Preparedness and activities of the anti-SARS-CoV-2 convalescent plasma bank in the Veneto region (Italy): An organizational model for future emergencies.

BACKGROUND: Convalescent plasma (CP) has been used in the past in various pandemics, in particular in H1N1, SARS and MERS infections. In Spring 2020, when ongoing the SARS-CoV-2 pandemics, the Veneto Region (V-R) has proposed setting-up an anti-SARS-CoV-2 CP (CCP) Bank, with the aim of preparing a supply of CCP immediately available in case of subsequest epidemic waves. MATERIALS AND METHODS: Key-points to be developed for a quick set-up of the V-R CCP Bank have been recruitment of donors recovered from COVID-19 infection, laboratory analysis for the biological qualification of the CCP units, including titre of neutralizing antibodies and reduction of pathogens, according to National Blood Centre (CNS) Directives, adaptation of the V-R Information Technology systems and cost analysis. Some activities, including diagnostic and viral inactivation processes, have been centralized in 2 or 3 sites. Laboratory analysis upon preliminary admission of the donor included all tests required by the Italian laws and the CNS directives. RESULTS: From April to August 2020, 3,298 people have contacted the V-R Blood Transfusion Services: of these, 1,632 have been evaluated and examined as first time donors and those found to be suitable have carried out 955 donations, from which 2,626 therapeutic fractions have been obtained, at a cost around 215,00 Euro. Since October 2020, the number of COVID-19 inpatients has had a surge with a heavy hospital overload. Moreover, the high request of CCP therapy by clinicians has been just as unexpected, showing a wide therapeutic use. CONCLUSIONS: The organizational model here presented, which has allowed the rapid collection of a large amount of CCP, could be useful when facing new pandemic outbreaks, especially in low and middle income countries, with generally acceptable costs.

Chagas disease and transfusion medicine: a perspective from non-endemic countries.

In the last decades, increasing international migration and travel from Latin America to Europe have favoured the emergence of tropical diseases outside their "historical" boundaries. Chagas disease, a zoonosis endemic in rural areas of Central and South America represents a clear example of this phenomenon. In the absence of the vector, one of the potential modes of transmission of Chagas disease in non-endemic regions is through blood and blood products. As most patients with Chagas disease are asymptomatic and unaware of their condition, in case of blood donation they can inadvertently represent a serious threat to the safety of the blood supply in non-endemic areas. Since the first cases of transfusion-transmitted Chagas disease were described in the last years, non-endemic countries began to develop ad hoc strategies to prevent and control the spread of the infection. United States, Spain, United Kingdom and France first recognised the need for Trypanosoma cruzi screening in at-risk blood donors. In this review, we trace an up-to-date perspective on Chagas disease, describing its peculiar features, from epidemiological, pathological, clinical and diagnostic points of view. Moreover, we describe the possible transmission of Chagas disease through blood or blood products and the current strategies for its control, focusing on non-endemic areas.

Plasma for fractionation in a public setting: cost analysis from the perspective of the third-party payer.

BACKGROUND: In Italy, within the legal mandate to pursue national self-sufficiency of plasma-derived medical products, the Regions are starting to organise trade to offset imbalances between need and availability. It is, therefore, necessary to determine the full cost to the Regions of plasma collection and handling. Here we report an analysis of plasma production costs in the Department of Transfusion Medicine of Verona Province, Veneto Region. MATERIALS AND METHODS: Plasma is obtained from voluntary, non-remunerated donors from either whole blood or apheresis donation, and in Verona it is collected, validated and distributed only in Regional Health Service facilities, and then delivered to industry for processing. The amounts and costs of materials and activities needed to collect, produce, validate and distribute plasma were obtained from the Department of Transfusion Medicine. Attributable overhead expenses were assumed at 15% of direct costs. When plasma was collected as part of whole blood or from multi-component apheresis, joint costs (the costs of the common manufacturing process before the separation) were allocated to the plasma based on the tariff for single components, taken as proxy of the willingness to pay for them. In an alternative scenario plasma recovered from whole blood donations was considered a by-product. RESULTS: The estimated full cost of each valid unit of plasma derived from whole blood, multi-component apheresis, and plasma-apheresis was about € 30, € 73 and € 170, respectively. The estimated total cost per litre of plasma was € 113 for collection from whole blood and € 276 for collection from apheresis. When plasma recovered from whole blood donations was considered a by-product, its cost per litre was estimated to be € 26. DISCUSSION: Our results suggest that the Italian donor-based system, in addition to its ethical and social values, can supply plasma at an affordable cost, comparable (albeit slightly higher) with costs in other recent analyses.