Safety Of Blood Products Research Articles

Seroprevalence and diagnosis of HIV, HBV, HCV and syphilis infections among blood donors.

Blood transfusion is one of the most important therapeutic options of life-saving intervention for recipients who are in diseased or non-diseased conditions with severe blood loss. However, it is associated with certain risks which can lead to adverse consequences that may cause acute or delayed complications and bring the risk of transfusion-transmissible infections including HIV, Hepatitis B & C and Syphilis. So, there might be a fatal risk instead of life saving. This paper aims to provide a comprehensive and reliable tabulation of available data on seroprevalence and diagnosis of HIV, HBV, HCV and Syphilis infections among blood donors. We searched studies reporting the prevalence rate of HIV, HBV, HCV and Syphilis infections among blood donors that were published between October 2009 and June 2016, using databases of PubMed, Scopus, MEDLINE, Elsevier, ScienceDirect, EBSCO, Google Scholar, EMBASE, and Web of Science with keywords: ``Hepatitis C Virus'', ``Hepatitis B Virus'', ``HIV'', ``Syphilis'', ``Seroprevalence'', and ``blood donor''. The seroprevalence of HBV and HCV was highest in African countries as compared to others continents, predominantly the West African region with a range of 10.0% to 14.96% and 1.5% to 8.69%, respectively, while the overall seropositivity of HIV and syphilis infection show a significant declining pattern through successive years globally, even though relatively higher prevalence rate was observed among older age and those with low level of education. There is a problem during selection, diagnoses and screening process in developing nations primarily due to shortage of sensitive screening test kits, highly qualified human resource and lack of proper standard operating procedures and hence, the safety of blood and blood products are the primary threats in the region. Proper clinical diagnosis and screening method should be applied during blood donation and therefore, all the donated blood should be screened properly for transfusion-transmitted infections.

Blood Transfusions in Dogs and Cats Receiving Hemodialysis: 230 Cases (June 1997-September 2012).

BackgroundMultiple factors exist that contribute to anemia in dogs and cats receiving hemodialysis, can necessitate transfusion.ObjectivesTo describe blood product usage in dogs and cats with acute and chronic kidney disease that were treated with intermittent hemodialysis to determine risk factors associated with the requirement for blood product transfusion.Animals83 cats and 147 dogs undergoing renal replacement therapy at the Animal Medical Center for acute or chronic kidney disease.MethodsRetrospective medical record review of all dogs and cats receiving renal replacement therapy for kidney disease, from June 1997 through September 2012.ResultsBlood products (whole blood, packed RBCs, or stromal‐free hemoglobin) were administered to 87% of cats and 32% of dogs. The number of dialysis treatments was associated with the requirement for transfusion in cats (adjusted OR 2.21, 95% CI 1.13, 4.32), but not in dogs (adjusted OR 0.98, 95% CI 0.95, 1.03). Administration of a blood product was associated with a higher likelihood of death in dogs (OR 3.198, 95% CI 1.352, 7.565; P = .0098), but not in cats (OR 1.527, 95% CI 0.5404, 4.317, P = .2).Conclusions and Clinical ImportanceVeterinary hospitals with a hemodialysis unit should have reliable and rapid access to safe blood products in order to meet the needs of dogs and cats receiving dialysis.

Identification of potential protein quality markers in pathogen inactivated and gamma-irradiated red cell concentrates.

Post-collection manipulations (PCMs) aim to increase blood product safety. However, PCMs improve safety at a cost to quality, causing elevated hemolysis. As hemolysis is linked to red blood cell membrane integrity, a quantitative proteomics approach was employed to assess membrane proteome alterations induced by PCMs. Three ABO-matched whole blood (WB) units were pooled-and-split into three identical units. One WB unit was treated with riboflavin/ultraviolet illumination prior to red cell concentrate (RCC) production (RCCWB* ). Two WB units were produced into RCC; one was gamma-irradiated (RCCγ ) and the other was left untreated as control (RCCØ ). In vitro quality parameters were measured during storage. Membrane protein profiles of RCCØ , RCCγ , and RCCWB* were assessed on selected hemoglobin-depleted membrane fractions using a quantitative proteomics approach based on iTRAQ. Quantitative proteomic analysis identified 100 proteins at the membrane, with seven unique proteins exhibiting significant changes in RCCWB* at day 28 of storage. Membrane peroxiredoxin-2, catalase, and proteasome levels demonstrated robust negative correlation with percentage hemolysis. Overall, the in vitro parameters and alterations of membrane protein profiles indicated that pathogen inactivation treatment impacts RCC quality more severely than gamma-irradiation and that it may induce damage through a predominately oxidative mechanism.

Knowledge, attitude, and practice regarding voluntary blood donation among adult residents of Harar town, Eastern Ethiopia: a community-based study.

BackgroundThe availability of safe blood and blood products is a critical factor in improving health care. In Ethiopia, lack of voluntary blood donors is a major challenge. This could be due to low community knowledge, unfavorable attitude, and poor donation practice regarding voluntary blood donation. Thus, the aim of this study was to assess community knowledge, attitude, and practice regarding voluntary blood donation among adults in Harar town, Ethiopia.Materials and methodsA community-based cross-sectional study was conducted from July 1 to July 31, 2015. A total of 845 adults were randomly selected and interviewed using a pretested, structured questionnaire. Six trained data collectors conducted a face-to-face interview. Data were entered into EpiData Version 3 and analyzed using STATA Version 11.ResultsComprehensive knowledge of the study participants toward voluntary blood donation was 43.5%. Multivariable logistic regression demonstrated that male sex (adjusted odds ratio [AOR] = 1.69, 95% confidence interval [CI]: 1.19–2.39), age (31–45 years; AOR = 0.50, 95% CI: 0.34–0.74) and >45 years (AOR = 0.60, 95% CI: 0.38–0.95), and higher education (AOR = 15.34, 95% CI: 5.01–46.91) were significantly associated with comprehensive knowledge about voluntary blood donation. A total of 278 (32.9%) study participants had positive attitude toward voluntary blood donation. College graduates (AOR = 13.05, 95% CI: 4.12–41.29) were significantly associated with positive attitude toward voluntary blood donation. Only 191 (22.6%) subjects had ever donated blood. However, the proportion of study participants who donated blood voluntarily with good knowledge about voluntary blood donation was significantly lower than the study participants who donated blood voluntarily with low knowledge (X2 = 6.1746, P = 0.013).ConclusionThis study showed an inauspicious attitude toward blood donation and poor blood donation practices. Subjects with good comprehensive knowledge about voluntary blood donation were less likely to donate blood voluntarily compared to those with lower comprehensive knowledge about voluntary blood donation.

Strengthening Health Systems Through International Blood Product Sharing Agreements.

Blood products are critical to the success of both routine healthcare delivery and emergency response efforts. Ensuring the safety and availability of blood products presents nations with considerable collection, screening, and distribution challenges that are often exacerbated by public health crises, particularly mass-casualty events involving traumatic injuries. However, recent outbreaks of Ebola and Zika virus disease have also illustrated the importance of securing blood product supplies during ongoing infectious disease emergencies. The United States and other nations should consider enhancing existing mechanisms for sharing medical countermeasures by creating formal agreements for sharing blood products during public health emergencies.

Existing and recommended legislative framework for a national blood transfusion policy

Blood transfusion contributes to saving millions of lives every year, improves life expectancy, and the quality of life of patients suffering from life-threatening conditions and supports complex medical and surgical procedures. Every country should put in place policies, a legislative framework, systems and structures to ensure the safety, quality, accessibility, and timely availability of blood and blood products to meet the needs of all patients who require transfusion. However, there are numerous situations, particularly in the less developed world, where these prerequisites have barely been implemented. A literature search was done on matching combinations of legislation, regulation, legislation framework, with blood and blood transfusion, which resulted in almost exclusively references with respect to national and international legislation. The Ministry of Health should provide effective leadership and governance in developing a national blood system that is fully integrated into the health-care system. Essential functions of a national blood system include policy formulation, a legislation framework spelling out the principles and boundaries, standard setting, strategic and operational planning, provision of resources and national coordination, and management to ensure an adequate supply of blood and blood products and safe clinical transfusion. The structure of the national blood system will depend on the organization and level of development of the health-care system. However, all critical activities within a national blood system should be coordinated nationally to promote uniform standards, economies-of-scale, consistency in quality and safety of blood and blood products. and best transfusion practices. Keys are formulation and oversight of the implementation of the national blood policy and strategic plan; defining the roles, responsibilities, and accountability of institutions; and setting national standards for blood and blood products, services, processes, and systems; defining requirements for the registration, licensing, and operation.

Methemoglobin levels among malaria parasite-infected blood donors in Nnewi, Southeastern, Nigeria

Background: Safety of blood and blood products is of immense concern in transfusion medicine. Malaria parasite (MP) which is known to be endemic in the tropics has been shown to disrupt hemoglobin molecule converting it to nonfunctional methemoglobin which is unable to transport oxygen effectively. Objective: This study was aimed at determining the prevalence of malaria parasitemia and methemoglobin level among blood donors attending Nnamdi Azikiwe University Teaching Hospital (NAUTH). Subjects and Methods: A total of 100 apparently healthy blood donors aged 18-60 years were recruited and tested for MP, methemoglobin level, and packed cell volume (PCV), after obtaining ethical approval from the Ethics Committee of NAUTH and informed consent of the participants. Methemoglobin was assayed by cyanmethemoglobin method, and MP was tested using thick and thin blood film and PCV by microhematocrit method. Statistical Package for Social Sciences (SPSS) version 20 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Results: Among the 100 blood donors screened, 75 of the participants representing 75% were positive for MP and 25 representing 25% tested negative. Plasmodium falciparum was responsible for all cases of parasitemia. The mean values of methemoglobin were significantly higher in asymptomatic MP infected blood donors than in noninfected donors, while PCV was significantly reduced in malaria infected donors compared to noninfected donors (P < 0.05). Conclusion: This study identified a high rate of malaria parasitemia in blood donors and an elevated methemoglobin level in asymptomatic MP infected donors. Screening of blood donors for MP is advocated and exclusion of infected donors may be necessary.

Administration Safety of Blood Products - Lessons Learned from a National Registry for Transfusion and Hemotherapy Practice

Background: Compared to blood component safety, the administration of blood may not be as safe as intended. The German Interdisciplinary Task Force for Clinical Hemotherapy (IAKH) specialized registry for administration errors of blood products was chosen for a detailed analysis of reports. Methods: Voluntarily submitted critical incident reports (n = 138) from 2009 to 2013 were analyzed. Results: Incidents occurred in the operation room (34.1%), in the ICU (25.2%), and in the peripheral ward (18.5%). Procedural steps with errors were administration to the patient (27.2%), indication and blood order (17.1%), patient identification (17.1%), and blood sample withdrawal and tube labeling (18.0%). Bedside testing (BST) of blood groups avoided errors in only 2.6%. Associated factors were routine work conditions (66%), communication error (36%), emergency case (26%), night or weekend team (39%), untrained personnel (19%). Recommendations addressed process and quality (n = 479) as well as structure quality (n = 314). In 189 instances, an IT solution would have helped to avoid the error. Conclusions: The administration process is prone to errors at the patient assessment for the need to transfuse and the application of blood products to patients. BST is only detecting a minority of handling errors. According to the expert recommendations for practice improvement, the potential to improve transfusion safety by a technical solution is considerable.

Prevalence of transfusion transmissible infections in blood donors of Pakistan.

BackgroundTransfusion-transmitted infections threaten the safety of patients requiring blood transfusion, which in turn imposes serious challenges for the availability of safe blood products that are still affordable in health care systems with limited resources. The aim of the study was to determine the prevalence of transfusion-transmitted infections in blood donors and to evaluate the demographic characteristics of reactive and non-reactive blood donors.MethodsA prospective cohort study was conducted at our institute in Karachi, Pakistan. Donors were required to fill a detailed questionnaire and were screened for Hepatitis B, Hepatitis C, Human immunodeficiency viruses, Syphilis and Malaria by ELISA and thick film (malaria).ResultsOf the 16,602 blood donors, 16,557 were males and 45 females (mean age 28.6 ± 2). Nine hundred and seventy three (5.8%) donations were reactive in any screening assay, with 58 (0.35%) donations reacting in more than one assay. The prevalence of Hepatitis B, Hepatitis C, Human immunodeficiency viruses, Syphilis and Malaria was found to be 1.84, 1.7, 0.04, 2.1 and 0.07% respectively. Characteristics among the infections were evaluated and it was found that unmarried donors had a higher chance to be infected by Hepatitis B virus and Syphilis as compared to the other infections. On the other hand, construction workers and married donors were at more risk to be infected by Syphilis rather than the other infections. In case of co-infections, personnel with different occupations and marital status were infected by more than one pathogen.ConclusionA substantial percentage of the blood donor’s harbored transfusion-transmitted infections. Prevention of TTIs should be the main goal right now. There is a need for stringent selection of blood donors with the emphasis on getting voluntary donations and comprehensive screening of donor’s blood for TTIs using standard methods to ensure the safety of blood recipient.

Inactivation of Middle East respiratory syndrome coronavirus (MERS-CoV) in plasma products using a riboflavin-based and ultraviolet light-based photochemical treatment.

BACKGROUNDMiddle East respiratory syndrome coronavirus (MERS‐CoV) has been identified as a potential threat to the safety of blood products. The Mirasol Pathogen Reduction Technology System uses riboflavin and ultraviolet (UV) light to render blood‐borne pathogens noninfectious while maintaining blood product quality. Here, we report on the efficacy of riboflavin and UV light against MERS‐CoV when tested in human plasma.STUDY DESIGN AND METHODSMERS‐CoV (EMC strain) was used to inoculate plasma units that then underwent treatment with riboflavin and UV light. The infectious titers of MERS‐CoV in the samples before and after treatment were determined by plaque assay on Vero cells. The treatments were initially performed in triplicate using pooled plasma (n = 3) and then repeated using individual plasma units (n = 6).RESULTSIn both studies, riboflavin and UV light reduced the infectious titer of MERS‐CoV below the limit of detection. The mean log reductions in the viral titers were ≥4.07 and ≥4.42 for the pooled and individual donor plasma, respectively.CONCLUSIONRiboflavin and UV light effectively reduced the titer of MERS‐CoV in human plasma products to below the limit of detection, suggesting that the treatment process may reduce the risk of transfusion transmission of MERS‐CoV.

The infectious disease blood safety risk of Australian hemochromatosis donations.

It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile.

International validation of a dithiothreitol (DTT)-based method to resolve the daratumumab interference with blood compatibility testing.

Daratumumab (DARA) consistently interferes with routine blood bank serologic testing by directly binding to CD38 expressed on reagent red blood cells (RBCs). Treating RBCs with dithiothreitol (DTT) eliminates the DARA interference. We conducted an international, multicenter, blinded study aimed at validating the DTT method for use by blood bank laboratories worldwide. Paired plasma sample unknowns were sent to 25 participating blood bank laboratories. Sample 1 was spiked with DARA only (10µg/mL), and Sample 2 with DARA plus a clinically significant RBC antibody (anti-D [n=6], anti-Fya [n=9], or anti-s [n=10]). Sites were instructed to perform an antibody screen with and without DTT-treated RBCs and to use a DTT-treated RBC panel for antibody identification. Qualitative data about the DTT method were collected by online survey. The primary outcome was the proportion of study sites able to identify the antibody unknown in the presence of DARA. All sites observed the DARA interference with the antibody screen. The DARA interference was seen with all testing methods (gel, tube, or solid phase). Using the DTT method, 25 of 25 sites (100%) successfully identified the antibody unknown in the presence of DARA. Feedback on the DTT method was positive, with 17 of 19 (90%) sites responding to the survey indicating that they planned to use the DTT method to test clinical samples from DARA-treated patients. The DTT method is robust and reproducible and can be implemented by transfusion services worldwide to help provide safe blood products to patients treated with DARA.

Army Air Ambulance Blood Product Program in the Combat Zone and Challenges to Best Practices.

Identify challenges and best practices in the development of an austere air ambulance transfusion program. A search of PubMed using combinations of the key terms 'prehospital,' 'blood product,' 'red blood cells,' 'damage control resuscitation,' 'transfusion,' 'air ambulance,' 'medical evacuation,' and 'medevac' yielded 196 articles for further analysis, with 14 articles suitable for addressing the background of prehospital transfusion within a helicopter. Retrospective analysis of unclassified briefs, after action reports, and procedures was also undertaken along with interview of subject matter experts. The initial series of 15 transfusions were discussed telephonically among flight crew, trauma surgeons, and lab specialists. Review of Joint Theater System data was readily available for 84 U.S. Army air ambulance transfusions between May-December 2012, with December marking the redeployment of the 25(th) Combat Aviation Brigade. Standardized implementation enabled safe blood product administration for 84 causalities from May-December 2012 without blood product shortage, expiration, or transfusion reaction. Challenges included developing transfusion competency, achieving high quality blood support, countering the potential for anti-U.S. sentiment, and diversity in coalition transfusion practices. Blood product administration aboard the air ambulance is logistically complex, requiring blood bank integration. Repetitive training enabled emergency medical technicians (EMTs) with basic medical training to safely perform transfusion in accordance with clinical operating guidelines. In the austere environment, logistic factors are significant challenges and political sensitivities are important considerations. Best practices may facilitate new en route transfusion programs. Powell-Dunford N, Quesada JF, Gross KR, Shackelford SA. Army air ambulance blood product program in the combat zone and challenges to best practices. Aerosp Med Hum Perform. 2016; 87(8):728-734.

Past, present and forecast of transfusion medicine: What has changed and what is expected to change?

Blood transfusion is the second most used medical procedures in health care systems worldwide. Over the last few decades, significant changes have been evolved in transfusion medicine practices. These changes were mainly needed to increase safety, efficacy, and availability of blood products as well as reduce recipients' unnecessary exposure to allogeneic blood. Blood products collection, processing, and storage as well as transfusion practices throughout all patient populations were the main stream of these changes. Health care systems across the world have adopted some or most of these changes to reduce transfusion risks, to improve overall patients' outcome, and to reduce health care costs. In this article, we are going to present and discuss some of these recent modifications and their impact on patients' safety.

Protein translation occurs in platelet concentrates despite riboflavin/UV light pathogen inactivation treatment.

Pathogen inactivation technologies (PITs) were introduced into blood banking to further improve the safety of blood products. However, the UV light used in PITs to terminate pathogen growth might alter the functionality of the cells in the blood product as well as the protein profile of the blood components. This study employed proteomic approaches to assess changes in the platelet proteome and translatome. Apheresis-derived platelet concentrates treated with riboflavin/UV light or untreated controls were analyzed throughout blood bank storage by quantitative proteomics using iTRAQ and puromycin-associated nascent chain (PUNCH) proteomics. Quantitative proteomic analysis identified 408 individual proteins including 26 unique proteins that changed in the treated arm during storage. Proteomic results were confirmed using immunoblot analyses and results suggested a translational control of the protein expression profile. PUNCH proteomic analysis of day 7 samples from illuminated units identified 52 unique platelet proteins that incorporated puromycin, including proteins involved in the cytoskeleton, metabolism, and signaling. This study demonstrates for the first time that platelets can synthesize proteins despite the riboflavin and UV treatment and suggests that platelets may possess a mechanism to protect their mRNA from damage by the PI treatment.

Update on Laboratory Testing for Diagnosing HIV Infection

Generally, laboratory testing for human immunodeficiency virus (HIV) is done for three reasons: for individual diagnosis and clinical management; to ensure the safety of blood or tissue products; and for public health surveillance. Many HIV-infected patients are unaware of their infections. The early diagnosis of infection is critical for medical and public health reasons. Its diagnosis is a two-step process that requires the sequential use of a highly sensitive screening test, followed by a highly specific confirmatory test. HIV-testing technology continues to evolve, with various tests currently available. This article reviews the current status of and recent advances in HIV testing. (Korean J Med 2016;90:469-473)

Genotyping of 22 blood group antigen polymorphisms and establishing a national recipient registry in the Korean population.

It is often difficult for standard blood banks in Korea to supply adequate amounts of blood for patients with rare phenotype. Moreover, the definition of a blood in need is ambiguous, and much remains to be learned. In this study, we determined the prevalence of various red blood cell (RBC) antigens from a donor viewpoint and estimated the demand for specific antigen-negative blood from a patient viewpoint. Our data will aid the establishment of a Rare Blood Program in Korea (KRBP). RBC genotyping of 419 blood donors was performed using a Lifecodes RBC/RBC-R typing kit (Immucor, Norcross, GA). A national recipient registry website has been established. Each hospital-based blood bank voluntarily enters data on antibodies detected and identified and the outcomes of specific antigen testing. We calculated the availabilities of specific antigen-negative blood components based on these registry data and predicted the prevalence of RBC antigens via RBC genotyping. The prevalences of various RBC antigens in the D-negative population were determined for the first time, and the Cartwright, Scianna, Dombrock, Colton, Landsteiner-Wiener, Cromer, and Knops blood group systems were identified. The availabilities of specific antigen-negative units differed when calculations were based on serotyping or genotyping, especially in the D-negative group. Data on the prevalences of various blood antigens are essential for estimating the availabilities of blood components that are appropriate for use by patients expressing relevant antibodies. Then, blood banks would be able to efficiently supply safe blood products.

Plasma and plasma-derived medicinal product self-sufficiency: the Italian case.

According to the World Health Organization, “self-sufficiency in safe blood and blood products based on voluntary non-remunerated blood donation (VNRBD) means that the national needs of patients for safe blood and blood products, as assessed within the framework of the National Health Service (NHS), are met in a timely manner, that patients have equitable access to transfusion services and blood products, and that these products are obtained from VNRBD of national, and where needed, of regional origin, such as from neighbouring countries”1. In Italy, the achievement of self-sufficiency of plasma-derived medicinal products (PMPs), as well as blood components, is a goal of the blood system “aimed at guaranteeing equal conditions of quality and safety of transfusion therapy to all citizens”, as set out by the main regulatory reference2. Self-sufficiency is recognised as a role of “national, supra-regional, supra-local indivisible interest of the National Health Service” whose achievement is entrusted to the contributions of the regional health authorities. In order to attain this strategic goal, the Ministry of Health is responsible for defining an annual national programme for self-sufficiency aimed at identifying historical usages, real demand, necessary production levels, resources, funding system criteria, interregional PMP exchanges, import and export levels3–5. Moreover, according to current legislative provisions6,7, a special decree must be adopted for defining the “program for the development of plasma collection in blood services and blood collection units, as well as the promotion of an appropriate and rational use of plasma-derived medicinal products”. In addition, national plasma derives from voluntary, periodic, responsible, anonymous and non-remunerated donations2. Regions and Autonomous Provinces (APs) (henceforth referred to as “Regions”), individually or in association, send the plasma collected by blood establishments (BE) to Kedrion Biopharma (Kedrion SpA, Castelvecchio Pascoli, Lucca, Italy), which, at the moment, is the only manufacturer authorised under a toll fractionation agreement. The latter has the capacity to produce at least the following PMPs: human albumin solution (albumin), polyvalent immunoglobulin (for intravascular administration, IVIG), plasma-derived factor VIII concentrates (pdFVIII), plasma-derived factor IX concentrates (pdFIX), prothrombin complex concentrates (PCCs), and antithrombin (AT). However, Regions remain owners of the plasma sent for fractionation, as well as of PMPs manufactured and of the residual raw material, including discards. Therefore, self-sufficiency strongly depends on the capacity of regional health systems and the national blood system to ensure the satisfaction of patients’ needs using all products obtained by the manufacturing of national plasma within the toll fractionation agreements between Regions and fractionators thus reducing supplies from the pharmaceutical market8–10. However, also the appropriate clinical use of plasma11 and of PMPs plays a key role in self-sufficiency. The aim of the present paper is to address the issue of PMPs self-sufficiency in Italy in 2011.

Treatment of blood with a pathogen reduction technology using ultraviolet light and riboflavin inactivates Ebola virus in vitro.

Transfusion of plasma from recovered patients after Ebolavirus (EBOV) infection, typically called "convalescent plasma," is an effective treatment for active disease available in endemic areas, but carries the risk of introducing other pathogens, including other strains of EBOV. A pathogen reduction technology using ultraviolet light and riboflavin (UV+RB) is effective against multiple enveloped, negative-sense, single-stranded RNA viruses that are similar in structure to EBOV. We hypothesized that UV+RB is effective against EBOV in blood products without activating complement or reducing protective immunoglobulin titers that are important for the treatment of Ebola virus disease (EVD). Four in vitro experiments were conducted to evaluate effects of UV+RB on green fluorescent protein EBOV (EBOV-GFP), wild-type EBOV in serum, and whole blood, respectively, and on immunoglobulins and complement in plasma. Initial titers for Experiments 1 to 3 were 4.21 log GFP units/mL, 4.96 log infectious units/mL, and 4.23 log plaque-forming units/mL. Conditions tested in the first three experiments included the following: 1-EBOV-GFP plus UV+RB; 2-EBOV-GFP plus RB only; 3-EBOV-GFP plus UV only; 4-EBOV-GFP without RB or UV; 5-virus-free control plus UV only; and 6-virus-free control without RB or UV. UV+RB reduced EBOV titers to nondetectable levels in both nonhuman primate serum (≥2.8- to 3.2-log reduction) and human whole blood (≥3.0-log reduction) without decreasing protective antibody titers in human plasma. Our in vitro results demonstrate that the UV+RB treatment efficiently reduces EBOV titers to below limits of detection in both serum and whole blood. In vivo testing to determine whether UV+RB can improve convalescent blood product safety is indicated.

Evaluation of the Sensitivity and Specificity of Use of Glucose and pH for Bacterial Screening of Platelet Concentrates Compared to the Bact/Alert.

Bacterial contamination of blood components is the major infectious risk in transfusion medicine. Since platelets should be stored at room temperature that makes them an excellent growth medium for bacteria; it is mentioned as a major problem in transfusion medicine. Transfusion risk of a bacterial contaminated platelet concentrate is higher than viral pathogen such as HIV, HBV, HCV and HTLV. The objective of this study was to evaluation of the sensitivity and specificity of use of glucose and pH for bacterial screening of platelet concentrates compared to the Bact/Alert. 1332 platelet concentrates were screened by the Bact/Alert system for aerobic and anaerobic bacterial contamination. Bacterial contamination was also evaluated by using urine reagent strips (Multistix10 SG Bayer) and culture methods. Moreover PH screening with a pH meter (Metrohm 744 Swiss) and glucose was also used for detection of bacterial contamination. The rate of bacterial contamination detected by the Bact/Alert system in platelet concentrates was 25 in 1332 (1.9%). It contained 15 (1.1%) for aerobic bacteria and 10 (.8%) for anaerobic bacteria. 226 of 1332 were considered as containing bacteria by using urine reagent strips. Six of the 226 units were also positive by the Bact/Alert system. Three of those units were culture positive for aerobic bacteria and three for anaerobic. The result of platelet concentrates that underwent pH screening by use of pH meter and a pH portion of urine reagent strips was the same. The sensitivity and specificity of considering glucose alone for detection of bacterial contamination were 12 and 98% respectively. For pH alone, these were 24 and 83%. For glucose and/or pH, these were 24 and 83%; and for combination of glucose and pH, these were 12 and 98%. Our results showed use of glucose/pH strips would improve the safety of blood products and should be encouraged.