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Nucleocapsid antibody assays can be used to estimate SARS-CoV-2 infection prevalence in regions implementing spike-based COVID-19 vaccines. However, poor sensitivity of nucleocapsid antibody assays in detecting infection after vaccination has been reported. We derived a lower cutoff for identifying previous infections in a large blood donor cohort (N = 142,599) by using the Ortho VITROS Anti-SARS-CoV-2 Total-N Antibody assay, improving sensitivity while maintaining specificity >98%. We validated sensitivity in samples donated after self-reported swab-confirmed infections diagnoses. Sensitivity for first infections in unvaccinated donors was 98.1% (95% CI 98.0-98.2) and for infection after vaccination was 95.6% (95% CI 95.6-95.7) based on the standard cutoff. Regression analysis showed sensitivity was reduced in the Delta compared with Omicron period, in older donors, in asymptomatic infections,

A core component of every blood program is the supply of safe blood and blood products. The elevated risk of transmission through these products is due to parvovirus B19 (B19V) resistance to the virus inactivation procedures. Our study aimed to screen asymptomatic blood donors for B19V at a tertiary care hospital in Chennai, Tamil Nadu, between September 2020 and June 2021. Sera from 106 healthy blood donors who tested negative for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV), syphilis, and malaria were tested for anti-B19V IgM and IgG using a qualitative indirect enzyme-linked immunosorbent assay (ELISA). In the study population, 23.5% (n = 25) of donors tested IgM positive, 38.6% (n = 41) tested IgG positive, and 7.5% (n = 8) tested positive for both IgM and IgG. A proportion of 61.3% (n = 65) of the blood donors tested IgG negative, suggesting they had no past B19V infection. B19V DNA was not detected in any of the subjects. The high seroprevalence of IgM indicates that blood donors may have been recently exposed to B19V, potentially posing a risk to immunocompromised individuals and those with hematological stress. Further longitudinal studies with a larger sample size are recommended to better understand the risk of B19V transfusion transmission. [ABSTRACT FROM AUTHOR]

Background Study Design and Methods Results Conclusions Combining pathogen reduction technology (PRT) with blood screening may alleviate concerns over the risk of transfusion‐transmitted infections (TTI) and support changes in blood donor selection to potentially increase blood availability. This study aimed to estimate the residual risk of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) transfusion‐transmission in Canada after implementing PRT, while eliminating deferrals for sexual risk behaviors.A probabilistic approach that combined Bayesian networks with Monte Carlo simulations was used to estimate the risk of transfusing HIV‐, HBV‐, or HCV‐contaminated blood components. Different scenarios were considered to compare the current residual risk after PRT implementation, with and without donor deferral criteria for sexual risk behaviors. Donor profiles and blood component outcomes were simulated based on a literature review including the prevalence and incidence of HIV, HBV, and HCV in the Canadian blood donor population; the use of current blood screening assays; and HIV, HBV, and HCV blood donor viral loads.In the universal PRT scenario (i.e., with PRT/without deferral criteria), the estimated risks of HIV, HBV, and HCV transmission were significantly lower than those in the currently observed scenario (i.e., without PRT/with deferral criteria).This risk model suggests that PRT for platelets and plasma (and eventually for RBCs when available) significantly reduces the residual risks of HIV, HBV and HCV transfusion‐transmission and could enable the removal of blood donor deferral criteria for sexual risk behaviors. [ABSTRACT FROM AUTHOR]

Background and Objectives: Blood safety measures used by blood establishments to increase blood component safety can be validated using Transfusion‐Relevant Bacterial Reference Strains (TRBRS). Ultra‐cold storage conditions and manual preparation of the current TRBRS may restrict their practical use. To address this issue, the ISBT Transfusion‐Transmitted Infectious Diseases Working Party's Bacterial Subgroup organized an international study to validate TRBRS in a user‐friendly, lyophilised format. Materials and Methods: Two bacterial strains Klebsiella pneumoniae PEI‐B‐P‐08 and Staphylococcus aureus PEI‐B‐P‐63 were manufactured as lyophilised material. The lyophilised bacteria were distributed to 11 different labs worldwide to assess the robustness for enumeration, identification and determination of growth kinetics in platelet concentrates (PCs). Results: Production of lyophilised TRBRS had no impact on the growth properties compared with the traditional format. The new format allows a direct low‐quantity spiking of approximately 30 bacteria in PCs for transfusion‐relevant experiments. In addition, the lyophilised bacteria exhibit long‐term stability across a broad temperature range and can even be directly rehydrated in PCs without losing viability. Interlaboratory comparative study demonstrated the robustness of the new format as 100% of spiked PC exhibited growth. Conclusion: Lyophilised TRBRS provide a user‐friendly material for transfusion‐related studies. TRBRS in the new format have improved features that may lead to a more frequent use in the quality control of transfusion‐related safety measures in the future. [ABSTRACT FROM AUTHOR]

Background and Objectives: A plasma transfusion dose should be weight‐based (10–20 mL/kg), which equates to three to four units in an average‐sized adult; therefore, the transfusion of single units under most circumstances is sub‐therapeutic. Materials and Methods: This retrospective observational study examined the prevalence of single‐unit plasma transfusion in adults within a 12‐hospital system from 1 January 2018, to 31 December 2019. Results: During the study period, 5791 patients received plasma transfusions. The overall prevalence of single‐unit plasma was 17.1% for 988 patients. The majority, 3047 (52.6%), occurred at one hospital, 2132 (36.9%) among five hospitals and 612 (10.7%) at the remaining six hospitals. Cardiac and gastrointestinal (GI)/transplant transfused 2707 (46.8%), combined respiratory, neurological, orthopaedic and congenital/dermatology/other comprised 2133 (36.9%) of the six hospitals that transfused less than 200 patients, four (66.7%) transfused single units above the overall prevalence. Conclusion: In this hospital system, more than one in six patients received a transfusion of a single plasma unit. Six of the 12 hospitals had 89.5% of the patients who were transfused plasma. Six service lines transfused 83.7% of all patients receiving plasma. Hospitals that infrequently transfused plasma were more likely to under‐dose. [ABSTRACT FROM AUTHOR]

Background and Objectives: The detection of treponemal antibodies, which are used to make a diagnosis of syphilis, is important both for diagnostic purposes and as a mandatory blood donor test in most countries. We evaluated the feasibility of using Kode Technology to make syphilis peptide red cell kodecytes for use in column agglutination serologic platforms. Materials and Methods: Candidate Kode Technology function‐spacer‐lipid (FSL) constructs were made for the Treponema pallidum lipoprotein (TmpA) of T. pallidum, using the peptide and FSL selection algorithms, and then used to make kodecytes. Developmental kodecytes were evaluated against a large range of syphilis antibody reactive and non‐reactive samples in column agglutination platforms and compared against established methodologies. Overall, 150 reactive and 2072 non‐reactive Syphicheck assay (a modified T. pallidum particle agglutination) blood donor samples were used to evaluate the agreement rate of the developed kodecyte assay. Results: From three FSL‐peptide candidate constructs, one was found to be the most suitable for diagnostics. Of 150 Syphicheck assay reactive samples, 146 were TmpA–kodecyte reactive (97.3% agreement), compared with 58.0% with the rapid plasmin reagin (RPR) assay for the same samples. Against the 2072 expected syphilis non‐reactive samples the agreement rate for TmpA–kodecytes was 98.8%. Conclusion: TmpA–kodecytes are viable for use as cost‐effective serologic reagent red cells for the detection of treponemal antibodies to diagnose syphilis with a high level of specificity in blood centres. This kodecyte methodology also potentially allows for introduction of the reverse‐algorithm testing into low‐volume laboratories, by utilizing existing transfusion laboratory infrastructure. [ABSTRACT FROM AUTHOR]

Background: The large dengue (DENV) and chikungunya (CHIKV) outbreaks observed during the last decade across the world, as well as local transmissions in non‐endemic areas are a growing concern for blood safety. The aim of this study was to evaluate and compare the sensitivity of nucleic acid tests (NAT) detecting DENV and CHIKV RNA. Materials and Methods: Using DENV 1 to 4 International Standards, the limits of detection (LODs) calculated by probit analysis of two NAT assays; the cobas CHIKV/DENV assay (Roche Diagnostics) and the Procleix Dengue Virus Assay (Grifols) were compared. In addition, CHIKV‐RNA LOD of the cobas CHIKV/DENV assay was evaluated. Results: For dengue, the 95% LOD of the cobas assay ranged between 4.10 [CI95%: 2.70–8.19] IU/mL (DENV‐2) and 7.07 [CI95%: 4.34–14.89] IU/mL (DENV‐4), and between 2.19 [CI95%: 1.53–3.83] IU/mL (DENV‐3) and 5.84 [CI95%: 3.84–10.77] IU/mL (DENV‐1) for Procleix assay. The Procleix assay had a significant lower LOD for DENV‐3 (2.19 vs. 5.89 IU/mL) when compared to the cobas assay (p = 0.005). The 95% LOD for CHIKV‐RNA detection of the cobas assay was 4.76 [CI95%: 3.08–8.94] IU/mL. Discussion: The two NAT assays developed for blood donor screening evaluated in this study demonstrated high and similar analytical performance. Subject to an appropriate risk‐benefit assessment, they can be used to support blood safety during outbreaks in endemic areas or in non‐endemic areas as an alternative to deferring blood donors during local transmission likely to affect the blood supply. The development of multiplex assays is expected to optimize laboratory organization. [ABSTRACT FROM AUTHOR]

Background and Objectives Materials and Methods Results Conclusion Plasmodium species are naturally transmitted by Anopheles mosquitos. The parasite infects red blood cells (RBCs) and can be transfused with blood products. In non‐endemic areas, the main risk of infection arises from travellers coming back and people immigrating from malaria‐endemic regions. Endemic countries face a permanent risk of infection from transfusion‐transmitted malaria (TTM). TTM may cause life‐threatening complications in patients dependent on blood donations. This study aimed to investigate the efficacy of Plasmodium falciparum inactivation in RBC units by treatment with short‐wavelength ultraviolet C (UVC) light in the absence of photochemical additives.RBC units were spiked with P. falciparum to a parasite density of 0.1%–1% and irradiated with up to 4.5 J/cm2 UVC. The parasite density of UVC‐treated dilution series and untreated controls were compared over 3 weeks after irradiation.The lowest dose of 1.5 J/cm2 UVC led to a 3.1 log reduction in parasite load compared with the untreated control. The inactivation capacity was dose‐dependent. Strikingly, 4.5 J/cm2 led to ≥5.3 log unit reduction, which was equivalent to a complete inactivation in two out of three experiments.Pathogen reduction with UVC light was previously shown to be effective for different bacteria and viruses, but the inactivation of parasites in RBC concentrates was not addressed until now. The present study provides evidence for significant inactivation of P. falciparum‐infected RBCs by UVC light. [ABSTRACT FROM AUTHOR]

Background and Objectives Materials and Methods Results Conclusion The risk of transfusion‐transmitted malaria (TTM) infections is extremely low in Australia, and the cost‐effectiveness of the current screening strategy has not been assessed. This study aims to conduct a cost‐effectiveness analysis of different malaria screening strategies in blood donors as part of the risk‐based decision‐making framework.A decision tree model was developed to assess the cost‐effectiveness of five alternative malaria screening strategies from a healthcare sector perspective. Screening strategies combining total or partial removal of malaria testing with different deferral periods were considered. The probabilities of developing severe and uncomplicated TTM were based on a literature review of cases in non‐endemic areas since 2000. The health outcomes were quantified using disability‐adjusted life years. The costs of non‐returning donors due to deferral were also included. Deterministic and probabilistic sensitivity analyses were conducted to account for data uncertainty.The residual risks for all strategies were so low that the costs, mortality and morbidity associated with TTM are almost negligible. The overall costs were predominantly influenced by the costs of non‐returning blood donors. As a result, removal of malaria testing and applying a 28‐day deferral for at‐risk donors were the least costly and most cost‐effective of all the options considered.The current screening strategy for malaria in blood donors in Australia is not an efficient use of healthcare resources. Partial or total removal of malaria testing would bring significant cost savings without significantly compromising blood safety. [ABSTRACT FROM AUTHOR]

Background and Objectives Materials and Methods Results Conclusion To reduce the risk of transfusion‐transmitted malaria (TTM) from transfusible components, Australia tests for malaria antibodies in both travellers returning from and former residents of malaria‐endemic areas. The testing is performed a minimum of 120 days after last potential exposure. TTM is an extremely rare event and managing the risk adds considerable complexity. The objectives of this study were to analyse various testing and deferral strategies, considering the risk, donation numbers and operational complexities.A residual risk model was developed to calculate the risk of TTM in five testing/deferral strategies. Australian blood donor data from 2020 and 2021 were used and incorporated the incidence of parasitaemia, Plasmodium species and the malaria enzyme immunoassay test's failure rate. Donor and donation loss or gain and an operational assessment were performed.The current model's estimated risk of TTM is 1 in 67.9 million transfused units. Testing residents with a 120‐day plasma restriction for visitors without testing was found to have the same estimated risk, with an expected increase of 342 donations per year, significant cost savings and a 62% reduction in the number of donors requiring assessment.A strategy that involves testing residents of malaria areas only and a 120‐day plasma travel restriction would not significantly increase the risk of TTM, is operationally simpler, costs less and results in a small increase in donations. [ABSTRACT FROM AUTHOR]

This randomized controlled trial compared two dosing regimens of the polyvalent immunoglobulin available for hepatitis A post‐exposure prophylaxis in Australia. Participants were randomized to receive either 270 IU (standard dose) or 3.375 IU/kg (dose by weight). Quantitative serial serum hepatitis A antibody concentrations were measured at baseline and then on days 1, 3, 7, 28, and 50. Fifteen participants completed the trial. Serum hepatitis A antibody concentrations were not different between the study groups at any time point. Pharmacokinetic parameters estimated from participant data were not different between the study groups. The hepatitis A antibody level of all participants exceeded 10 mIU/mL at day 50. While no difference between dosing regimens was found in this study, further research should examine dosing at the lower limit of current Australian recommendations before making policy decisions. [ABSTRACT FROM AUTHOR]

During May 2018‒December 2022, we reviewed transfusion-transmitted sepsis cases in the United States attributable to polymicrobial contaminated apheresis platelet components, including Acinetobacter calcoaceticus‒baumannii complex or Staphylococcus saprophyticus isolated from patients and components. Transfused platelet components underwent bacterial risk control strategies (primary culture, pathogen reduction or primary culture, and secondary rapid test) before transfusion. Environmental samples were collected from a platelet collection set manufacturing facility. Seven sepsis cases from 6 platelet donations from 6 different donors were identified in patients from 6 states; 3 patients died. Cultures identified Acinetobacter calcoaceticus‒baumannii complex in 6 patients and 6 transfused platelets, S. saprophyticus in 4 patients and 4 transfused platelets. Whole-genome sequencing showed environmental isolates from the manufacturer were closely related genetically to patient and platelet isolates, indicating the manufacturer was the most probable source of recurrent polymicrobial contamination. Clinicians should maintain awareness of possible transfusion-transmitted sepsis even when using bacterial risk control strategies.

Abstract A core component of every blood program is the supply of safe blood and blood products. The elevated risk of transmission through these products is due to parvovirus B19 (B19V) resistance to the virus inactivation procedures. Our study aimed to screen asymptomatic blood donors for B19V at a tertiary care hospital in Chennai, Tamil Nadu, between September 2020 and June 2021. Sera from 106 healthy blood donors who tested negative for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV), syphilis, and malaria were tested for anti-B19V IgM and IgG using a qualitative indirect enzyme-linked immunosorbent assay (ELISA). In the study population, 23.5% (n = 25) of donors tested IgM positive, 38.6% (n = 41) tested IgG positive, and 7.5% (n = 8) tested positive for both IgM and IgG. A proportion of 61.3% (n = 65) of the blood donors tested IgG negative, suggesting they had no past B19V infection. B19V DNA was not detected in any of the subjects. The high seroprevalence of IgM indicates that blood donors may have been recently exposed to B19V, potentially posing a risk to immunocompromised individuals and those with hematological stress. Further longitudinal studies with a larger sample size are recommended to better understand the risk of B19V transfusion transmission.

During 2018–2021, eight septic transfusion reactions occurred from transfusion of platelet units contaminated with Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecarboxylata, or a combination of those environmental organisms. Whether biofilm formation contributed to evasion of bacterial risk mitigations, including bacterial culture, point-of-care testing, or pathogen-reduction technology, is unclear. We designed a 12-well plate-based method to evaluate environmental determinants of single-species and multispecies biofilm formation in platelets. We evaluated bacteria isolated from septic transfusion reactions for biofilm formation by using crystal violet staining and enumeration of adherent bacteria. Most combinations of bacteria had enhanced biofilm production compared with single bacteria. Combinations involving L. adecarboxylata had increased crystal violet biofilm production and adherent bacteria. This study demonstrates that transfusion-relevant bacteria can produce biofilms well together. More work is needed to clarify the effect of biofilms on platelet bacterial risk control strategies, but US Food and Drug Administration–recommended strategies remain acceptable.

Objective With the development of blood transfusion technology, the blood testing model is relatively decentralized, inefficient and costly in blood stations in China. Blood centralized detection not only effectively improves the quality of blood testing, but is also more cost-effective in labor and equipment.The purpose of this paper is to create a minimum cost model for blood testing that integrates the transportation cost, testing cost and center operating cost. Methods A mixed-integer planning model was developed with the annual cost of blood testing as the objective function, and sample processing capacity, sample allocation, logistic relationship between transportation and center construction, and consistency of transportation decisions with transportation volume as constraints.The empirical analysis takes Sichuan province as an example, collects data through expert interviews and research, does linear processing and adjustments to the segmented data to meet the modeling needs, and carries out modeling operations and verifies the optimal solution through python coding. Results A mixed integer programming model suitable for the number and location of centralized testing laboratories in China was developed.In the empirical analysis of Sichuan, the data required for the model was collected and the segmented data was linearized. A detailed cost analysis was conducted, revealing that the most cost-effective option was to establish centralized testing laboratories in Chengdu and Suining.The least cost-effective option identified in this study involved independent testing at 21 blood stations. Compared to this baseline, the most cost-effective strategy(establishing centralized testing laboratories in Chengdu and Suining) can reduce expenses by 29.433%. To ensure the reliability of these results, multiple rounds of validation were performed. Further analysis revealed that the strategy of establishing testing centers in Chengdu and Bazhong was a suboptimal choice, which can achieve a cost reduction of 29.431%. Conclusion This paper constructs a mixed-integer planning model for the number and location of centralized testing laboratories, which for the first time provides a decision-making basis for the location of regional centralized blood testing in China from the perspective of cost, and carries out an empirical analysis of Sichuan to develop the most cost-effective option.

Objective To analyze the reentry of single reagent reactive voluntary blood donors in our center, in order to provide data support and reference for the recall of single reagent reactive blood donors. Methods Collect the information of eligible blood donors from the information system of our center from January 2019 to September 2023 were collected, and the reentry were tracked and retrospectively analyzed. The demographic characteristics, active reentry rate, and re-donation rate of eligible blood donors were analyzed, and the differences between qualified reentry rates and factors affecting re-donation were compared using chi-square test. Results A total of 3 361 blood donors met the reentry criteria, with an active reentry rate of 2.7% (91/3 361) and a qualified reentry rate of 80.21% (73/91). The reentry rate of eligible blood donors showed significant differences in terms of different genders(3.3% vs 2.1%), educational background(3.7% vs 2.3%), blood donation frequency(9.3% vs 4.0% vs 1.3%), testing items(7.7% vs 2.7% vs 1.9% vs 1.3%) and blood donation types(18.1% vs 2.0%) (P

The article focuses on the 25-year anniversary of the Serious Hazards of Blood Transfusion (SHOT) system and provides an appraisal and commentary on its effectiveness in improving transfusion safety. It discusses key achievements of SHOT, such as the reduction of ABO-incompatible deaths and the identification of critical incidents like TRALI (Transfusion-Related Acute Lung Injury).

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jka) or without alloantibodies at evorpacept concentrations up to 2,000 μg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b−], S−s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fyb and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment. [ABSTRACT FROM AUTHOR]

Objective To explore the the potential risks of antiretroviral therapy(ART) drugs on blood safety among blood donors in Shenzhen. Methods High pressure liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) was used to measure ART drugs concentrations in the plasma of regular blood donors (negative control group, n=86) and anti-HIV positive individuals (experimental group, n=98, detected from approximately 440 000 blood donors during 2019—2023). The baseline plasma concentrations of ART drugs in the negative control group were clarified, and the impact of ART drugs on blood safety was analyzed. Results The baseline concentrations of ART drugs were not detected in 86 samples of negative control group. Four positive ART drugs samples were detected in 1∶2 pooled plasma samples of 98 anti-HIV positive blood donors plasma in the resolution test. The ART positive rate of anti-HIV positive donors was 4.08%, with tenofovir, lamivudine and efavirenz detected in three blood donors and lamivudine, lopinavir, ritonavir and zidovudine detected in one blood donor. Conclusion ART drugs were found among anti-HIV positive blood donors in Shenzhen. Additional research is needed to investigate the motivation of these specific donors, so as to ascertain the groups most susceptible to potential risks, and guarantee blood safety.

Objective To analyze the situation of regular whole blood donation in Tianjin between 2013 and 2022, in order to provide data support for improving the recruitment and retention measures of regular blood donors and ensuring safe clinical blood supply. Methods From 2013 to 2022, 185 639 regular whole blood donors in Tianjin were selected as the study group and 1 015 312 other whole blood donors in the same period were selected as the control group. The demographic data, blood collection volume and blood retest screening of blood donors in the two groups were statistically analyzed. Results The number of regular blood donors and the volume of blood donated in Tianjin increased year by year from 2013 to 2022, with an average annual growth rate of 6.22% and 6.18%, respectively. From 2013 to 2021, the retention rate of regular blood donors increased first and then decreased. The proportion of male blood donors in the study and control groups showed a decreasing trend but the proportion of female donors showed an increasing trend, with the proportion of male donors in the study group higher than that in the control group and the proportion of female donors lower than that in the control group (both P

Background and Objectives: Transfusion‐related hepatitis B infections have been reduced significantly with the implementation of blood screening using both serology and nucleic acid amplification technology (NAT) in developed countries. However, in resource‐constrained countries, where NAT is inaccessible, the risk persists from early acute and occult cases. This study aimed to determine the antibodies to hepatitis B core antigen (anti‐HBc) reactive rate among hepatitis B surface antigen (HBsAg)‐screened negative blood donors and its impact on blood safety in the Philippines. Materials and Methods: A total of 1602 HBsAg‐negative samples, randomly collected from nine leading blood service facilities representative of each region in the Philippines, were tested for anti‐HBc immunoglobulin M (IgM), Total and antibodies to HBsAg (anti‐HBs) using the Architect i2000SR Immunoassay Analyser (Abbott Laboratories, IL). Anti‐HBc IgM and/or Total repeat reactive were further tested for hepatitis B virus (HBV) NAT using the Cobas TaqScreen MPX v2.0 (Roche Diagnostics, Basel). Results: Overall, 19.16% HBsAg‐negative samples (n = 307/1602) were reactive for either anti‐HBc IgM or Total or a combination of both, of which 1.3% (n = 4/307) had detectable HBV‐DNA and 80.5% (n = 247/307) were anti‐HBs positive. About the anti‐HBs titres, 30.27% (n = 485/1602) were positive (≥10 IU/L) with 55.67% (n = 270/485) having titres ≥100 IU/L. Anti‐HBs‐only‐positive samples were 14.85% (n = 238/1602). Conclusion: We observed a high anti‐HBc reactive rate (19.16%) with 3.7% anti‐HBc‐only reactive (anti‐HBs negative) and 1.3% HBV‐DNA positive. This warrants the need to reconsider existing screening practices to improve blood safety in the country. [ABSTRACT FROM AUTHOR]

Background: Transfusion‐transmitted malaria (TTM) is a public health problem in endemic and nonendemic areas. The Brazilian Ministry of Health (MH) requested the development of a nucleic acid amplification test (NAT) for the detection of Plasmodium spp. in public blood centers to increase blood safety. Study Design and Methods: The new Brazilian NAT kit named NAT PLUS HIV/HBV/HCV/Malaria Bio‐Manguinhos was first implemented in HEMORIO, a public blood center in the city of Rio de Janeiro. Since October 1, 2022, this blood center has been testing all its blood donations for malaria in a pool of six plasma samples to detect Plasmodium spp. by real‐time polymerase chain reaction (PCR). Results: Since the implementation of the NAT PLUS platform until February 2023, HEMORIO has successfully received and tested 200,277 donations. The platform detected two asymptomatic donors in the city of Rio de Janeiro, which is a nonendemic region for malaria. Our analyses suggested a malaria from the Amazon region caused by Plasmodium vivax, in the first case, while an autochthonous transmission case by Plasmodium malariae was identified in the rural area of Rio de Janeiro state. Discussion: The NAT PLUS platform detects Plasmodium spp. in plasma samples with sensitivity capable of detecting subpatent infections. This is the first time worldwide that a group developed and implemented molecular diagnosis for Plasmodium spp. to be used by public blood centers to avoid TTM. [ABSTRACT FROM AUTHOR]

Blood transfusion is a vital procedure, where transfusion‐transmitted infection of hepatitis B virus (HBV) remains an important issue, especially from blood donors with occult hepatitis B virus infection (OBI). Occult hepatitis B virus infection is a complex entity to detect using surrogate blood biomarkers for intrahepatic viral transcriptional activity, requiring a continually refined battery of tests utilised for screening. This review aims to critically evaluate the latest advances in the current blood biomarkers to guide the identification of OBI donors and discuss novel HBV markers that could be introduced in future diagnostic practice. Challenges in detecting low HBV surface antigen levels, mutants, and complexes necessitate ultrasensitive multivalent dissociation assays, whilst HBV DNA testing requires improved sensitivity but worsens inaccessibility. Anti‐core antibody assays defer almost all potentially infectious donations but have low specificity, and titres of anti‐surface antibodies that prevent infectivity are poorly defined with suboptimal sensitivity. The challenges associated with these traditional blood HBV markers create an urgent need for alternative biomarkers that would help us better understand the OBI. Emerging viral biomarkers, such as pre‐genomic RNA and HBV core‐related antigen, immunological HBV biomarkers of T‐cell reactivity and cytokine levels, and host biomarkers of microRNA and human leucocyte antigen molecules, present potential advances to gauge intrahepatic activity more accurately. Further studies on these markers may uncover an optimal diagnostic algorithm for OBI using quantification of various novel and traditional blood HBV markers. Addressing critical knowledge gaps identified in this review would decrease the residual risk of transfusion‐transmitted HBV infection without compromising the sustainability of blood supplies. [ABSTRACT FROM AUTHOR]

Background: HIV, HBV, and HCV infections for ~60% of the US blood supply are monitored by TTIMS with syphilis added in 2020. Study Design and Methods: Data were compiled from October 2020 to September 2022. Syphilis prevalence was estimated for allogeneic and directed donors who were consensus positive (CP) and the subset of those with confirmed‐active infections (AI). Prevalence and incidence were stratified by demographics for two consecutive 1‐year periods, starting October 1, 2020 and for both years combined. Incidence was estimated for repeat donors. Associations between syphilis positivity and other infections were evaluated. Results: Among 14.75 million donations, syphilis prevalence was 28.4/100,000 donations and significantly higher during the second year compared to the first year. Overall, syphilis incidence for the two‐year period was 10.8/100,000 person‐years. The adjusted odds of a CP infection were 1.18 (95% CI: 1.11, 1.26) times higher in the second year compared to the first, and for AI, 1.22 (95% CI: 1.10, 1.35) times higher in year 2. Highest rates occurred among males, first‐time, Black, and younger (ages 18–39) donors, and those in the South US Census region. Syphilis CP donors were 64 (95% CI: 46, 89) times more likely to be HIV CP, and AI donors 77 (95% CI: 52, 114) times more likely to be HIV CP than non‐CP donors, when controlling for confounders. Summary/Conclusions: Syphilis prevalence increased over the study period mirroring national trends reported by CDC and is significantly associated with HIV CP. [ABSTRACT FROM AUTHOR]

• Patient Blood Management (PBM) is an evidence-based, multidisciplinary approach aimed at optimizing the care of patients who might need blood transfusions. • The present study aimed to assess the indicators to achieve effective enforcement of PBM at our tertiary care referral hospital. • Eleven parameters were analysed, with scores ranging from 0 to 19. The outcome was categorized as poor, satisfactory, or good. PBM metrics play a crucial role in assessing and monitoring the effectiveness of PBM programs in healthcare settings. The present study aimed to assess the indicators to achieve effective enforcement of PBM at a tertiary care referral hospital. A prospective observational study was conducted on patients admitted for elective surgery at a tertiary care referral centre. PBM metrics were developed and assessed for various parameters, including documentation, patient evaluation, blood ordering schedule, and appropriateness. Experts in transfusion medicine and haematology checked content validity. Eleven different parameters were analysed, and a score was assigned based on the performance. The outcome was categorized as poor, satisfactory, or good. The study included 612 patients meeting the inclusion criteria and recruited from Orthopaedics, General Surgery, OBG, Urology, and ENT departments. All departments completed pre-operative anaemia tests, with General Surgery and Orthopaedics conducting the most red cell transfusions. During the study, all of the blood units were used, and there was no waste. The C/T ratio was greater in the Departments of General Surgery, Urology, and Otorhinolaryngology. Pre-operative anaemia was found in 44.12% of patients, 44 patients had red cell transfusions, with 65% getting single-unit PRBC transfusions. All departments received a PBM score between 17–19, showing adequate PBM but with room for improvement. The current study utilized Patient Blood Management (PBM) metrics to critically assess the existing practices and identify the key gaps and areas for improvement in a tertiary care centre. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to estimate the incidence of reactions caused by blood donations in Iran as well as exploring three potential scenarios of the worst, moderate, and the best situations for adverse reactions among Iranian blood donations by specifying the under-reporting rate. Methods: There are two different designs; first, the ecological study was coducted to estimate the blood donation adverse effects by using the data registered in the donor vigilance part of Iranian Blood Transfusion Organization (IBTO). Second, the cross-sectional study was conducted to estimate under-reporting in the data. For the cross-sectional study, 2408 donors were selected randomly in three cities. Results: In general, based on the estimations of this study, adverse reactions to blood donation in Iran is 2%(CI 95%, 1.4-2.6%). Local and systemic reactions estimated are 1.7%(CI 95%, 1.2-2.2) and 0.3%(0.1-0.5), respectively. Based on the national report, in general, adverse reactions to blood donation in Iran is 0.5(CI 95% 0.4-0.6). Local and systemic reactions estimated are 0.38%(CI 95% 0.28-0.48) and 0.03%(0.0.02-0.04), respectively. Conclusion: Adverse reactions may vary from region to region in Iran, but in total, there is a lot of under-reporting in the incidence of adverse reactions to blood donation in Iran, most of which are related to local reactions. [ABSTRACT FROM AUTHOR]

Background. Syphilis is one of the important blood transfusion disease that has 3 stages and characterized by latency phase. The goal of this study is detection of demographic categories related to syphilis and cell-mediated immunity in denotation of gamma interferon. Methods. The study was done in the main blood bank in Thi-Qar province-Iraq during the period from January 2020 to December 2021, the demographic data including age, gender, address and occupation. The infection was diagnosed by using TPHA technique, while gamma interferon concentration was detected by ELISA technique according to the manufacturer instruction. Results. The study record low level of syphilis (0.5438%) among blood donors, high significant differences in the parameters of study, the age group 31-40 revealed high percent of infection (44%) and high percent of infection occur in male (99.7%). Also, high significant differences were recorded in distribution of infected donors according to occupation, where gainers (72.5%) represent the most infected group than others and the blood donors that inhabits urban area (70.19%) were most exposed to syphilis infections than those in rural areas. The IFN-γ level was high significance in the infected donors (19.651±9.009) when compared with the controls under (p value= 0.000). Conclusion. In brief, syphilis has low prevalence among blood donors in Iraqi community, with significant differences among categories of demographic data. The study revealed strong cell-mediated immune response in infected blood donors characterized by high levels of gamma interferon.

The aim of this study was to assess the prevalence of occult hepatitis B infection among blood donors in St. Petersburg, as well as to characterize the identified virus isolates. The study material was represented by 2800 blood plasma samples collected in 2019 from blood donors living in St. Petersburg. The ELISA study for HBV marker rate consisted of HBsAg, anti-HBs IgG, anti-HBcore IgG. HBV DNA was analyzed by nested PCR with real-time hybridization-fluorescence detection on three targets allowing to determine virus DNA at low viral load, including HBsAg-negative chronic hepatitis B. Hepatitis B serological markers were detected in 69.43% of those surveyed, HBsAg was found in 0.43% of individuals, and all of which donated blood first time. A significant excess of the anti-HBcore IgG antibodies occurrence among primary donors (15.1%) compared with repeated/regular donors (7.48%) was shown. The prevalence of virus DNA in the group was 3.14%, including 2.71% of cases in HBsAg-negative CHB. Based on phylogenetic analysis of 88 isolates, HBV subgenotypes were determined in the following order: D1 and D2, 40.91% each, D3 and A2, 9.09% each. While determining the serological subtype in detected isolates, the serotype ayw3 (52.27%) vs ayw2 (46.59%) and adw2 (10.23%) prevailed. Drug resistance mutations, including compensatory ones, were detected in six examined patients (6.82%). In all genotype D isolates, multiple amino acid substitutions were identified in the RT, SHB, MHB, LHB, and Core regions; mutations in the preCore region were detected in 21.59% samples. In the MHR of the HBV genotype D genome, twenty-six positions were identified in which amino acid substitutions occurred, and all isolates showed modifications at positions 113, 114, 131, 134, 159, 161, 168, in 76 — at position 122, in 68 — at position 127, in 36 — at position 118, in 24 — at position 128. In HBV A2 isolates, mutations T113S, S143T, Y161F were identified. Nine isolates in the preCore region showed a polymorphism including a stop codon W28*W; in five isolates the W28S substitution was shown in the same position, and the W28*S variant was found in one more sample. The high incidence of HBsAg-negative CHB cases among blood donors, as well as the predominance of HBV isolates that simultaneously carry mutations resulting in diagnostic failure of HBsAg tests and prophylactic failure of immunoglobulin or vaccines and virus reactivation, mutations that contribute to disease progression obviously pose a threat to health and require to be further examined.

Objective. To evaluate the screening of blood samples for infectious disease markers at laboratories and blood banks in Latin America per the findings of an External Quality Assessment Program (EQAP). Methods. This qualitative analysis used data from the EQAP coordinated by the Fundação Pro Sangue Hemocentro de São Paulo with the support of the Pan American Health Organization to assess the performance of blood screening for infectious diseases from 2014 to 2018 in Latin America. Each participating laboratory or blood bank received an identical blind panel with 24 blood samples with variable reactivity for all the screening parameters. Panels were processed at each participating facility and results were returned to the Fundação Pro Sangue Hemocentro de São Paulo for individual and joint analyses. Two types of discrepant results were potential failures: false positive results (FPRs) and false nonreactive results (FNRRs). Results. A total of 23 136 samples were evaluated. Global rates of FPR, FNRR, and concordant results were 0.3%, 1.0% and 98.7%, respectively. Seven FNRRs were found for HBsAg (1.0%), 12 for syphilis (2.6%), and 21 for Chagas disease (2.9%). No FNRRs were found for the HIV, HCV, and HTLV viruses. The average accuracy of all the laboratories and blood banks participating in the EQAP during the study period was 99.5% (standard deviation, 0.5%). Conclusion. The findings of this qualitative analysis are positive for blood safety in Latin America, with an average accuracy of 99.5% among the participating laboratories and blood banks. This report reflects an important improvement in blood bank serological screening EQAP-PAHO report since the 2003.

Objective To compare the supply data of red blood cells(RBCs) from 18 blood centers in China before and after the outbreak of COVID-19 during 2018 to 2021. Methods Eight indicators related to RBCs supply from 18 blood centers in China during 2018-2021 were collected retrospectively, including the storage of total amount of qualified RBCs (referred to as the total amount of storage), the distribution of total amount of RBCs (referred to as the total amount of distribution), the distribution amount of RBCs per 1 000 population (referred to as the amount of distribution per 1 000 population), the distribution amount of RBCs from 400 mL original blood per 1 000 population [referred to as the amount of distribution per 1 000 population (400 mL)], the average daily distribution amount of RBCs (referred to as the average daily distribution amount), the average daily storage amount of RBCs (referred to as the average daily storage amount), the average storage days of RBCs when distribute (referred to as the RBC storage days), and the expired amount of RBCs (referred to as the expired amount). Based on the outbreak time of COVID-19, the data of 2018 and 2019 were the pre-pandemic group, and the data of 2020 and 2021 were the post-pandemic group. Results Data on RBCs supply in 18 blood centers from 2018 to 2021(comparison of the pre-pandemic group and the post-pandemic group): the amount of distribution per 1 000 population (median 14.68 U>13.92 U) decreased, the amount of distribution per 1 000 population (400 mL) (median 10.16 U>9.21 U) decreased, and the difference was statistically significant (P99 084.08 U) decreased, the amount of distribution per 1 000 population (median 15.04 U>12.19 U) decreased, the amount of distribution per 1000 population (400 mL) (median 10.11 U>8.94 U), the average daily distribution amount(322.66 U>270.73 U) decreased and RBC storage days (median 10.50 d324.46 U), the average daily inventory (median 3 222.00 U0.00 U) decreased, the difference has statistical significance (P

During May 2018‒December 2022, we reviewed transfusion-transmitted sepsis cases in the United States attributable to polymicrobial contaminated apheresis platelet components, including Acinetobacter calcoaceticus‒baumannii complex or Staphylococcus saprophyticus isolated from patients and components. Transfused platelet components underwent bacterial risk control strategies (primary culture, pathogen reduction or primary culture, and secondary rapid test) before transfusion. Environmental samples were collected from a platelet collection set manufacturing facility. Seven sepsis cases from 6 platelet donations from 6 different donors were identified in patients from 6 states; 3 patients died. Cultures identified Acinetobacter calcoaceticus‒baumannii complex in 6 patients and 6 transfused platelets, S. saprophyticus in 4 patients and 4 transfused platelets. Whole-genome sequencing showed environmental isolates from the manufacturer were closely related genetically to patient and platelet isolates, indicating the manufacturer was the most probable source of recurrent polymicrobial contamination. Clinicians should maintain awareness of possible transfusion-transmitted sepsis even when using bacterial risk control strategies.

BackgroundThe Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply.Study design and methodsThe US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program.ResultsThe US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2).ConclusionsThe REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.

Background and Objectives: Septic transfusion reactions (STRs) occur as a result of bacterial contamination of blood or blood products, resulting in sepsis. This scoping review aimed to identify, explore and map the available literature on the STR criteria triggering the investigation of STR. Materials and Methods: Four electronic databases (MEDLINE, Web of Science, Science Direct, Embase) were searched to retrieve scientific literature reporting such criteria, published from 1 January 2000 to 5 May 2022. Grey literature was also searched from open web sources. Results: Of 1052 references identified, 43 (21 peer‐reviewed and 22 grey literature) met the eligibility criteria for inclusion and data extraction after full article screening. Of them, most (27/43, 62.79%) were found to report a single set of criteria, and only two reported four or more sets of criteria. The analysis of 66 sets of criteria collected from the selected references revealed 57 different sets. A few sets of criteria used only one sign and symptom (s/s) (12.12%, n = 8), whereas 16 sets used 7–15 s/s (n = 16/66; 24.24%). Of the total 319 occurrences of s/s associated with the 66 sets of criteria, post‐transfusion hyperthermia, body temperature increase and hypotension were the most common s/s categories. Of all the literature available, only one study tested the diagnostic accuracy of the STR criteria. Conclusion: This scoping review revealed a substantial variation in criteria used to identify suspected STR. Consequently, conducting further studies to enhance the diagnostic accuracy of these criteria, which trigger STR investigations, is imperative for advancing clinical practice. [ABSTRACT FROM AUTHOR]

Background and Objectives: The competent authority (CA) responsible for external inspections of Polish blood establishments (BEs) and supervision of the quality system is the Institute of Haematology and Transfusion Medicine (IHTM). Before the implementation of the European Blood Inspection System (EuBIS) classification of non‐compliance, the IHTM inspections were conducted according to national guidelines and the non‐compliance‐related recommendations were based on the inspectors' own experience and interpretation of the observed problems. Since 2009, IHTM inspections were already performed according to EuBIS guidelines. The study assessed the impact of the EuBIS classification on the IHTM recommendations. We assumed that the implementation of consistent assessment criteria contributed to the upgrading of the quality of BE inspections. Materials and Methods: BE‐inspection protocols; 30 from 2009 to 2010 and 61 from 2016 to 2019. Non‐compliance‐related recommendations were classified according to the seriousness of non‐compliances (critical, major, other significant, and observation) and also to the area of BE activity (documentation, organisation of work, qualification and validation, pathway from donor qualification to blood component‐issue, quality control of blood components, adverse events and reactions). Results: The recommendations mostly referred to document‐keeping and work organisation and were distributed as follows: 2009–2 critical (others unclassified), 2010–1‐13 major, 4–25 other significant and 1–7 suggestions, 2016–2019–3‐9 critical, 90–196 major, and 157–297 other significant as well as 14–22 suggestions. Conclusion: Polish BEs still require: integrated document management, analysis of IHTM recommendations, implementation of corrective and preventive measures and personnel training in identifying similar non‐compliances in other procedures. [ABSTRACT FROM AUTHOR]

• All positive viral markers in blood donors were identified in new donors. • Pre-donation laboratory screening can reduce the risk of TTI transmission by identifying infected new donors at the pre-donation phase. • Pre-donation screening program can lead to donor loss. This donor loss resulted the more effort to retain blood donors to compensate the donor loss. The risk of transfusion-transmissible infections (TTIs) remains a concern in transfusion medicine. Since the rate of infection among first-time blood donors is higher than repeated donors, strategies to enhance blood safety can focus on new donors. The aim of the study was to investigate the effect of pre-donation viral screening of new donors on blood safety. The pre-donation screening of new donors was implemented in the Kurdistan blood center. In this program, new donors who met the blood donation criteria were informed about the program and only a blood sample was donated for HBs Ag, HCV Ab, and HIV Ab testing. New donors with negative results were invited to donate blood after 12 weeks. A unit of blood was collected from eligible returned donors. Laboratory tests were performed again using the same methods. Finally, the prevalence of confirmed positive TTI results among donated blood in Kurdistan blood center was compared before and after the establishment of program. During the study, 4,434 new donors were screened for viral markers. A total of 41 new donors (0.92%, 95% CI, 0.007–0.13) had repeatedly reactive results and infection was confirmed in blood sample of 24 donors (0.54%, 95% CI, 0.003–0.008). Overall, 56% of new donors returned for blood donation. Prevalence of confirmed TTIs markers in collected blood units was 0.27% and 0 before and after implementing program, respectively. This study indicated that Pre-donation screening can reduce the risk of TTI transmission by identifying infected donors at the pre-donation phase. [ABSTRACT FROM AUTHOR]

Introduction: SARS-CoV-2 has had a negative and significant impact on global health systems, threatening the necessary blood supply for clinical transfusions. Objective: To describe the causes of rejection of blood donors during the COVID-19 pandemic. Methods: An observational, cross-sectional and retrospective study was carried out in a population of donors who attended the Blood Bank of Ramiro Prialé Prialé National Hospital, in Huancayo, Peru, from July, 2020 to the same month, 2022. The analyzed variables were sex, the ABO blood group, Rh factor and types and causes of rejection. Results: Of total of 10 177 blood donors, 3390 (33.3%) were differed and excluded; the most frequent cause of differing was the low hematocrit (18.0%) and the most frequent cause of exclusion was antibody to hepatitis B core antigen positivity (36.8%). Likewise, male sex predominated among those who were rejected (55.2%) and an increment of the polytomous tendency was evidenced in differed (R²=0.2214) and excluded donors (R²=0.1178). Conclusions: The prevalence of differing and exclusion in blood donors was relatively high compared to that reported in other studies, which was mainly due, in each respective case, to the low hematocrit and the presence of antibody to hepatitis B core antigen. [ABSTRACT FROM AUTHOR]

Background and Objectives: Until 25 July 2022, people who spent more than 6 months in the United Kingdom during the variant Creutzfeldt–Jakob disease (vCJD) risk period 1980–1996 (UK donors) were deferred from blood donation in Australia. Regulatory approval to remove the deferral was underpinned by published mathematical modelling predicting negligible vCJD transmission risk increase with a gain of 58,000 donations. Materials and Methods: The donor questionnaire retained the UK deferral screening question until a version update effective 12 February 2023, which enabled identification of the newly eligible cohort of UK donors. Their donations were tracked for a 6‐month period (25 July 2022–24 January 2023) and compared with baseline Lifeblood donation metrics and predicted gains. Results: A total of 38,462 UK donors attended to donate 78,762 times in the 6 months. Of these, 32,358 donors (females = 19,456, males = 12,902) successfully donated 67,914 times representing 8.4% of total collections. Conclusion: Cessation of the UK deferral resulted in donation gains exceeding modelled predictions because of a higher than predicted number of donors who donated at a higher rate. Had these newly eligible donors not donated, overall donation numbers would have been 88% of target rather than the 96% achieved. [ABSTRACT FROM AUTHOR]

A more individualised donor selection policy was implemented in the UK in 2021, which replaced the previous 3‐month deferral for men who have sex with men (MSM). Other blood services have a variety of policies in place to ensure the virological safety of blood components, ranging from an indefinite ban on MSM, to a defined period of exclusion, or to an individualised risk assessment that is not based on gender or sexual orientation. Justification of these policies should be based on scientific evidence including assessment of lengths of virological window periods, infectious disease epidemiology within donor populations and donation screening assay sensitivities. Developments in molecular technology and assays which can detect both antibodies and antigens in the very early stages of infection have significantly reduced the risk in most developed countries. However, the increasing usage of pre‐exposure prophylaxis (PrEP) to prevent acquisition of HIV infection after possible high‐risk sexual contact within the UK blood donor population has been recently noted. It has brought with it new diagnostic challenges within blood screening, notably possible non‐detection of HIV RNA and serological markers following PrEP use despite potential infectivity. The use of other testing strategies such as detection of HIV DNA and screening for non‐declared PrEP usage should be investigated further. [ABSTRACT FROM AUTHOR]

Blood and blood products are listed as one of the essential medicines by the World Health Organization (WHO). In addition to inadequate supply, most sub‐Saharan Africa (SSA) nations fail to meet their blood needs because many donated blood units are discarded because they are contaminated with transfusion‐transmitted infections (TTIs). We sought to estimate the prevalence of TTIs, identify the risk factors for TTIs among blood donors, and identify the efforts and interventions that have been made to improve blood safety in Southern African nations, particularly the nations of the South African Development Community (SADC). We investigated the prevalence and risk factors for TTIs, blood safety interventions, and blood quality improvement in the SADC region from major PubMed/MEDLINE, Cochrane Library, and HINARI databases from 1 January 2011 to 31 April 2021. All investigations followed the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA). In meta‐analysis, we estimated the pooled TTIs prevalence and summarised the same using forest plots. A total of 180 articles published from the SSA region were identified covering our three targeted themes: TTI prevalence, risk factors for TTIs, and blood safety improvements. Of these 180 articles, only 27 (15%) focused on the SADC region. The overall pooled TTI prevalence estimate was 2.0% (95% CI: 1.0–3.0) and hepatitis B was the most prevalent TTI in the region (prevalence = 3.0; 95% CI: 2.0–5.0). The prevalence of HIV, HCV, and syphilis was 2.0% (95% CI: 1.0–4.0), 1.0% (95% CI: 0.0–2.0), and 2.0% (95% CI: 0.0–8.0), respectively. In general, replacement donors and first‐time donors were more likely to be infected with TTIs than repeat donors. Twelve articles explored blood safety research in the region; however, they vary greatly highlighting the need for consistent and more comprehensive research. Few publications were identified that were from the SADC region, indicating lack of research or resources towards improving both quantity and quality of blood donation. TTI prevalence remains one of the highest in the world and blood safety recommendations vary across the region. More effort should be directed towards developing a cohesive regional blood transfusion policy and effective blood monitoring and evaluation strategies. [ABSTRACT FROM AUTHOR]

Background: Hepatitis B Virus (HBV), and occult Hepatitis B in particular, is a major concern in the transfusion scenario, especially in endemic countries. This study attempted to estimate the prevalence of occult Hepatitis B infection (OBI) among voluntary blood donors in Maharashtra and to evaluate the role of combined screening strategy with implications in minimizing the current transfusion risks of seropositive OBI. Methods: Donor samples were collected from 80 eligible blood banks from various districts of Maharashtra between 2014 and 2017. ELISA based screening of HBsAg, anti-HBc (total and IgM), anti-HBs titres. Real-time quantitative PCR for Hepatitis B Virus DNA (HBV DNA) were performed for all HBsAg and or anti-HBc positive samples. Results: Out of 2398 samples tested, 20 (0.83%) samples were positive for HBsAg, whereas 547 (22.81%) were positive for anti-HBc. Out of 547 samples, 16 (2.92%) were positive for HBV DNA with median level at 247.89 IU/mL (IQR: 126.05–666.67 IU/mL). Anti-HBs levels were positive in 35.83% of OBI cases. ROC curve analysis showed that combined HBsAg, anti-HBc and anti-HBs (>50 mIU/mL) screening can more efficiently detect HBV infection in blood donors than HBsAg alone. Conclusions: A combined HBsAg, anti-HBc and anti-HBs screening for donor samples could be an alternative achievable strategy to minimize the HBV transmission as well as financial burden. In resource limited setup, the proposed combined strategy could be helpful in minimizing the risk of OBI transmission.

Objective To monitor the positive rates of IgM and IgG antibodies and the changes in S/CO values over time in voluntary blood donors infected with SARS-CoV-2 after recovery, in order to provide theoretical basis and data support for ensuring clinical blood safety. Methods A total of 54 platelet donors who met the inclusion criteria were selected for this study, and 359 blood samples (plasma) from T1 to T7 (at 7 time points, spanning 14 to 15 weeks) were continuously monitored for SARS-CoV-2 IgM and IgG antibodies using fully automated chemi-luminescence method. Results Among 359 blood samples (plasma) from 54 donors, 349 were with valid test results.Eleven donors were tested positive for IgM, with a positive rate of 20.37%, and IgM antibody S/CO value gradually increased during T1-T3, but gradually decreased during T4-T7. Fifty-four donors were tested positive for IgG, with the positive rate of 100%, and the S/CO value of IgG antibody gradually decreased over time. During the period of T1 -T7, there was no significant difference in SARS-CoV-2 IgG antibody S/CO value between gender (male/female) or age group (18-39 years old /40-60 years old). Conclusion The positive rate of SARS-CoV-2 IgG antibody in platelet donors after recovery from SARS-CoV-2 infection was 100% during 2-14 weeks, and the IgG S/CO value gradually decreases over time. The long-term dynamic changes of SARS-CoV-2 serologically specific IgG and IgM antibodies in blood donors are worthy of further study.

BackgroundAlthough the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context.Study design and methodsNine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity.ResultsThe overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions.ConclusionThe safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

Abstract Background With the safety of blood transfusion being a major public health concern, the development of a rapid, sensitive, specific, and cost-effective multiplex PCR assay for simultaneous detection of hepatitis B virus(HBV), hepatitis C virus (HCV), hepatitis E virus (HEV), and Treponema pallidum(T. pallidum) in blood is crucial. Methods Five primer pairs and probes were designed towards conserved regions of target genes and used to establish a one-step pentaplex real-time reverse transcription PCR(qRT-PCR) assay for simultaneous detection of HBV, HCV, HEV, T. pallidum, and RNase P(housekeeping gene), providing sample quality check. The clinical performance of the assay was further determined with 2400 blood samples from blood donors and patients in Zhejiang province, and compared the results with commercial singleplex qPCR and serological assays. Results The 95% limit of detection(LOD) of HBV, HCV, HEV, and T. pallidum were 7.11 copies/µL, 7.65 copies/µL, 8.45 copies/µL, and 9.06 copies/µL, respectively. Moreover, the assay has good specificity and precision. Compared to the singleplex qPCR assay, the novel assay for detecting HBV, HCV, HEV, and T. pallidum presented 100% clinical sensitivity, specificity, and consistency. Several discrepant results between serological and pentaplex qRT-PCR assays were found. Of 2400 blood samples, there were 2(0.08%) HBsAg positive samples, 3(0.13%) anti-HCV positive samples, 29(1.21%) IgM anti-HEV positive samples and 6(0.25%) anti-T. pallidum positive samples proven negative in nucleic acid detection. 1(0.04%) HBV DNA positive sample and 1(0.04%) HEV RNA positive sample were detected negative by serological testing. Conclusions The developed pentaplex qRT-PCR is the first assay on simultaneous, sensitive, specific, and reproducible detection of HBV, HCV, HEV, T. pallidum, and RNase P in a single tube. It could detect pathogens in blood during the window period of infection and is a good tool for effectively screening blood donors and early clinical diagnosis.

Hepatitis E virus (HEV) is one of the main reasons of acute viral hepatitis. Although the majority of hepatitis E virus infection in humans is transmitted by fecal-oral route around the world, transfusion-transmitted HEV (TT-HEV) has attracted more and more attention as an emerging global health problem. Worldwide, 0.001 3%-0.281 0% of blood donors are HEV virus asymptomatic infection, and 0.27%-60.50% of blood donors have anti-HEV immunoglobulin antibody IgG. Blood recipient could get infected with HEV even if viral load in the blood is extremely low, which poses a great threat to blood safety. Therefore, HEV screening in blood donors has become an important concern in many countries. This article reviews the evidence and typical cases of TT-HEV, as well as the detection protocols and results of HEV screening in different countries, in order to provide evidence for whether HEV screening should be included in routine screening items for voluntary blood donors in China.

At present, many infectious pathogens, especially emerging/re-emerging pathogens, exist in the blood of voluntary blood donors and may be transmitted through blood transfusions. However, most of Chinese blood centers only routinely screen for HBV, HCV, HIV, and syphilis. We employed metagenomic next-generation sequencing (mNGS) to investigate the microbiome in healthy voluntary blood donors to help assess blood safety in China by identifying infectious pathogens presented in donations that could lead to transfusion-acquired infections. We collected 10,720 plasma samples from voluntary blood donors from seven blood centers in different cities during 2012–2018 in China. A total of 562 GB of clean data was obtained. By analyzing the sequencing data, it was found that the most commonly identified bacteria found in the healthy blood were Serratia spp. (5.0176%), Pseudomonas spp. (0.6637%), and Burkholderia spp. (0.5544%). The principal eukaryote were Leishmania spp (1.3723%), Toxoplasma gondii (0.6352%), and Candida dubliniensis (0.1848%). Among viruses, Human Parvovirus B19 (B19V) accounts for the highest proportion (0.1490%), followed by Torque teno midi virus (0.0032%) and Torque teno virus (0.0015%). Since that B19V is a non-negligible threat to blood safety, we evaluated the positive samples for B19V tested by mNGS using quantitative polymerase chain reaction, Sanger sequencing, and phylogenetic analysis to achieve a better understanding of B19V in Chinese blood donors. Subsequently, 9 (0.07%) donations were positive for B19V DNA. The quantitative DNA levels ranged from 5.58 × 102 to 7.24 × 104 IU/ml. The phylogenic analyses showed that prevalent genotypes belonged to the B19-1A subtype, which disclosed previously unknown regional variability in the B19V positivity rate. The investigation revealed that many microbes dwell in the blood of healthy donors, including some pathogens that may be dormant in the blood and only cause disease under specific conditions. Thus, investigating the range and nature of potential pathogens in the qualified donations provided a framework for targeted interventions to help prevent emerging and re-emerging infectious diseases.

Objectives: This study evaluated the Human T‐lymphotropic virus (HTLV) screening policy impact on the HTLV seroprevalence from 2009 to 2018 as well as the differences between administrative districts in terms of prevalence distribution in Taiwan. Background: Since February 1996, the Taiwan Blood Services Foundation (TBSF) had conducted HTLV screening of blood donors. The HTLV seroprevalence was 0.032% in 1999. Materials and Methods: This cross‐sectional study included donors' data collected from blood donation centres across Taiwan from 2009 to 2018. Enzyme immunoassay and Western blot assay were used for screening and confirmation of HTLV infections. In this study, the researchers calculated the trends in the HTLV rates of first‐time and repeat donors across time as well as the HTLV prevalence distribution across the 22 administrative districts of Taiwan. Results: Amongst 17 977 429 employed blood donations, 739 HTLV‐seropositive donations (4.11 per 100 000 donations) were identified. The HTLV‐positive donors were aged between 17 and 64 years, with a median age of 49 years. The overall seropositivity rates of first‐time and repeat donors were 34.36/100 000 and 1.27/100 000. HTLV seroprevalence in first‐time blood donors significantly decreased by 57% (crude odds ratio [95% confidence interval] (crude OR [95% CI]) = 0.43 [0.28–0.64]) within 10 years. A slight decline was also identified in repeat donors (crude OR [95% CI] = 0.73 [0.4–1.32]). Donors from different districts showed significantly varied prevalence. Most districts with high prevalence are situated in eastern Taiwan, for both donation types. Older blood donors were more likely to be infected with HTLV than younger ones in first time and repeat donors. Middle age donors (50–65 years) had an 18.47–39.65 greater risk than those aged <20 years. Significant higher risk of female was observed in both donation types. Amongst different age groups, first‐time female donors increase 1.31–1.88 times infection risk and female in repeat donor group had 1.55–3.43 times greater risk. Conclusion: Over years of implementation of the HTLV blood donor screening policy by the TBSF, the HTLV seroprevalence of first‐time donors has decreased consistently. Moreover, the HTLV seroprevalence of repeat donors has dropped considerably. This implies that the screening policy provides continued benefit. Females and older blood donors were more likely infected with HTLV than males and younger blood donors. The influence of age on infection was greater amongst first‐time donors than amongst repeat donors. Therefore, appropriate measures should be taken to ensure public safety. [ABSTRACT FROM AUTHOR]

Background: Transfusion‐transmitted bacterial infections (TTBIs) in Japan have been largely prevented due to a short shelf life of 3.5 days after blood collection for platelet concentrate (PC) and washed PCs (WPCs; PC in which 95% plasma is replaced by platelet additive solution). Case Presentation: Case 1: In January 2018, a woman in her 50s with aplastic anaemia who received WPC transfusion and developed a fever the next day and Streptococcus dysgalactiae subspecies equisimilis (SDSE) was detected in the residual WPC. Case 2: In May 2018, a man in his 60s with a haematologic malignancy who received PC transfusion and developed chills during the transfusion. SDSE was detected in the patient's blood and residual PC. The contaminated platelet products were both manufactured from blood donated by the same donor. The multi‐locus sequencing typing revealed that SDSE detected in case 1 was identical to that from case 2; however, whole blood subsequently obtained from the donor was culture negative. Conclusion: WPC and PC produced from two blood donated 106 days apart by the same donor were contaminated with SDSE of the same strain and both caused TTBIs. Safety measures should be considered regarding blood collection from a donor with a history of bacterial contamination. [ABSTRACT FROM AUTHOR]

Transfusion medicine resembles all of medicine in that expert opinion predominates because hard data on clinical outcomes from randomized controlled trials and high quality observational data are simply unavailable. Indeed, some of the first trials evaluating important outcomes are barely two decades old. Patient blood management (PBM) depends on high quality data for assisting clinicians in making clinical decisions. In this review, we focus on several red blood cell (RBC) transfusion practices that new data suggest need reconsideration. The practices that may need revision include transfusion for iron deficiency anaemia, except in life threatening situations, toleration of anaemia as a largely benign condition and use of haemoglobin/haematocrit as primary indications for RBC transfusion, as opposed to adjuncts to clinical judgement. In addition, the long‐standing notion that the minimum transfusion should be two units needs to be abandoned due to the danger to patients and a lack of clinical evidence of benefit. Finally, the difference in indications for leucoreduction versus irradiation needs to be understood by all practitioners. PBM is one of the strategies for managing anaemia and bleeding that holds great promise for patients, and transfusion is only one facet of the bundle of practices. [ABSTRACT FROM AUTHOR]