-
1.
Higher Risk of HEV Transmission and Exposure among Blood Donors in Europe and Asia in Comparison to North America: A Meta-Analysis
Wolski A, Pischke S, Ozga AK, Addo MM, Horvatits T
Pathogens (Basel, Switzerland). 2023;12(3)
Abstract
BACKGROUND AND AIMS The increasing number of diagnosed hepatitis E virus (HEV) infections in Europe has led to the implementation of the testing of blood products in various countries. Many nations have not yet implemented such screening. To assess the need for HEV screening in blood products worldwide, we conducted a systematic review and meta-analysis assessing HEV RNA positivity and anti-HEV seroprevalence in blood donors. METHODS Studies reporting anti-HEV IgG/IgM or HEV RNA positivity rates among blood donors worldwide were identified via predefined search terms in PubMed and Scopus. Estimates were calculated by pooling study data with multivariable linear mixed-effects metaregression analysis. RESULTS A total of 157 (14%) of 1144 studies were included in the final analysis. The estimated HEV PCR positivity rate ranged from 0.01 to 0.14% worldwide, with strikingly higher rates in Asia (0.14%) and Europe (0.10%) in comparison to North America (0.01%). In line with this, anti-HEV IgG seroprevalence in North America (13%) was lower than that in Europe (19%). CONCLUSIONS Our data demonstrate large regional differences regarding the risk of HEV exposure and blood-borne HEV transmission. Considering the cost-benefit ratio, this supports blood product screening in high endemic areas, such as Europe and Asia, in contrast to low endemic regions, such as the U.S.
-
2.
The Medical Relevance of Toxoplasma Infections in Terms of the Safety of Blood Recipients under Immunosuppression-A Meta-Analysis
Wesołowski, R., Pawłowska, M., Mila-Kierzenkowska, C.
Microorganisms. 2023;11(8)
Abstract
Laboratory diagnosis of Toxoplasma gondii infection plays a crucial role in ensuring the safety of blood recipients, especially in the case of immunosuppressed people, such as organ transplant patients. Toxoplasmosis, caused by the parasite Toxoplasma gondii, is a potential threat to people with weakened immune systems, and blood transfusions from infected donors can lead to severe complications. In this publication, we analyze the medical relevance of Toxoplasma infection in the context of the safety of blood recipients, focusing on the immunosuppressed patient population. We present various diagnostic methods, such as serological, molecular, and microscopic tests, which can detect the presence of Toxoplasma gondii in donors' blood. We also discuss the importance of adequately interpreting diagnostic results, considering risk factors, and detectability of the infection. We pay special attention to high-sensitivity and -specificity diagnostic techniques, which allow us to minimize the risk of Toxoplasma gondii transmission to blood recipients. Our findings have important implications for clinical practice and organ transplantation guidelines, emphasizing the need to diagnose and monitor Toxoplasma infections in blood donors and recipients.
-
3.
Meta-analysis of bacterial growth characteristics in platelet components: Refining the inputs of a simulation analysis comparing the relative safety of testing strategies
Walker, B. S., Schmidt, R. L., White, S. K., Metcalf, R. A.
Transfusion. 2023
-
-
-
-
Editor's Choice
Abstract
BACKGROUND The relative safety of bacterial risk control strategies for platelets that include culture with or without rapid testing has been compared using simulation analysis. A wide range of bacterial lag and doubling times were included. However, published data on growth rates are available and these data have not been synthesized. We conducted a systematic review and meta-analysis to estimate growth rates and used these estimates to refine a comparative safety analysis of bacterial risk control strategies in the FDA guidance STUDY DESIGN AND METHODS Data were extracted from published studies on bacterial growth rates in platelet components during storage. These data were used to estimate the practical range of growth rates. This refined the inputs for a simulation model comparing the safety of the testing strategies. RESULTS In total, 108 growth curves for 11 different aerobic organisms were obtained. Doubling times ranged from 0.8 to 12 h, but the lower 90% range was approximately 1-5 h. The revised comparative safety simulation using the narrower 1-5-h range showed similar rankings to the prior simulation, with 48-h large-volume delayed sampling with 7-day expiration (48C-7) demonstrating the lowest-ranking relative performance at the 10(3) and 10(5) colony forming unit (CFU)/mL exposure thresholds. DISCUSSION This was a two-step study. First, meta-analysis of published data on aerobic bacterial growth rates in stored platelets showed the vast majority of doubling times were 1-5 h. Next, an updated comparative safety simulation yielded similar results to a prior study, with 48C-7 showing the least favorable relative safety performance.
PICO Summary
Population
Recipients of platelet transfusions (12 studies).
Intervention
Systematic review and meta-analysis to estimate growth rates and used these estimates to refine a comparative safety analysis of bacterial risk control strategies in the FDA guidance.
Comparison
Outcome
Data were extracted from published studies on bacterial growth rates in platelet components during storage. These data were used to estimate the practical range of growth rates. This refined the inputs for a simulation model comparing the safety of the testing strategies. In total, 108 growth curves for 11 different aerobic organisms were obtained. Doubling times ranged from 0.8 to 12 h, but the lower 90% range was approximately 1-5 h. The revised comparative safety simulation using the narrower 1-5-h range showed similar rankings to the prior simulation, with 48-h large-volume delayed sampling with 7-day expiration (48C-7) demonstrating the lowest-ranking relative performance at the 10(3) and 10(5) colony forming unit (CFU)/mL exposure thresholds.
-
4.
What influences decisions to donate plasma? A rapid review of the literature
Berger, M., Easterbrook, A., Holloway, K., Devine, D., Bansback, N.
Vox sanguinis. 2023
-
-
-
-
Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES Plasma has become an essential ingredient for various medical treatments. Many blood collection agencies rely on voluntary non-remunerated donation when collecting plasma, but at present many do not collect sufficient plasma to meet domestic demands. This rapid review sought to explore the factors that have been found to influence people's decisions to donate plasma to inform future research. METHODS Searches were conducted in PubMed, PsycINFO, Social Sciences Citation Index and CINAHL for peer-reviewed journal articles that discussed plasma donation and the factors associated with donor behaviour. Pertinent information from included articles was extracted and arranged in themes. RESULTS In total, 33 articles were included in this review. Three main themes were identified by the authors. The first focused on site-level factors related to blood collection agencies' engagement with plasma donors and their influence on plasma donation experiences. The second theme considered how individual characteristics and experiences influence willingness to donate plasma. The third theme examined social and cultural-level factors, such as how social networks and community shape perceptions and experiences with donation. CONCLUSION Our findings suggest that the current understanding of plasma donation is focused mainly on converting whole blood donors and also centres on individual-level factors to donation. Further research must examine what factors attract non-whole blood donors to become plasma donors, focusing on broader social-level influences. This review will inform policies and interventions for blood collection agencies to increase plasma donors.
PICO Summary
Population
Plasma donors (33 studies).
Intervention
Rapid review exploring the factors influencing people's decisions to donate plasma.
Comparison
Outcome
Three main themes were identified by the authors. The first focused on site-level factors related to blood collection agencies' engagement with plasma donors and their influence on plasma donation experiences. The second theme considered how individual characteristics and experiences influence willingness to donate plasma. The third theme examined social and cultural-level factors, such as how social networks and community shape perceptions and experiences with donation.
-
5.
Pathogen inactivation methods to prevent transfusion-transmissible arboviruses
Giménez-Richarte Á, Ortiz de Salazar MI, Giménez-Richarte MP, Larrea L, Arbona C, Marco P, Ramos-Rincón JM
Tropical medicine & international health : TM & IH. 2023
-
-
-
-
Editor's Choice
Abstract
OBJECTIVE Arboviruses are emerging as a relevant threat to transfusion safety. Pathogen inactivation methods may reduce the risk of transmission through transfusion, as long as they meet minimum standards for effectiveness. This study aims to assess the log reduction of viral load achieved with different pathogen inactivation methods, according to the blood product they are used on and the arbovirus targeted. METHODS Systematic literature review and meta-analysis. Searches were conducted in MEDLINE and Embase. The study protocol was registered in PROSPERO CRD42022312061. We selected records reporting the log reduction of viral load achieved with the main pathogen inactivation methods (amotosalen + UVA light [INTERCEPT], riboflavin + UV light [Mirasol], methylene blue + visible light/UVC light [THERAFLEX], solvent detergent, amustaline [INTERCEPT] and PEN110 [Inactine]), applied to any blood product (plasma, platelets, red blood cells or whole blood) and for any arbovirus. The log reduction of viral loads was assessed by obtaining the mean log reduction factor (LRF). We compared and classified the LRF of different techniques using statistical methods. RESULTS We included 59 publications reporting LRF results in 17 arboviruses. For 13 arboviruses, including Chikungunya virus, Dengue virus, West Nile virus, and Zika virus, at least one of the methods achieves adequate or optimal log reduction of viral load - mean LRF ≥4. The LRF achieved with riboflavin + UV light is inferior to the rest of the techniques, both overall and specifically for plasma, platelets preserved in platelet additive solution (PAS)/plasma, and red blood cells/whole blood. The LRF achieved using Mirasol is also lower for inactivating chikungunya virus, dengue virus, and Zika virus. For West Nile virus, we found no significant differences. In plasma, the method that achieves the highest LRF is solvent/detergent; in platelets, THERAFLEX and INTERCEPT; and in red blood cells/whole blood, PEN110 (Inactine). CONCLUSION Not all pathogen inactivation methods achieve the same LRF, nor is this equivalent between the different arboviruses or blood products. Overall, the LRFs achieved using riboflavin + UV light (Mirasol) are inferior to those achieved with the rest of the pathogen inactivation methods. Regarding the others, LRFs vary by arbovirus and blood product. In light of the threat of different arboviruses, blood establishments should have already validated pathogen inactivation methods and be logistically prepared to implement these techniques quickly.
PICO Summary
Population
Whole blood or human blood products from blood donors (59 studies).
Intervention
Systematic literature review and meta-analysis assessing the log reduction of viral load achieved with different pathogen inactivation methods, according to the blood product they were used on and the arbovirus targeted.
Comparison
Outcome
The included studies reported log reduction factor (LRF) results in 17 arboviruses. For 13 arboviruses, including Chikungunya virus, Dengue virus, West Nile virus, and Zika virus, at least one of the methods achieved adequate or optimal log reduction of viral load - mean LRF ≥4. The LRF achieved with riboflavin + UV light was inferior to the rest of the techniques, both overall and specifically for plasma, platelets preserved in platelet additive solution (PAS)/plasma, and red blood cells/whole blood. The LRF achieved using Mirasol was also lower for inactivating Chikungunya virus, Dengue virus, and Zika virus. For West Nile virus, no significant differences were found. In plasma, the method that achieved the highest LRF was solvent/detergent; in platelets, THERAFLEX and INTERCEPT; and in red blood cells/whole blood, PEN110 (Inactine).
-
6.
Men who have sex with men and risk for transfusion-transmissible infections in blood donors in Western countries: A systematic review update
Schroyens, N., Borra, V., Compernolle, V., Vandekerckhove, P., De Buck, E.
Vox sanguinis. 2023
-
-
-
-
Editor's Choice
Abstract
BACKGROUND AND OBJECTIVES This systematic review update summarizes evidence concerning transfusion-transmissible infections (TTIs) in male blood donors reporting sex with another man (MSM) or after easing the MSM deferral period. MATERIALS AND METHODS We searched five databases, including studies comparing MSM versus non-MSM donors (Type I), MSM deferral periods (Type II) or infected versus non-infected donors (Type III) in Western countries, and used GRADE to determine evidence certainty. RESULTS Twenty-five observational studies were included. Four Type I studies suggest that there may be an increased risk for overall TTIs, human immunodeficiency virus (HIV), hepatitis B virus (HBV) and syphilis in MSM donors, but the evidence is very uncertain. There was insufficient evidence of MSM with low-risk sexual behaviour. A Type II study indicates that easing the MSM deferral period to 1 year may have little to no effect on TTI risk. TTI prevalence in blood donors under 5-year, 1-year, 3-month or risk-based deferral in eight other Type II studies was too low to provide clear conclusions on the effect of easing the deferral. Three Type III studies reported that MSM may be a risk factor for HIV. Increased risk of HBV, hepatitis C virus and HTLV-I/II could not be shown. The evidence from Type III studies is very uncertain. CONCLUSION There may be an increased risk of HIV in MSM blood donors. Shortening the deferral from permanent to 1 year may have little to no effect on TTI risk. However, there is limited, unclear evidence from observational studies concerning the impact of introducing 3-month or risk-based deferrals.
PICO Summary
Population
Blood donors or people eligible to give blood, living in Australia, Canada, Europe, New Zealand and USA (25 observational studies).
Intervention
Systematic review summarizing published studies on the relation between men who have had sex with another man (MSM) or an MSM deferral policy and the risk of transfusion-transmissible infections (TTI) markers in donated blood.
Comparison
Outcome
The three types of included studies compared: MSM vs. non-MSM donors (Type I); MSM deferral periods (Type II); and infected vs. non-infected donors (Type III). Four Type I studies suggested that there may be an increased risk for overall TTIs, human immunodeficiency virus (HIV), hepatitis B virus (HBV) and syphilis in MSM donors, but the evidence was very uncertain. There was insufficient evidence of MSM with low-risk sexual behaviour. A Type II study indicated that easing the MSM deferral period to 1 year may have little to no effect on TTI risk. TTI prevalence in blood donors under 5-year, 1-year, 3-month or risk-based deferral in eight other Type II studies was too low to provide clear conclusions on the effect of easing the deferral. Three Type III studies reported that MSM may be a risk factor for HIV. Increased risk of HBV, hepatitis C virus and HTLV-I/II could not be shown. The evidence from Type III studies was very uncertain.
-
7.
Global epidemiology of occult hepatitis B virus infections in blood donors, a systematic review and meta-analysis
Takuissu, G. R., Kenmoe, S., Amougou Atsama, M., Atenguena Okobalemba, E., Mbaga, D. S., Ebogo-Belobo, J. T., Bowo-Ngandji, A., Oyono, M. G., Magoudjou-Pekam, J. N., Kame-Ngasse, G. I., et al
PloS one. 2022;17(8):e0272920
Abstract
This study aimed to assess the global prevalence of occult hepatitis B in blood donors. We searched PubMed, Web of Science, Global Index Medicus, and Excerpta Medica Database. Study selection and data extraction were performed by at least two independent investigators. Heterogeneity (I2) was assessed using the χ2 test on the Cochran Q statistic and H parameters. Sources of heterogeneity were explored by subgroup analyses. This study is registered with PROSPERO, number CRD42021252787. We included 82 studies in this meta-analysis. The overall prevalence of OBI was 6.2% (95% CI: 5.4-7.1) in HBsAg negative and anti-HBc positive blood donors. Only sporadic cases of OBI were reported in HBsAg negative and anti-HBc negative blood donors. The overall prevalence of OBI was 0.2% (95% CI: 0.1-0.4) in HBsAg negative blood donors. The prevalence of OBI was generally higher in countries with low-income economic status. The results of this study show that despite routine screening of blood donors for hepatitis B, the transmission of HBV by blood remains possible via OBI and/or a seronegative window period; hence there is a need for active surveillance and foremost easier access to molecular tests for the screening of blood donors before transfusion.
-
8.
Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs
Pati I, Masiello F, Pupella S, Cruciani M, De Angelis V
Pathogens (Basel, Switzerland). 2022;11(6)
Abstract
In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel-Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.
-
9.
Impact of disasters on blood donation rates and blood safety: A systematic review and meta-analysis
Laermans J, O D, Van den Bosch E, De Buck E, Compernolle V, Shinar E, Vandekerckhove P
Vox sanguinis. 2022
-
-
Free full text
-
Abstract
BACKGROUND AND OBJECTIVES Timely and adequate access to safe blood forms an integral part of universal health coverage, but it may be compromised by natural or man-made disasters. This systematic review provides MATERIALS AND METHODS Five databases (The Cochrane Library, MEDLINE, Embase, Web of Science and CINAHL) were searched until 27 March 2020 for (un)controlled studies investigating the impact of disasters on blood donation rates and/or safety. Risk of bias and overall certainty of the evidence were assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS Eighteen observational studies were identified, providing very low certainty of evidence (due to high risk of bias, inconsistency and/or imprecision) on the impact of natural (12 studies) and man-made/technological (6 studies) disasters. The available evidence did not enable us to form any generalizable conclusions on the impact on blood donation rates. Meta-analyses could not detect any statistically significant changes in transfusion-transmissible infection (TTI) rates [hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2, human T-lymphotropic virus I and II (HTLV-I/II) and syphilis] in donated blood after a disaster, either in first-time or repeat donors, although the evidence is very uncertain. CONCLUSION The very low certainty of evidence synthetized in this systematic review indicates that it is very uncertain whether there is an association between disaster occurrence and changes in TTI rates in donated blood. The currently available evidence did not allow us to draw generalizable conclusions on the impact of disasters on blood donation rates.
-
10.
Bacterial culture time to detection in platelet components: An evidence synthesis and estimation of detection failures
Walker BS, Schmidt RL, Moore RA, White SK, Fisher MA, Metcalf RA
Transfusion. 2022
-
-
-
-
Editor's Choice
Abstract
BACKGROUND Non-pathogen reduction platelet bacterial risk control strategies in the US FDA guidance include at least one culture. Almost all of these strategies have a culture hold time of ≥12 h. Studies have reported time to detection (TTD) of bacterial cultures inoculated with bacteria from contaminated platelets, but these data and estimates of risk associated with detection failures have not been synthesized. METHODS We performed a literature search to identify studies reporting TTD for samples obtained from spiked platelet components. Using extracted data, regression analysis was used to estimate TTD for culture bottles at different inoculum sizes. Detection failures were defined as events in which contaminated components are transfused to a patient. We then used published data on time of transfusion (ToT) to estimate the risk of detection failures in practice. RESULTS The search identified 1427 studies, of which 16 were included for analysis. TTD data were available for 16 different organisms, including 14 in aerobic cultures and 11 in anaerobic cultures. For inocula of 1 colony forming unit (CFU), the average TTD for aerobic organisms was 19.2 h while it was 24.9 h in anaerobic organisms, but there was substantial overall variation. A hold time of 12 versus 24 h had minimal effect for most organisms. CONCLUSION TTD variation occurs between bacterial species and within a particular species. Under typical inventory management, the relative contribution of culture detection failures is much smaller than the residual risk from sampling failures. Increasing the hold period beyond 12 h has limited value.
PICO Summary
Population
Spiked platelets inoculated into bacterial cultures (16 studies).
Intervention
Systematic review to obtain summary estimates of the time to detection (TTD) for the most common contaminating organisms, and to estimate the risk of detection failures.
Comparison
Outcome
Regression analysis was used to estimate TTD for culture bottles at different inoculum sizes. Detection failures were defined as events in which contaminated components were transfused to a patient. Published data was used on time of transfusion to estimate the risk of detection failures in practice. TTD data were available for 16 different organisms, including 14 in aerobic cultures and 11 in anaerobic cultures. For inocula of 1 colony forming unit, the average TTD for aerobic organisms was 19.2 hours while it was 24.9 hours in anaerobic organisms, but there was substantial overall variation. A hold time of 12 vs. 24 hours had minimal effect for most organisms.
