Improvements In Blood Safety Research Articles

Improving blood safety and availability: a collective mindfulness perspective in the supply chain

PurposeMaintaining a safe and available supply of blood requires a mindfully coordinated supply chain (SC) and is fundamental to the effective operation of health systems across the world. This study investigates how blood supply chain (BSC) actors demonstrate collective mindfulness (CM) principles in their operations and how these demonstrations lead to improvements in blood safety and availability (BSA) in different operational contexts.Design/methodology/approachSix case studies drawn from two contrasting BSCs, the UK and Indonesia, which differ in structure and regulation are investigated in this research. Qualitative data are collected and analysed using template analysis.FindingsThe cases reveal how the CM principles are demonstrated in the supply chain context in a range of operational conditions and their impact on BSA. The BSC actors in the more centralised and tightly regulated cases display more behaviours consistent with more of the CM principles over a greater range of operational conditions compared to those in the more decentralised and loosely regulated cases. As such, more improvements in BSA are found in the former compared to the latter cases.Originality/valueThis paper is considered the first to investigate the demonstration of CM principles at the SC as opposed to the single organisational level. It proposes an alternative approach to understanding and evaluating reliability performance using behavioural rather than statistical principles.

Improvement of Blood Processing and Safety by Automation and Pathogen Reduction Technology

Introduction: The objective of the present study was to describe the experience of the Blood and Tissues Bank of Aragon with the Reveos® Automated Blood Processing System and Mirasol® Pathogen Reduction Technology (PRT) System, comparing retrospectively routine quality data obtained in two different observation periods. Methods: Comparing quality data encompassing 6,525 blood components from the period 2007–2012, when the semi-automated buffy coat method was used in routine, with 6,553 quality data from the period 2014–2019, when the Reveos system and subsequently the Mirasol system were implemented in routine. Results: Moving from buffy coat to Reveos led to decreased discard rates of whole blood units (1.2 to 0.1%), increased hemoglobin content (48.1 ± 7.6 to 55.4 ± 6.6 g/unit), and hematocrit (58.9 ± 6.5% to 60.0 ± 4.9%) in red blood cell concentrates. Platelet concentrates (PCs) in both periods had similar yields (3.5 ×10¹¹). Whereas in the earlier period, PCs resulted from pooling 5 buffy coats, in the second period 25% of PCs were prepared from 4 interim platelet units. The mean level of factor VIII in plasma was significantly higher with Reveos (92.8 vs. 97.3 IU). Mirasol PRT treatment of PCs reduced expiry rates to 1.2% in 2019. One septic transmission was reported with a non-PRT treated PCs, but none with PRT-treated PCs. Conclusion: Automation contributed to standardization, efficiency, and improvement of blood processing. Released resources enabled the effortless implementation of PRT. The combination of both technologies guaranteed the self-sufficiency and improvement of blood safety.

Blood transfusion safety in the country of Georgia: collateral benefit from a national hepatitis C elimination program.

In April 2015, the government of Georgia (country) initiated the world's first national hepatitis C elimination program. An analysis of blood donor infectious screening data was conducted to inform a strategic plan to advance blood transfusion safety in Georgia. Descriptive analysis of blood donation records (2015-2017) was performed to elucidate differences in demographics, donor type, remuneration status, and seroprevalence for infectious markers (hepatitis C virus antibody [anti-HCV], human immunodeficiency virus [HIV], hepatitis B virus surface antigen [HBsAg], and Treponema pallidum). For regression analysis, final models included all variables associated with the outcome in bivariate analysis (chi-square) with a p value of less than 0.05. During 2015 to 2017, there were 251,428 donations in Georgia, representing 112,093 unique donors; 68.5% were from male donors, and 51.2% of donors were paid or replacement (friends or family of intended recipient). The overall seroprevalence significantly declined from 2015 to 2017 for anti-HCV (2.3%-1.4%), HBsAg (1.5%-1.1%), and T. pallidum (1.1%-0.7%) [p < 0.0001]; the decline was not significant for HIV (0.2%-0.1%). Only 41.0% of anti-HCV seropositive donors underwent additional testing to confirm viremia. Infectious marker seroprevalence varied by age, sex, and geography. In multivariable analysis, first-time and paid donor status were associated with seropositivity for all four infectious markers. A decline during the study period in infectious markers suggests improvement in blood safety in Georgia. Areas that need further improvement are donor recruitment, standardization of screening and diagnostic follow-up, quality assurance, and posttransfusion surveillance.

Implementation of a script for predonation interviews: impact on human immunodeficiency virus risk in South African blood donors.

The way in which the donor history questionnaire is conducted plays a crucial role in the self-disclosure of behavioral risk factors for human immunodeficiency virus (HIV) infection by prospective donors. The South African National Blood Service changed its policy on the process of donor assessment in May 2015 by implementing a compulsory interviewer script used to assess donor eligibility. A pre- and postevaluation study to determine the impact of scripted interviews on high-risk deferrals and recently acquired HIV infections. We used historical data to compare 18 months before and after the implementation of the script. We recorded a total of 3,169,656 donor presentations during the two 18-months periods, of which 52.2% (1,655,352) were made during the scripted period. A multivariable logistic regression analysis adjusting for donor and demographic characteristics found the odds of high-risk deferral to be slightly greater (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.05-1.07) during the scripted period. A separate multivariate logistic regression model, also adjusting for donor and demographic characteristics, showed that the odds of recently acquired HIV infection were significantly lower (OR, 0.88; 95% CI, 0.79-0.97) during the scripted period. This study showed that implementation of a scripted interview was associated with increased HIV risk deferral and decreased recent HIV infection. This study indicates potential improvement in blood safety with the implementation of a scripted donor interview and has relevance to blood safety in other sub-Saharan African countries.

Scaling up prevention and treatment towards the elimination of hepatitis C: a global mathematical model

SummaryBackgroundThe revolution in hepatitis C virus (HCV) treatment through the development of direct-acting antivirals (DAAs) has generated international interest in the global elimination of the disease as a public health threat. In 2017, this led WHO to establish elimination targets for 2030. We evaluated the impact of public health interventions on the global HCV epidemic and investigated whether WHO's elimination targets could be met.MethodsWe developed a dynamic transmission model of the global HCV epidemic, calibrated to 190 countries, which incorporates data on demography, people who inject drugs (PWID), current coverage of treatment and prevention programmes, natural history of the disease, HCV prevalence, and HCV-attributable mortality. We estimated the worldwide impact of scaling up interventions that reduce risk of transmission, improve access to treatment, and increase screening for HCV infection by considering six scenarios: no change made to existing levels of diagnosis or treatment; sequentially adding the following interventions: blood safety and infection control, PWID harm reduction, offering of DAAs at diagnosis, and outreach screening to increase the number diagnosed; and a scenario in which DAAs are not introduced (ie, treatment is only with pegylated interferon and oral ribavirin) to investigate the effect of DAA use. We explored the effect of varying the coverage or impact of these interventions in sensitivity analyses and also assessed the impact on the global epidemic of removing certain key countries from the package of interventions.FindingsBy 2030, interventions that reduce risk of transmission in the non-PWID population by 80% and increase coverage of harm reduction services to 40% of PWID could avert 14·1 million (95% credible interval 13·0–15·2) new infections. Offering DAAs at time of diagnosis in all countries could prevent 640 000 deaths (620 000–670 000) from cirrhosis and liver cancer. A comprehensive package of prevention, screening, and treatment interventions could avert 15·1 million (13·8–16·1) new infections and 1·5 million (1·4–1·6) cirrhosis and liver cancer deaths, corresponding to an 81% (78–82) reduction in incidence and a 61% (60–62) reduction in mortality compared with 2015 baseline. This reaches the WHO HCV incidence reduction target of 80% but is just short of the mortality reduction target of 65%, which could be reached by 2032. Reducing global burden depends upon success of prevention interventions, implemention of outreach screening, and progress made in key high-burden countries including China, India, and Pakistan.InterpretationFurther improvements in blood safety and infection control, expansion or creation of PWID harm reduction services, and extensive screening for HCV with concomitant treatment for all are necessary to reduce the burden of HCV. These findings should inform the ongoing global action to eliminate the HCV epidemic.FundingWellcome Trust.

NATSpert ID TripleH: A novel individual donor multiplex nucleic acid amplification test to reduce risk of transfusion-transmitted infections: Two-year experience of a blood bank in central India

Background: In India serological screening is mandatory for all donated blood for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) while Nucleic Acid Amplification Testing (NAT) is not a mandatory screening test. There is a risk of transfusion-transmitted infections (TTI) during window period using serology. Aims and Objectives: The aim of this study was to analyse NAT screening using an indigenously developed, Indian manufactured Individual Donor NAT (ID-NAT) and compare it with serology. Materials and Methods: All blood donations between June 2017-March 2019 were screened serologically for HBV, HCV and HIV at an Indian blood bank. Blood donations also underwent ID-NAT screening using the NATSpert ID TripleH detection assay based on real time PCR. The results were analysed to identify yield cases. Results: In the study, 30,772 blood donor samples were screened serologically out of which 214 were reactive. 30,558 serologically non-reactive blood donations and 77 randomly selected, serologically reactive blood donations were screened using NATSpert. Out of 30,635, 85 donor samples were reactive on the NATSpert which included 77 serology positive and 8 NAT yield cases. The NAT yield found was 2 each for HBV/HIV and 4 of HCV. Conclusion: The NATSpert ID TripleH offers a statistically significant advantage over EIA in ability to detect TTI in blood donors (P < 0.05, Fishers Exact Test). The NAT yield of 1:3829 was in line with other Indian studies. NATSpert assay will provide a significant improvement in blood safety and offer a cost benefit compared to the imported products.

Re-examining blood donor deferral criteria relating to injecting drug use

Background and aimsPotential Australian blood donors are deferred indefinitely if they report a history of injecting drug use (IDU), or for 12 months if they report having engaged in sexual activity with someone who might have ever injected. Given incremental improvements in blood safety, this study sought to examine whether Australia’s IDU-related eligibility criteria reflected current scientific evidence, were consistent with international best practice and, if current IDU-related policies were to be changed, how this should happen. MethodsAn expert committee was formed to review relevant literature with a focus on issues including: the epidemiology of IDU in Australia and key transfusion-transmissible infections (TTIs) among Australian people who inject drugs (PWID); and, ‘non-compliance’ among PWID regarding IDU-related blood donation guidelines. International policies relating to blood donation and IDU were also reviewed. Modelling with available data estimated the risk of TTIs remaining undetected if the Blood Service’s IDU-related guidelines were changed. ResultsVery few (<1%) Australians engage in IDU, and IDU risk practices are reported by only a minority of PWID. However, the prevalence of HCV remains high among PWID, and IDU remains a key transmission route for various TTIs. Insufficient data were available to inform appropriate estimates of cessation and relapse among Australian PWID. Modelling findings indicated that the risk of not detecting HIV becomes greater than the reference group at a threshold of non-admission of being an active PWID of around 1.8% (0.5–5.1%). Excluding Japan, all Organisation for the Economic Co-operation and Development member countries permanently exclude individuals with a history of IDU from donating. ConclusionNumerous research gaps meant that the study’s expert Review Committee was unable to recommend altering Australia’s current IDU-related blood donation guidelines. However, having identified critical knowledge gaps and future areas of research, the review made important steps toward changing the criteria.

Improving the screening of blood donors with syphilis rapid diagnostic test (RDT) and rapid plasma reagin (RPR) in low- and middle-income countries (LMIC).

Syphilis testing conventionally relies on a combination of non-treponemal and treponemal tests. The primary objective of this study was to describe the positive predictive value (PPV) of a screening algorithm in a combination of a treponemal rapid diagnostic test (RDT) and rapid plasma reagin (RPR) test at Komfo Anokye Teaching Hospital (KATH), Ghana. From February 2014 to January 2015, 5 mL of venous blood samples were taken from 16 016 blood donors and tested with a treponemal RDT; 5 mL of venous blood was taken from 526 consenting initial syphilis sero-reactive blood donors. These RDT reactive samples were confirmed with an algorithm, applying the Vitros® /Abbott-Architect® algorithm as gold standard. A total of 478 of 526 RDT reactive donors were confirmed positive for syphilis, making a PPV of 90·9%. Of the 172 (32·7%) donors who were also RPR positive, 167 were confirmed, resulting in a PPV of 97·1%. The PPV of the combined RDT and RPR (suspected active syphilis) testing algorithm was highest among donors at an enhanced risk of syphilis, family/replacement donors (99·9%), and among voluntary donors above 25 years (98·6%). Screening of blood donors by combining syphilis RDT and RPR with relatively good PPV may provide a reasonable technology for LMIC that has a limited capacity for testing and can contribute to the improvement of blood safety with a minimal loss of donors.

Risk Perception and Its Role in Attitudes Toward Blood Transfusion: A Qualitative Systematic Review

Despite improvements in blood safety making transfusion a much safer clinical procedure, the general public still perceives it as risky. We systematically reviewed available literature to examine evidence regarding the reasons and causes behind this perception. Electronic databases including PubMed, Cochrane Library, and EMBASE for literature dating back to the 1980s were searched. Eligible studies collected information on blood recipients' demographics, measures of risk domains (sets of values that risks encompass), and general knowledge of blood transfusion in terms of risks and benefits. Each study was assessed for quality of data, research method, and relevant findings. A scoring system was used to subjectively rate the overall quality of each study. Each study was reviewed for its method of data collection and information abstracted on hazards and conceptual dimensions used to measure risk. Risk perception between blood transfusion and other hazards including alternatives to transfusion were compared. Fifteen studies met the inclusion criteria, all of which were conducted outside the United States, with most of the studies published more than 10 years ago and conducted by only 3 research groups. Five studies were rated as being very good, four good, five fair, and one of poor quality. The finding of the studies consistently show that objective or raw knowledge is not correlated with risk perception, but subjective or calibrated knowledge is. Thus, it is what people think they know rather than what they actually do know that influences risk perception of transfusion. Of the 3 common conceptual domains-dread, unknown risk, and benefits-blood transfusion was found to be of intermediate dread, intermediate unknown risk, and most beneficial compared with other hazards. Donated blood was found to have lower perceived risk than all other alternatives to transfusion, except for use of autologous blood. There is a lack of recent studies on allogeneic transfusion. However, the more recent studies show that perceived high risk is still prevalent in the general public. The available risk perception studies suggest that although blood transfusion is safe, elevated risk perception of infections persists. Studies of the US population are needed to better understand the influence of both psychological and scientific factors.

How can we explain the gap between randomised studies and ‘real life’ practice in postoperative transfusion triggers? Do we need to change recommended thresholds for transfusion?

At the present time, improvements in blood safety, particularly in terms of transfusion-transmitted viral infections, have tended to trivialise the risks of transfusion, suggesting that the risk of no transfusion or a delay in transfusion appears to be much higher than the risk of transfusion itself. Indeed, in a French survey performed on anaesthesia-related mortality, 1 the estimated number of anaesthetic procedures was 7756121 per year, with a total of 419 deaths totally or partly related to anaesthesia. Several common causes of death were identified, but consequences of haemorrhage and anaemia played a disturbing role. It was estimated from this survey that nearly 100 deaths occur perioperatively in France every year as the result of inadequate blood management. Surprisingly, more deaths occurred which were related partly to delayed or absent blood transfusion, and only a small proportion of complications occurred after an episode of transfusion, emphasising the safety of blood transfusion in contemporary practice. Moreover, 58% of the reported deaths occurred more than 24h after surgery. In the presence of massive blood loss, anaemia can lead to myocardial infarction (MI) and cardiovascular deaths, which are still the most frequent causes of death after noncardiac surgery, as demonstrated in the huge Norwegian Register of more than 60000 elective orthopaedic operations. 2,3 Patients undergoing noncardiac

Situation actuelle et perspectives de la transfusion sanguine au Togo

We report the successive stages of the reorganization of the blood transfusion sector in Togo. The starting point was the elaboration of the national policy of blood transfusion, then the adoption of a decree organizing the sector as well the various decree of application, particularly that related to transfusion good practices. The current policy recommends two poles of qualification of the blood ant its components and the creation of six stations of collection and distribution attached to these poles. The reorganization started with the rehabilitation of the National Blood Transfusion Centre (CNTS) in Lomé. If the problem of human resources is alarming, especially the availability of hemobiologists, the rehabilitation allowed the increase of the blood collection passing from 5272 donations in December 2003 to 18 164 in December 2008. However, the requirement of blood products is satisfied in 50% in all the country. In 2003, 24% of the blood products were rejected for positive viral markers against 8.37% in 2008 in relation with the improvement of blood safety. Efforts must be continued to reinforce it in the CNTS and to make a better selection of the donors at the Regional Blood Transfusion Centre (CRTS) de Sokodé. The analysis of the weak points of the sector (human resource insufficiency, shortage of the blood products, blood safety) made it possible to indicate solutions to improve the sector of blood transfusion sector. Future outcome is funded in the blood transfusion safety development project in Togo financed by the Agence française de développement (AFD, French development agency).

The blood donor in sub-Saharan Africa: a review

The high prevalence of numerous endemic and epidemic diseases such as malaria, HIV infection and viral hepatitis in some areas of sub-Saharan Africa (SSA) affects the health status of blood donors. Considering the difficulties in ensuring sufficient and safe blood supply, analysing epidemiological factors that impact blood donors in this community may further bring light on issues of supply and safety, and help in planning for its rational use. This review does not aim to propose new strategies but describes the main characteristics of blood donors in SSA as collected from different reports. Data were mainly obtained from the reports of the World Health Organization and national blood transfusion programmes and also from relevant literature and conference reports. Several characteristics are common in blood donors, such as the predominance of young adult males, the high frequency of Transmission-transmitted Infections (TTIs) and some erythrocytic phenotypes. The data indicate variations in the level of improvement of blood collection and blood safety from one area to another, particularly in the field of donor motivation or screening strategies for TTIs. These data could be useful to supplement previous reports and to provide updates for governments and international organizations' programs involved in the improvement of blood safety in Africa.

The six questions of pathogen reduction technology: An overview of current opinions

The current measures to ensure blood safety include: donor selection, conventional serology testing for infectious markers by ELISA and NAT, leukoreduction, UV/Gamma irradiation and pathogen reduction technologies (PRT). These measures offer some conceptual assurance on continual improvement in blood safety, but with respect to PRT, there are at least six unresolved questions [6 Qs] that still need to be addressed to make them universally acceptable. The current status of PRT for plasma, platelets and red blood cells is explored through comparative analyses, in tabulated format, to help in answering the questions posed by the authors of this overview.

Blood safety in Sub‐Saharan Africa: a multi‐factorial problem

Although the World Health Organization (WHO) has set targets for safe blood by 2012, Sub-Saharan Africa remains confronted with multi-factorial issues that compromise blood safety in most countries of the region. Some of these include the development and implementation of national policies for transfusion, the recruitment of voluntary and unpaid donors, proper screening of collected blood as well as a strategy for its rational use in a setting already plagued by a high prevalence of blood-borne agents, poverty, and sometimes organizational deficits. Furthermore, the organization of hemovigilance, as well as quality systems that could monitor transfusion practices is lacking in these settings. There is no funding and global improvement of blood safety has to be cheap to be feasible. Specific solutions for the African continent need to be developed and implemented. This paper examines the current status and difficulties of blood safety in Africa and reviews available data on transfusion medicine in the region.

Population genetic history of hepatitis C virus 1b infection in China

Subtype 1b is the most common strain of Hepatitis C virus (HCV) in China. Here, the molecular epidemiology and epidemic history of this strain were investigated by conducting phylogenetic and population genetic analyses of E1 and NS5B gene sequences sampled from nine Chinese cities. The phylogenetic analysis indicated the presence of two clusters of Chinese strains that did not include reference strains from other countries, suggesting that these clusters represent two independent chains of HCV transmission within China. The remaining Chinese isolates were more closely related to reference strains from other countries. The date of origin and past population dynamics of the two groups were investigated using a new population genetic method, the Bayesian skyline plot. The estimated dates of origin of both groups coincide with the period of the Chinese 'Cultural Revolution' during the years 1966-1976. Both groups grew at a rapid exponential rate between approximately 1970 and approximately 1990, after which transmission slowed considerably. Possible explanations for the groups' fast spread and subsequent slowdown are discussed, including parenteral transmission by unsafe injection, iatrogenic transmission by infected blood or blood products and improvements in blood safety since 1990. These results shed light on HCV transmission in China and may help to predict the future burden of HCV-related disease in the country.

Screening Volunteer Blood Donations for Transmissible Infectious Diseases

labmedicine.com November 2005 Volume 36 Number 11 LABMEDICINE 717 Blood transfusion has provided life-saving support for the last 80 years. Transfusions are necessary in a variety of circumstances, which include medical care, surgical treatment, and acute trauma cases. It is estimated that annual need for transfusions exceeds 20 million blood products annually in the United States. There are little long-term effects on recipients, and the risk of infection is low for currently screened infectious agents.1,2 However, there remains an unknown risk of new emerging blood borne pathogens for which donor screening is currently not available. Since the early days of blood transfusion there has been a steady progression in the identification of transmissible infectious diseases, with consequent improvement in blood safety. Historically, blood donor screening used health histories, a self-deferral process and pre-selected donor groups to enhance safety. The number of transfusion-transmitted infectious diseases (TTIDs) has increased since the beginning of routine blood transfusion in the late 1930s.3 Syphilis was the first TTID for which prospective blood donors were tested in the 1950s.4 Although post-transfusion hepatitis was recognized in the 1940s, it was thought to be transient and a minor infection. Awareness of TTIDs became more significant, along with the public demand for increased blood safety, with the introduction of human immunodeficiency virus (HIV) into the blood donor pool. The first acquired immunodeficiency syndrome (AIDs) case was reported in 1981, with the first reported AIDS transfusion related case in 1982.5,6 It was not until 1985 that blood banks had a test available to screen blood for the AIDS virus. For the 4-year interim period, volunteer blood donors were screened based on high-risk behavior and self-exclusion. Hepatitis was the second most feared transfusion associated chronic infection, caused by hepatitis B and hepatitis C (previously known as non A/non B). The transfusion risk for contracting hepatitis was 25% before 1965.2 Immunoassays were first developed for the hepatitis B virus in the 1970s.7 Since that time, there have been unprecedented efforts by the transfusion medicine industry to make the blood supply safer. As a result, chronic post-transfusion infections have diminished significantly (Table 1). Reasons for improved blood safety include2: • Discontinued paying donors (moved to an all volunteer donor pool). • Development of an antibody test for hepatitis B surface antigen (HBsAg) in 1976-1977. • Instituted better donor screening methods including health history and demographics. • Added surrogate testing for non-A-non-B hepatitis, including alanine aminotransferase in the late 1980s. Screening Volunteer Blood Donations for Transmissible Infectious Diseases

Trends in risk of transfusion-transmitted viral infections (HIV, HCV, HBV) in France between 1992 and 2003 and impact of nucleic acid testing (NAT)

Monitoring trends in residual risk of transfusion-transmitted viral infections is important to assess improvements in blood safety and to adapt the risk reduction policies. These trends were analysed in France over 4 periods of 3 years (1992-1994, 1995-1997, 1998-2000 and 2001-2003). The 2001-2003 estimates were compared to the results of HIV-1 and HCV NAT implemented on all blood donations in July 2001. Due to improvements in donor recruitment and selection, continuing progress in screening assays, and preventive measures taken in the community to control infections, a significant decrease was observed in residual risks for HIV, HCV and HBV between 1992 and 2003. The residual risk is currently extremely low: for the 2001-2003 period, this risk was estimated at 1 in 3.15 million donations for HIV, at 1 in 10 million for HCV and at 1 in 640,000 for HBV. Of the 6.14 million donations screened with NAT between July 2001 and December 2003 in France, 2 HIV-positive and 3 HCV-positive donations were discarded thanks to NAT, representing a yield of 1 in 3.07 million for HIV and 1 in 2.05 million for HCV. These results show the limited benefit of NAT and suggest that its cost-effectiveness is poor.

Risque résiduel de transmission du VIH, du VHC et du VHB par transfusion sanguine entre 1992 et 2002 en France et impact du dépistage génomique viral

Background. – Monitoring trends in residual risk of transfusion-transmitted viral infections is important to assess improvements in blood safety. These trends were analysed over nine overlapping periods of 3 years from 1992 to 2002. The 2000–2002 estimates were compared to the results of HIV-1 and HCV NAT implemented on all blood donations in July 2001. Method. – As risk is mainly associated with the window period, residual risks were estimated by multiplying incidence rates by the durations of the window periods. For the first seven periods, incidence rates were calculated from data collected by the blood centres belonging to the Transfusion–Transmissible Agents Working Group which collect more than 50% of blood donations in France, and for the two last periods, on the overall blood supply. Results. – On the 2000–2002 period, residual risks without NAT were estimated at 1 in 1 400 000 for HIV, at 1 in 1 000 000 for HCV and at 1 in 400 000 for HBV. With minipool NAT, the residual risk become nearly two times lower for HIV (1 in 2.5 million donations) and seven times lower for HCV (1 in 6.65 million donations). For HIV, of the 4.9 million donations screened with NAT between July 2001 and June 2003, two were remote thanks to the NAT, which is consistent with the NAT expected yield. Concerning HCV, one out of the four WP predicted cases was detected with NAT. Without NAT, the overall residual risk for the three viruses combined (HIV, HCV, HBV) decreased from 1 in 65 000 to 1 in 235 000 donations between 1992 and 2002. Since the implementation of NAT, the current overall residual risk is 1 in 325 000 donations (28% less than without NAT). Conclusion. – NAT results confirm the validity of residual risk estimates given by the model, and the limited benefit of genomic screening due to the very low level of residual risk at the time of its implementation.

Trends in residual risk of transfusion-transmitted viral infections in France between 1992 and 2000.

Monitoring trends in residual risks of transfusion-transmitted viral infections (HIV, HTLV, HBV, and HCV) is important to assess improvements in blood safety. In France, theses trends were analyzed between 1992 and 2000. As risk is predominantly associated with the window period, residual risks were estimated by multiplying incidence rates by the durations of the window periods. Incidence rates were calculated from the data collected by the blood transfusion centers belonging to the Transfusion-Transmissible Agents Working Group, which currently collects more than 50 percent of the 2.5 million blood samples donated each year in France. Trend analysis showed a significant decrease in residual risks for HCV (p = 0.01) and HBV (p < 0.001). Although residual risks decreased for HIV and HTLV, the trends were not significant. In 1998 through 2000, residual risks were estimated to be 1 in 470,000 donations for HBV, 1 in 860,000 for HCV, 1 in 1,370,000 for HIV, nil for HTLV, and 1 in 250,000 for the four viruses combined. In France, the current risk of a blood recipient becoming infected with a retrovirus or a hepatitis virus is extremely low. The implementation of NAT in July 2001 is predicted to reduce the residual risk to 1 in 2,700,000 donations for HIV and 1 in 8,300,000 for HCV.

Is There Still a Place for Autologous Blood Predonation?

SUMMARYInterest in autologous blood procurement was stimulated in the 1980s by a renewed awareness that infectious diseases, including post‐transfusion hepatitis and human immunodeficiency virus (HIV), are transmissible by blood transfusion. Preoperative autologous blood donation (PAD), acute normovolemic hemodilution (ANH), and intraoperative/postoperative autologous blood cell recovery and reinfusion were each techniques identified and promoted in the surgical arena in response to medical and legal pressures to minimize allogeneic blood exposure.The role of autologous blood procurement in surgery continues to evolve based on improved blood safety, increased blood costs, and emerging pharmacologic alternatives to blood transfusion. PAD became accepted as a standard practice in certain elective surgical settings, such as total joint replacement surgery, so that by 1992, over 6% of the blood transfused in the U.S. was autologous. In contrast, ANH was rarely practiced and published data regarding its merits were scant. Subsequently, substantial improvements in blood safety were accompanied by a decline in PAD (Table 1) as well as by an interest in ANH as an alternative, lower‐cost autologous blood procurement strategy. Nevertheless, public perception of blood safety and the reluctance to accept allogeneic blood transfusion in the elective transfusion setting, along with emerging blood inventory shortages, continue to make the application of autologous blood procurement strategies a subject of ongoing debate. The current roles of these strategies are presented.