considerations rated. RESULTS: Sufficiency of the blood supply (plus safety in France) were the drivers for selective testing; main trade-offs were high operational impact and cost. In three donor criteria examples, transfusion-transmitted malaria cases prompted the change. Social concerns were high in France and Australia, political/regulatory concerns influenced decisions in France, Australia and Canada, while sufficiency was a consideration in Canada and the USA. Decision trade-offs involved moderate operational impact. DISCUSSION: The assessments considered in each country were generally consistent with the assessments recommended by the Framework. When data supported quantified risk assessment, safety and operational feasibility had the greatest weight. When risk was not well defined, contextual factors such as social and political concern had greater weight.

Hepatitis A: an epidemiological survey in blood donors, France 2015 to 2017.

Since mid-2016, hepatitis A virus (HAV) outbreaks, involving predominantly men who have sex with men (MSM), have affected countries in Europe and overseas. In France, HAV screening of blood donations in 2017 revealed a HAV-RNA prevalence ca fivefold higher than during 2015-16 (4.42/106 vs 0.86/106; p = 0.0005). In 2017, despite a higher male-to-female ratio (5.5 vs 0.7) and the identification of MSM-associated outbreak strains, only one of 11 infected male donors self-reported being a MSM.

Inclusion of human immunodeficiency virus Type 2 (HIV-2) in a multiplex transcription-mediated amplification assay does not affect detection of HIV-1 and hepatitis B and C virus genotypes: a multicenter performance evaluation study.

BACKGROUND: The Ultrio Elite assay (Hologic/Grifols) runs on the Panther blood screening system and is comparable to the Ultrio Plus assay apart from the addition of oligonucleotides for human immunodeficiency virus Type 2 (HIV-2) detection. In this multicenter evaluation study the analytical sensitivity and genotype detection efficiency of the two assay versions were compared. STUDY DESIGN AND METHODS: The analytical sensitivity and genotype detection efficiency were analyzed by replicate (18-303) testing of 27 hepatitis B virus (HBV), hepatitis C virus (HCV), HIV-1, and HIV-2 standard dilution panels calibrated in international units (IUs) and copies/mL. A wider range of subgenotypes was tested at 25 copies/mL. Specificity was evaluated in 30,756 donor samples. RESULTS: The 95% lower limits of detection (LODs) in Ultrio Elite assay on WHO standards were 4.6, 7.3, 23.5, and 23.3 IU/mL for HBV, HCV, HIV-1, and HIV-2, respectively, and ranged from 13 to 44, 7 to 23, 6 to 15, and 9 copies/mL on genotype panels of the respective viruses. Comparable LODs had been previously found on the same panels with the Ultrio Plus assay. The specificity was 99.95% on initial test and 100% in the repeat test algorithm. CONCLUSION: The change in the oligonucleotide design of the Ultrio Elite assay to enable HIV-2 detection has not affected the analytical sensitivity for the other viruses regardless of the genotype. Genotype reference panels are instrumental to compare the sensitivity of nucleic acid test assay versions and could serve as an alternative to seroconversion panels.

The Epidemiology of Imported Malaria and Transfusion Policy in 5 Nonendemic Countries.

Addressing risk of imported malaria is complicated by 5 human species of Plasmodium, semi-immunity in donors with long-term exposure, increasing travel and immigration, changing risk in endemic areas, and limitations of screening assays. To gain insight into policy formulation, we have compiled epidemiologic data from 5 countries with different policies involving either deferral (the United States and Canada) or selective testing (France, England, and Australia). The greatest risk is from semi-immune former residents of endemic areas, but the greatest impact on sufficiency (donor loss) is from low-risk short-term travel. France and the UK have the highest rates of travel to Africa where most malaria cases originate. The UK has substantial travel to the Indian subcontinent where Plasmodium vivax cases are more common, and Australia, to Southeast Asia and Papua New Guinea. In the United States and Canada, malaria risk travel is more often to lower risk areas such as Mexico and the Caribbean. Each country has imported cases, predominantly Plasmodium falciparum and P. vivax, although data are incomplete. Transfusion-transmitted malaria has been rare over the last 10 years, generally involving P. falciparum, but there were 2 US cases of Plasmodium malariae. Uncertainty due to limitations of epidemiologic data and reliance on donors' answers underpins much of the complexity of policy formulation. Variability in policies between countries reflects not only epidemiologic differences but also operational considerations, donor demographics, regulatory approaches, and public pressure to react to rare transfusion-transmitted malaria cases. Testing reduces the operational impact of addressing the very small risk from travelers and offers improvement over deferral by testing all former residents of endemic areas. Notwithstanding current international regulatory requirements, policies have "evolved" through a series of additions and revisions as concerns and issues arose, with resultant variability in donor selection criteria.