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Background: In Italy, the use of nucleic acid testing for hepatitis B virus (HBV) in donor screening has allowed the detection of infections in the window phase, as well as the presence of occult infections which could potentially be transmitted. The aim of this study was to analyse the trends of epidemiological data focused on HBV infection in blood donors and to estimate the residual risk of transmitting HBV from both the window phase and occult infection over a 10-year period in Italy., Materials and Methods: Data were obtained from the Italian Haemovigilance System which includes the results of screening tests for transfusion transmissible infections. During the period of this survey (2009-2018), the molecular methods used for HBV screening were transcription-mediated amplification and polymerase chain reaction tests. Prevalence and incidence were calculated. The residual risk was estimated by applying the incidence-window period model for acute cases and a more recently reported model for estimating the risk due to occult infections., Results: A total of 17,424,535 blood donors and 30,842,794 donations were tested for HBV. Altogether, 6,250 donors tested positive for HBV markers: 4,782 (175.6×10 5 ) were first time donors and 1,468 (10.0×10 5 ) were repeat donors. The prevalence of HBV markers in first time donors was 275.9×10 5 in 2009, declining to 143.6×10 5 in 2018. The incidence of new infections was 3.37×10 5 in 2009 and 2.17×10 5 in 2018. The overall residual risk for HBV amounted to 1 in 2,566,854 donations calculated as the sum of risks of both acute infections in the window period (1 in 5,835,306 donations) and occult infections (1 in 4,582,270 blood units)., Discussion: In Italy, the residual risk of transfusing a blood unit infected with HBV, both from window phase and occult infections, is currently very low, amounting to levels that can be considered tolerable.

Pathogen reduction (PR) of selected blood components is a technology that has been adopted in practice in various ways. Although they offer great advantages in improving the safety of the blood supply, these technologies have limitations which hinder their broader use, e.g. increased costs. In this context, the European Centre for Disease Prevention and Control (ECDC), in co-operation with the Italian National Blood Centre, organised an expert consultation meeting to discuss the potential role of pathogen reduction technologies (PRT) as a blood safety intervention during outbreaks of infectious diseases for which (in most cases) laboratory screening of blood donations is not available. The meeting brought together 26 experts and representatives of national competent authorities for blood from thirteen European Union and European Economic Area (EU/EEA) Member States (MS), Switzerland, the World Health Organization, the European Directorate for the Quality of Medicines and Health Care of the Council of Europe, the US Food and Drug Administration, and the ECDC. During the meeting, the current use of PRTs in the EU/EEA MS and Switzerland was verified, with particular reference to emerging infectious diseases (see Appendix). In this article, we also present expert discussions and a common view on the potential use of PRT as a part of both preparedness and response to threats posed to blood safety by outbreaks of infectious disease.

Background: In Italy nucleic acid testing (NAT) became mandatory for hepatitis C virus (HCV) in 2002 and for human immunodeficiency virus (HIV) and hepatitis B virus in 2008. The aim of this study was to monitor the incidence and prevalence of HIV and HCV infections in Italian blood donors and the current residual risk of these infections after the introduction of NAT., Materials and Methods: The Italian national blood surveillance system includes data from tests used to screen for transfusion-transmissible infections. During the period of this survey (2009-2015), the NAT methods used were the transcription-mediated amplification test, for individual donor testing, and polymerase chain reaction analysis, mainly for pools of six donors. Prevalence and incidence were calculated. Three published formulae were applied to estimate the residual risk (the window period ratio model and the formulae recommended by the European Medicines Agency and the World Health Organization)., Results: Overall, 12,258,587 blood donors and 21,808,352 donations were tested for HCV and HIV. The prevalence of HCV decreased from 110.3×10 5 to 58.9×10 5 in years 2009 and 2015, respectively, while that of HIV remained stable over time (15.5×10 5 vs 15.4×10 5 ). The incidence of HCV decreased from 3.19×10 5 in 2009 to 1.58×10 5 in 2015, while the incidence of HIV did not show any significant fluctuations (average incidence 4.39×10 5 ). The residual risk of a viraemic unit entering the blood supply was estimated to be 0.077×10 6 or 1 in 12,979,949 donations for HCV and 0.521×10 6 or 1 in 1,917,250 for HIV, according to the window period ratio model, and lower with the other two formulae., Discussion: HCV infection has declined over time in both first-time and repeat donors, while the data for HIV infection are stable. All three methods employed in this study showed that the residual risk of transmitting HCV or HIV through an infected blood unit is currently very low in Italy, but there are considerable differences in estimates between methods. Thus, harmonisation of these methods is advisable.

Background: Epitheliotrophic growth factors (GF) can be supplied topically to patients with severe keratopathy through a variety of blood-derived products. We compared GF content in adult peripheral blood serum (PB-S) and cord blood serum (CB-S) as potential sources of GF. To limit inter-individual variability the assessment was performed in maternal-child pairs at the time of delivery., Material and Methods: The amounts of epidermal GF (EGF), insulin-like GF (IGF), transforming GF-beta (TGF-β), vascular endothelial GF (VEGF) in CB units collected from the umbilical vein and PB from mothers (each group n=30) were estimated by enzyme-linked immunosorbent assays. Obstetric characteristics and haematological data were recorded from the archives of the Emilia Romagna Cord Blood Bank. Statistical evaluations were performed by Wilcoxon's test and correlations between variables were determined using Spearman's (ρ) coefficient; p-values <0.05 were considered statistically significant., Results: EGF, TGF-β and VEGF levels were significantly higher in CB-S than in PB-S (median 1,254.4 vs 646.0 pg/mL, 51.3 vs 38.4 μg/mL and 686.8 vs 30 pg/mL, respectively; all p<0.0001) whereas IGF content was significantly higher in PB-S than in CB-S (159.9 vs 53.5 pg/mL, respectively; p<0.0001). In CB-S, the CD34(+) cell concentration appeared to be related to EGF, IGF and TGF-β levels whereas white blood cell count appeared to be related to EGF and TGF-β levels. VEGF levels showed no relation to the haematological parameters considered. Platelet counts were not related to GF level in either CB or PB., Discussion: The GF content in the two blood sources was different, with CB containing larger amounts. Each GF selectively regulates cellular processes involved in corneal healing, so the use of PB or CB should be targeted to supply specific GF on the basis of the type and severity of the keratopathy.

The use of human albumin is common in hepatology since international scientific societies support its administration to treat or prevent severe complications of cirrhosis, such as the prevention of post-paracentesis circulatory dysfunction after large-volume paracentesis and renal failure induced by spontaneous bacterial peritonitis, and the treatment of hepatorenal syndrome in association with vasoconstrictors. However, these indications are often disregarded, mainly because the high cost of human albumin leads health authorities and hospital administrations to restrict its use. On the other hand, physicians often prescribe human albumin in patients with advanced cirrhosis for indications that are not supported by solid scientific evidence and/or are still under investigation in clinical trials.In order to implement appropriate prescription of human albumin and to avoid its futile use, the Italian Association for the Study of the Liver (AISF) and the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) nominated a panel of experts, who reviewed the available clinical literature and produced practical clinical recommendations for the use of human albumin in patients with cirrhosis.

Background: In 2001, the criteria for blood donor eligibility in Italy were modified by a ministerial decree from a permanent deferral for "men who have sex with men" to an individual risk assessment of sexual behaviours. The aim of this study was to evaluate the impact of this change in donor screening criteria on the human immunodeficiency virus epidemic among blood donors in Italy., Materials and Methods: We used the data obtained from the Italian blood donor epidemiological surveillance system. We compared data collected in 2009 and 2010, when the individual risk assessment policy was applied, with data collected in 1999 when permanent deferral was applied for men who have sex with men based on a declaration of sexual orientation. We evaluated the change over time in the relative proportion of HIV antibody-positive donors who likely acquired the infection from men who have sex with men vs heterosexual sexual exposure; the relative risk was calculated using 1999 as the reference year., Results: In all 3 years, the majority of HIV antibody-positive donors reported sexual exposure as a risk factor for HIV infection; this proportion increased over time, although not statistically significantly. Heterosexuals always accounted for at least 40% of all HIV antibody-positive cases. The rate of HIV antibody-positive donors increased similarly in men who have sex with men and heterosexuals; specifically, the rate of HIV antibody-positive cases per 100,000 donors was more than 2-fold higher among men who have sex with men in 2009-2010 than in 1999 (2009-2010 vs 1999, RR =2.8; P =0.06), and that among heterosexuals was 1.5 fold higher (P =0.18)., Discussion: When comparing the period before (1999) and after (2009-2010), the implementation of the individual risk assessment policy in 2001, no significant increase in the proportion of men who have sex with men compared to heterosexuals was observed among HIV antibody-positive blood donors, suggesting that the change in donor deferral policy did not lead to a disproportionate increase of HIV-seropositive men who have sex with men.

Background: A prospective, 1-year study was performed among Italian first-time, volunteer blood donors, who account for 12% of all donations, in order to assess the frequency and serological patterns of hepatitis B virus infection and the presence of occult infection., Materials and Methods: Consecutive donors (n=31,190) from 21 blood transfusion centres, from age classes not subjected to universal HBV vaccination, were tested for HBsAg and anti-HBc by commercial immunoassays. Other HBV serological markers were searched for and qualitative and quantitative assessments of HBV-DNA were made in HBsAg and/or anti-HBc-positive individuals., Results: Of the 31,190 donors studied, 100 (0.32%) were positive for both HBsAg and anti-HBc, 2 for HBsAg (0.01%) alone, and 2,593 (8.3%) for anti-HBc. Of these last, 86.7% were also positive for anti-HBs (with or without anti-HBe), 2.9% were positive for anti-HBe without anti-HBs and 10.4% had no other HBV markers (anti-HBc alone). A general north-south increasing gradient of HBV prevalence was observed. Circulating HBV-DNA was found in 96.8% of HBsAg-positive subjects as compared to 0.55% (12/2,186) of anti-HBc-positive/HBsAg-negative subjects, with higher frequencies among anti-HBs-negative than among anti-HBs-positive ones (1.68% vs. 0.37%; p <0.01) and among the 57 cases positive for both anti-HBc and anti-HBe (7%). HBV-DNA levels were significantly higher in HBsAg-positive subjects than in HBsAg-negative ones (median: 456 IU/mL vs. 38 IU/mL)., Conclusions: The prevalence of HBV infection among Italian first-time blood donors is much lower than in the past. The presence of occult infections in this group was confirmed (frequency: 1 in 2,599), supporting the hypothesis of long-term persistence of HBV infection after clearance of HBsAg. HBsAg and nucleic acid amplification testing for blood screening and vaccination against HBV are crucial in order to further reduce the risk of transfusion-transmitted HBV towards zero.

Introduction: Selecting units of rare blood for transfusion to patients with complex immunisation is one of the most critical processes of a Transfusion Centre. In January 2005 the 'Rare Blood Components Bank - Reference Centre of the Region of Lombardy' w as established with the following goals: 1) identifying regional rare blood donors; 2) creating a regional registry of rare donors; 3) organising a regional bank of liquid and frozen rare blood units; 4) setting up a regional Immunohaematology Reference Laboratory (IRL) to type donors and resolve complex cases., Methods: The key elements in establishing the Bank were periodic meetings organised by the directors and representatives of the regional Departments of Transfusion Medicine and Haematology (DTMH) and the institution of three working groups (informatics, regulations, finance)., Results: The regional IRL was set up, the relevant operating procedures were distributed region-wide, software features were defined and later validated upon activation, and the funds assigned were allocated to various cost items. The number and characteristics of the donors to be typed were identified and 14 regional DTMHs started to send samples. Overall, 20,714 donors were typed, for a total of 258,003 typings, and 2,880 rare donors were identified. Of these, 97% were rare donors because of combinations of antigens (2,139 negative for the S antigen and 659 negative for the s antigen) and 3% (n=82) because they were negative for high-frequency antigens. In the first 2 years of activity, the IRL carried out investigations of 140 complex cases referred from other Centres and distributed 2,024 units with rare phenotypes to 142 patients., Conclusions: The main goal achieved in the first 24 months from the start of the project was to set up a regional network able to meet the transfusion needs of patients with complex immunisation.

Introduction: The Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) carried out a survey on the current use of anti-D immunoprophylaxis (IP) in Italy, on its ways of use and on the impact that it has had on decreasing haemolytic disease of the newborn (HDN), due to maternal-foetal incompatibility for the D antigen., Materials and Methods: The survey was carried out using a questionnaire prepared by the Working Group established for this purpose by the SIMTI. The questions were divided into five groups: the ways of carrying out IP, evaluation of foetal-maternal haemorrhage, serological tests after IP, the current incidence of HDN, and data on exchange transfusions., Results: Data were obtained from 69 Transfusion Services (TS). Four of these give IP antenatally, whereas in the remaining cases IP is given after birth. Almost all the TS evaluate the amount of foetal-maternal haemorrhage in order to give additional doses of anti-D IgG, with the most widely used method being the Kleihauer-Betke test. Data were collected from 176,010 pregnancies: 18,639 were D-negative women, of whom 18,440 were not immunised. There were 136 cases of HDN with anti-D antibodies, and 39 of these required exchange transfusions (ET). Furthermore, there were 1,535 pregnant women with anti-A and/or anti-B IgG, which were clinically significant in 83 and required ET in 37. Finally, 40 women had antibodies, directly related to the pregnancy, against antigens other than D (in eight of these cases ET was necessary)., Conclusions: The survey carried out by SIMTI was able to give a sufficiently full and accurate picture of current Italian practices concerning the use and ways of use of anti-D IP in pregnancy and the puerperum, as well as the incidence and characteristics of HDN. Furthermore, this survey was the basis for guidelines on the management of HDN, produced by SIMTI in collaboration with the Italian Society of Obstetricians and Gynaecologists.