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.

The use of banked skin in the Burns Centre of Verona.

BACKGROUND: The use of glycerol and subsequent research enabling the conservation of tissues over time have led to the establishment and development of tissue banks, first in the USA and then in Europe. The Verona Tissue Bank was instituted in 2003 as the Regional Centre for the storage of skin and bone, adding to the already existing Italian banks at Turin, Milan, Cesena and Siena. This retrospective study analyses the use of banked skin (autologous and allogeneic grafts) from April 2003 (date of starting activity) to December 2007, in 171 patients with burns and four with necrotising fasciitis at the Burns Centre of Verona. MATERIALS AND METHODS: Homologous skin was used for superficial and deep skin burns to protect the residual structures, thus facilitating healing by spontaneous re-epithelialisation, and for deep burns after eschar removal to clean and prepare the base of the lesion for the definitive autologous graft. The placement of a homologous graft alone led to spontaneous healing of lesions in 65 patients (36 aged >15 years and 29 aged <15 years) with superficial skin burns, while the remaining 106 patients (84 aged >15 years and 22 aged <15 years) with deeper burns underwent surgery. CONCLUSIONS: The results obtained confirm the essential role of banked skin in covering superficial burns in order to protect important underlying structures and in deep burns by guaranteeing a good preparation of the base of the lesion for the subsequent definitive autologous graft.

Evaluation of cryopreserved donor skin viability: the experience of the regional tissue bank of Verona.

BACKGROUND: Allogeneic human skin removed from cadaveric donors is the covering of choice for deep burns, since it accelerates the re-epithelialisation of autologous skin. In this study we evaluated the cellular viability of cryopreserved skin at the regional tissue bank of Verona (Italy). METHODS: From 1st June 2007 to 30th September 2007, tests of cutaneous cell viability were carried out on 21 consecutive skin donors using the MTT (tetrazolium salt) method on samples prior to freezing and on thawed samples after a period of cryopreservation. RESULTS: The mean percentage viability was 45.1% (+/-20.1%), which is similar to results obtained in other tissue banks. It was noted that viability decreased with increasing age of the donor. CONCLUSIONS: The results of the evaluation of cutaneous cell viability document the validity of the skin cryopreservation procedure in use at the tissue bank in Verona.

Adverse reactions in blood and apheresis donors: experience from two Italian transfusion centres.

BACKGROUND: Blood and apheresis donations are widely considered to be safe with a low incidence of adverse reactions and injuries; however, data reported in the medical literature on the prevalence of adverse events in donors and studies on the predictive risk factors for donor reactions are limited and contradictory. METHODS: From January 2002 to December 2006 we recorded every adverse reaction verified during 240,596 consecutive blood and apheresis donations (183,855 homologous whole blood donations, 6,669 autologous whole blood donations, 38,647 plasmapheresis, 2,641 plateletpheresis and 8,784 multicomponent donations) at the Italian Transfusion Centres of Verona and Ragusa,. RESULTS: Using a special, pre-arranged form within the quality system, a total of 686 adverse reactions (related to 0.28% of all donations) were recorded. Vasovagal reactions, mostly of mild intensity, were the most commonly observed adverse reactions, with a frequency of 0.20% (487/ 240,596). The frequency of the vasovagal reactions varied according to the different types of donation, being 0.19% (346/183,855) for homologous whole blood donations, 0.24% (16/6,669) for autologous whole blood donations, 0.16% (63/38,647) for plasmapheresis, 0.68% (18/2,641) for plateletpheresis and 0.49 (43/8,784) for multicomponent donations. Citrate toxicity was reported in 0.38% (189/50,072) of apheresis donations. Severe adverse reactions were very rare, as they occurred in 0.004% of the donations (10/240,596). CONCLUSIONS: In conclusion, the results of our 5-year survey document that apheresis and blood donation are safe procedures for the donor with a low incidence of adverse reactions; the adverse reactions that did occur were mostly mild and resolved rapidly.

Evaluation of the Roche cobas s 201 system and cobas TaqScreen multiplex test for blood screening: a European multicenter study.

BACKGROUND: The Roche cobas TaqScreen test, an automated, multiplex nucleic acid test for blood screening for hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA, human immunodeficiency virus type 1 (HIV-1) groups M and O, and HIV-2 RNA, on the cobas s 201 platform, was evaluated by six European blood screening laboratories. STUDY DESIGN AND METHODS: The 95 percent limit of detection (LOD) of the cobas TaqScreen test for HBV, HCV, and HIV-1, using dilutions of the WHO International Standards, were evaluated. The clinical performance was determined by testing between 2000 to 6000 routine donor samples. Some laboratories evaluated the robustness, cross-contamination, and workflow. RESULTS: The mean 95 percent LOD (95% lower and upper confidence intervals) for HBV, HCV, and HIV-1 across all the laboratories were 3.8 (range, 3.0-5.2), 10.8 (range, 8.4-14.4), and 56.7 (range, 43.0-79.2) IU/mL, respectively. A total of 23,716 donors were tested in pools of 6. Fourteen initially reactive pools were detected, of which 6 contained a reactive donation, giving a positive predictive value of the pool results of 43 percent. One of the reactive donations was a HBV yield case (hepatitis B surface antigen-negative/anti-HBc-positive). Evaluation of the workflow for the system showed that an optimized batch loading in which a pipettor (Hamilton Microlab Star IVD) was utilized to half capacity was better than a full batch loading. CONCLUSION: The 95 percent LOD for the three viruses were comparable to those obtained by Roche. The test and platform were shown to be sensitive, specific, flexible, and robust.

Fresh frozen homologous bone in oral surgery: case reports.

Intraoral bone defects may be treated using autologous grafts, homologous grafts, heterologous grafts or synthetic products. Autologous bone is now considered the gold standard for bone grafting procedures. Homologous fresh frozen bone, provided by bone banks, is frequently utilized by orthopaedic surgeons because it is considered a safe material from immunological and viral points of view. In the cases reported here, homologous bone was used to repair some osseous defects without changing the surgical protocol utilized for autologous bone procedures. The main advantages of this strategy are low morbidity, shorter surgical times, more comfort and less risk of infection for the patient as well as the greater availability of bone.

Association study of dysbindin gene with clinical and outcome measures in a representative cohort of Italian schizophrenic patients.

There is evidence suggesting that Dysbindin (DTNBP1) is a susceptibility gene for schizophrenia in Caucasian, Chinese, and Japanese populations. We sought to determine if dysbindin was associated with schizophrenia and its symptoms in a representative group of schizophrenic patients from a Community-Based Mental Health Service (CMHS) in Verona, Italy. A prevalence cohort of schizophrenic patients (n = 141) was assessed at baseline and then 3 and 6 years later. Eighty patients and 106 healthy controls were genotyped for polymorphisms in dysbindin. We tested if diagnosis, clinical symptoms as measured by the Brief Psychiatric Rating Scale (BPRS), and functioning as measured by the Global Assessment of Functioning Scale (GAF), were associated with the presence of certain dysbindin polymorphisms. Finally, using the longitudinal clinical data, we tested if patients carrying dysbindin high-risk haplotypes had a more unfavorable longitudinal clinical outcome. A trend towards statistical association (P = 0.058) between schizophrenia and rs2619538 was found. Using GENECOUNTING software, we found that rs2619538-P1583 (P = 0.048), P1320-P1757 (P = 0.034), and rs2619538-P1583-P1578 (P = 0.040) haplotypes occurred more often in cases compared to controls before correction for multiple testing. The rs2619538-P1583 haplotype was more likely to be transmitted to subjects with more severe and persistent psychopathology. These preliminary results are compatible with the view that DTNBP1 is a susceptibility factor for schizophrenia, and is associated with worse psychopathology.