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Emerging practices in the estimation of hemoglobin measurement uncertainty in blood establishments. 血液机构中血红蛋白测量不确定度估算的新兴实践。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-31 DOI: 10.1016/j.transci.2026.104401
Maria Helena Sousa Timóteo, Ana Sofia R Tavares, Paulo Pereira

Measurement uncertainty (MU) is increasingly recognized as a critical analytical parameter within ISO and European regulatory frameworks. In transfusion laboratories, where hemoglobin testing determines donor eligibility and informs transfusion decisions, MU directly impacts patient and donor safety. This study applies ISO/TS 20914:2019 to estimate MU in hemoglobin testing using the cyanmethemoglobin method in EDTA-K3 venous blood. A parametric simulation model informed by EFLM biological variation data was used to evaluate three scenarios: (1) within-laboratory imprecision, (2) addition of calibrator uncertainty, and (3) incorporation of significant bias uncertainty. All scenarios met desirable (2.7 %) and minimum (4.1 %) performance targets for allowable uncertainty. These findings reinforce the integration of MU estimation as a European and ISO-endorsed best practice in transfusion laboratory medicine. This approach supports traceable, risk-informed decision-making, aligning transfusion services with ISO 15189:2022 requirements.

测量不确定度(MU)越来越被认为是ISO和欧洲监管框架中的关键分析参数。在输血实验室,血红蛋白检测决定供者的资格并为输血决策提供信息,MU直接影响患者和供者的安全。本研究采用ISO/TS 20914:2019方法对EDTA-K3静脉血中血红蛋白检测中的MU进行估算。基于EFLM生物变异数据的参数化模拟模型用于评估三种情况:(1)实验室内不精度,(2)添加校准器不确定性,以及(3)纳入显著偏差不确定性。对于允许的不确定性,所有场景都满足理想的(2.7 %)和最小的(4.1 %)性能目标。这些发现加强了MU评估作为欧洲和iso认可的输血实验室医学最佳实践的整合。这种方法支持可追溯的、风险知情的决策,使输血服务符合ISO 15189:2022的要求。
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引用次数: 0
Apheresis in Ethiopia: Availability, challenges, and opportunities. 埃塞俄比亚的血液透析:可用性、挑战和机遇。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-31 DOI: 10.1016/j.transci.2026.104396
Ashenafi Tazebew Amare

Apheresis, the selective removal or collection of blood components, has become an essential pillar of modern transfusion medicine, serving both donor and therapeutic purposes. While high-income countries have achieved wide adoption of automated apheresis for component collection and disease management, its use in Africa, including Ethiopia, remains limited. In Ethiopia, apheresis services are confined to a few facilities within the Ethiopian Blood and Tissue Bank Service (EBTBS) and select private institutions. Key challenges include inadequate infrastructure, unreliable supply chains, a shortage of trained personnel, the absence of national standards, and inadequate reimbursement mechanisms. Equipment maintenance difficulties, inconsistent power supply, and low clinical awareness further restrict utilization. Despite these constraints, significant opportunities are emerging. Ongoing national policy and institutional reforms, expanding healthcare investments, and integration with organ transplantation and regenerative medicine programs provide a strong foundation for scaling up services. Regional and international partnerships with organizations such as the World Health Organization, African Society of Blood Transfusion, and International Society of Blood Transfusion, along with advancements in digital health and research, can enhance capacity, traceability, and quality. Expanding apheresis capacity in Ethiopia presents a strategic opportunity to strengthen transfusion medicine, improve clinical outcomes, and build a resilient and sustainable blood system aligned with global standards.

血液分离,选择性地去除或收集血液成分,已成为现代输血医学的重要支柱,既服务于供体目的,也服务于治疗目的。虽然高收入国家已广泛采用自动采血进行成分收集和疾病管理,但其在非洲(包括埃塞俄比亚)的使用仍然有限。在埃塞俄比亚,采血服务仅限于埃塞俄比亚血液和组织库服务(EBTBS)内的一些设施和一些私人机构。主要挑战包括基础设施不足、供应链不可靠、训练有素的人员短缺、缺乏国家标准和不充分的报销机制。设备维修困难、供电不稳定、临床意识不高,进一步制约了设备的利用。尽管存在这些限制,但重大机会正在出现。正在进行的国家政策和体制改革、扩大医疗保健投资以及与器官移植和再生医学项目的整合为扩大服务提供了坚实的基础。与世界卫生组织、非洲输血协会和国际输血协会等组织建立的区域和国际伙伴关系,以及数字卫生和研究方面的进展,可以增强能力、可追溯性和质量。扩大埃塞俄比亚的采血能力为加强输血医学、改善临床结果和建立符合全球标准的有弹性和可持续的血液系统提供了一个战略机遇。
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引用次数: 0
The case against infusing ABO incompatible antibody and antigen from all blood components. 本病例反对输注ABO不相容抗体和来自所有血液成分的抗原。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-31 DOI: 10.1016/j.transci.2026.104402
Nicholas Tong, Debra Masel, Phuong-Lan Nguyen, Akua Asante, Majed Refaai, Joanna M Heal, Neil Blumberg

The transfusion of ABO compatible but not ABO identical red blood cells and plasma and the transfusion of platelets and cryoprecipitate without concern for ABO in any manner, are practices that have been accepted as safe for patients. While these practices make managing blood component inventories easier by reducing component outdating, they do lead to the development of immune complexes, donor antibody induced hemolysis, and potentially endothelial cell and platelet injury. A growing body of evidence has shown that these practices are associated, likely causally, with negative consequences for patients including increased mortality. The adoption of a policy of providing only ABO identical blood components when practical, and avoiding infusion of ABO incompatible antibody, cellular and soluble antigen should thus become the optimal standard of care for patients.

输注ABO相容但非ABO相同的红细胞和血浆,以及输注血小板和冷沉淀而不考虑ABO的任何方式,已被认为是对患者安全的做法。虽然这些做法通过减少成分过时使管理血液成分库存更容易,但它们确实导致免疫复合物的发展,供体抗体诱导的溶血,以及潜在的内皮细胞和血小板损伤。越来越多的证据表明,这些做法可能与患者的负面后果有关,包括死亡率增加。因此,在可行的情况下,采取只提供ABO相同血液成分的政策,避免输注ABO不相容的抗体、细胞和可溶性抗原,应成为患者的最佳护理标准。
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引用次数: 0
A low dose is better than no dose: Is it time to consider lowering the US minimum plateletpheresis yield? 低剂量比无剂量好:是时候考虑降低美国最低血小板穿刺率了吗?
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-30 DOI: 10.1016/j.transci.2026.104389
Ludwig Frontier, Alyssa Ziman, Barbara J Bryant, Manish J Gandhi, Ruchika Goel, Jeffrey Hebert, Tina Ipe, Patricia Kopko, Kathleen Rowe, Roxane Smith, Yanyun Wu, Richard Gammon

Maintaining an adequate platelet supply in the United States (US) has become increasingly challenging due to stringent regulatory requirements, diminishing donor availability, and expanding clinical demand. Current US regulations require a minimum apheresis platelet yield of 3.0 × 10 ¹ ¹ per unit, a standard substantially higher than those used internationally. Implementation of bacterial risk mitigation strategies has further increased the proportion of plateletpheresis collections falling below this threshold, resulting in low-yield platelet units becoming a structurally important component of the national inventory. Analysis of US platelet utilization from 2022 to 2024 demonstrates that despite persistent supply pressures, the proportion of low-yield units remained relatively stable, while dividing of platelet units declined. Evidence from clinical studies indicates that low-yield platelets provide hemostatic efficacy comparable to standard-yield components in thrombocytopenic patients with marrow failure. However, single-center observations suggest an increase in overall platelet utilization when lower-yield units represent a larger proportion of available inventory, highlighting the influence of transfusion practices on product demand. Given ongoing supply constraints, the established availability of low-yield components, and international experience demonstrating safe use at lower minimum thresholds, reconsideration of the current US minimum plateletpheresis yield requirement is warranted. Harmonizing regulatory standards with global practice has the potential to enhance platelet availability, reduce donor burden, and strengthen national supply resilience without compromising patient safety. Further studies are needed to assess outcomes across diverse patient populations.

在美国,由于严格的监管要求、供体数量的减少和临床需求的扩大,维持足够的血小板供应变得越来越具有挑战性。目前美国法规要求最低单采血小板产率为3.0 × 10 ¹ ¹/单位,这一标准大大高于国际上使用的标准。细菌风险缓解战略的实施进一步增加了血小板采集低于这一阈值的比例,导致低产量血小板单位成为国家库存中结构上重要的组成部分。对2022 - 2024年美国血小板利用率的分析表明,尽管供应压力持续存在,但低产量单位的比例保持相对稳定,而血小板单位的划分则有所下降。来自临床研究的证据表明,在骨髓衰竭的血小板减少患者中,低产量血小板提供的止血效果与标准产量成分相当。然而,单中心观察表明,当低产量单位占可用库存的较大比例时,总体血小板利用率增加,突出了输血做法对产品需求的影响。考虑到持续的供应限制,低产量成分的现有可用性,以及国际经验证明在较低的最低阈值下安全使用,有必要重新考虑目前美国的最低血小板提取产量要求。将监管标准与全球实践相协调,有可能提高血小板可得性,减轻供体负担,并在不损害患者安全的情况下加强国家供应弹性。需要进一步的研究来评估不同患者群体的结果。
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引用次数: 0
The fifty-year journey of apheresis platelet collection at The Western Cape Blood Service, South Africa. 南非西开普血液中心采血小板的50年历程。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-30 DOI: 10.1016/j.transci.2026.104394
Caroline Hilton, Thembie Sitsila, Kay Abrahams
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引用次数: 0
Status of donor and clinical apheresis across the African continent: A report of a 2025 survey. 非洲大陆献血者和临床采血现状:2025年调查报告
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-30 DOI: 10.1016/j.transci.2026.104392
Tanya Nadia Glatt, Thabo Gcayiya, Willem van der Merwe, Miriam Zuze, Nyankoye Haba, Dils Joh-Teye, Chandapiwa Kefilwe, Stephen Njolomole, Zakana Gabriel, Joseph Charles, Loveness Mondwa, Carla van Zyl, Ashenafi Tazebew Amare, Saliou Diop, Mohammed Farouk, Hans Vrielink

Background: Data on apheresis services in Africa are limited, despite increasing clinical demand and persistently low blood donation rates across the continent. This study assessed the current availability, use, and challenges of donor and clinical apheresis services in African countries.

Methods: A structured electronic survey was distributed in 2025 to transfusion services and relevant stakeholders in all 54 African countries. Contacts were identified through online searches and professional networks. Responses were analyzed to determine the status of apheresis practices.

Results: Contacts were obtained for 38 countries, and 12 responded (32 %). Donor platelet and plasma apheresis were performed in 67 % and 50 % of responding countries, with all others planning implementation. Reported challenges included limited trained staff, equipment breakdowns, consumable shortages, donor recruitment difficulties, and financial constraints. Clinical apheresis services were available in 50 % of responding countries, while CD34⁺ cell collection was reported only in Senegal and South Africa. Key barriers included high costs, inadequate infrastructure, shortages of consumables, and limited clinician awareness.

Conclusions: Apheresis services are emerging across Africa but remain constrained by financial, technical, and personnel limitations. Investments in infrastructure, training, and service sustainability are essential to expand access to both donor and clinical apheresis.

背景:尽管整个非洲大陆的临床需求不断增加且献血率持续较低,但非洲采血服务的数据有限。本研究评估了目前非洲国家供体和临床采血服务的可得性、使用情况和挑战。方法:在2025年对所有54个非洲国家的输血服务和相关利益相关者进行结构化电子调查。联系人是通过在线搜索和专业网络确定的。对反馈进行分析,以确定采血实践的现状。结果:获得了38个国家的联系,其中12个答复(32% %)。67% %和50% %的答复国家进行了供体血小板和血浆分离,所有其他国家都在计划实施。报告的挑战包括训练有素的工作人员有限、设备故障、消耗品短缺、捐助者征聘困难和财政限制。50%( %)的答复国家提供临床采血服务,而CD34 +细胞收集仅在塞内加尔和南非报告。主要障碍包括成本高、基础设施不足、耗材短缺和临床医生认识有限。结论:采血服务正在非洲各地兴起,但仍受到资金、技术和人员限制的制约。对基础设施、培训和服务可持续性的投资对于扩大供体和临床采血的可及性至关重要。
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引用次数: 0
Milestones in history of transfusion medicine. 输血医学史上的里程碑。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-30 DOI: 10.1016/j.transci.2026.104388
Zdravko Kvržić

Introduction: The history of transfusion medicine is vast and diverse. From its humble beginnings with animal-to-animal transfusions, followed by animal-to-human transfusions, and the first human-to-human transfusions, through the discovery of blood groups to today's highly developed quality systems, it has proven to be an important and independent field of medicine that supports other medical specialties such as surgery, transplantation, and trauma. Each period of this fascinating history is significant, with experts who worked to improve and find new ways to ensure the safe supply of blood to patients.Transfusion medicine continues to evolve, aiming to achieve the highest quality standards and foster new developments and discoveries. Its primary goal is to maintain a safe, uncontaminated supply of blood, blood components, and blood products through a sufficient number of healthy blood donors. The purpose of this article is to present the most important highlights in transfusion medicine.

Methods: This study is based on a review of literature and historical documents from the 15th to the 21st century.

Conclusion: The history of transfusion medicine is fascinating and essential for understanding the background of this noble and important field of medicine.

输血医学的历史是广泛而多样的。从最初的动物对动物输血,到后来的动物对人输血,再到第一次人对人输血,再到血型的发现,再到今天高度发达的质量体系,输血已被证明是一个重要而独立的医学领域,为外科、移植和创伤等其他医学专业提供支持。在这段引人入胜的历史中,每一段时期都意义重大,专家们都在努力改进和寻找新的方法,以确保向患者安全供应血液。输血医学不断发展,旨在达到最高质量标准,促进新的发展和发现。其主要目标是通过足够数量的健康献血者维持安全、不受污染的血液、血液成分和血液制品供应。本文的目的是介绍输血医学中最重要的亮点。方法:本研究以15世纪至21世纪的文献和历史文献为基础。结论:输血医学的历史引人入胜,对了解这一崇高而重要的医学领域的背景至关重要。
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引用次数: 0
Response to "Immune hemolytic anemia attributed to Tacrolimus: Diagnostic labeling and transfusion risk in post-transplant settings" 对“他克莫司引起的免疫性溶血性贫血:移植后诊断标签和输血风险”的回应
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.transci.2026.104378
Bowei Cao, Yanhong Bu, Yongjun Wang, Ningjie Zhang
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引用次数: 0
Clinical study of recombinant human thrombopoietin in platelet engraftment following autologous hematopoietic stem cell transplantation 重组人血小板生成素在自体造血干细胞移植后血小板植入中的临床研究
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.transci.2026.104375
Shunsen Wang , Jie Ji , Hai Yi , Lei Ma , Xiaodong Liu , Lan Li , Shan Luo , Fang Hua , Kun Chen , Jian Xiao

Background

Autologous transplantation is an effective treatment for hematological malignancies. However, post-transplant thrombocytopenia is a common complication. This study evaluated the efficacy and safety of recombinant human thrombopoietin (rhTPO) in promoting platelet engraftment following autologous hematopoietic stem cell transplantation (ASCT).

Methods

A prospective, multicentre, single-arm study screened patients for ASCT at three centers. rhTPO was administered from day +3 to +7 post-ASCT until platelet engraftment. Efficacy was assessed by time to platelet and neutrophil engraftment and platelet transfusion needs. Safety was evaluated via adverse events, hepatic/renal function, and electrolyte balance.

Results

In 63 patients, the median platelet engraftment time was 11 days (range: 8–22) and leukocyte engraftment 9 days (range: 7–15). Pre-transplant platelet count (HR=1.01, P = 0.003) and CD34+ cell dose (HR=1.42, P = 0.008) were independent predictors of platelet engraftment. Furthermore, baseline platelet count ≥ 180 × 10⁹/L and CD34+ cell dose >4.46 × 10⁶/kg reduced engraftment time (P < 0.05). Lymphoma patients required more platelet transfusions (P = 0.002). The non-Chi-CGB group demonstrated higher red blood cell and platelet transfusion volumes (P = 0.042, P = 0.002). Adverse events included elevated transaminases (11.1 %), elevated bilirubin (14.3 %), and thrombosis (1.6 %). The primary adverse bleeding events included skin ecchymosis (25.4 %) and gastrointestinal hemorrhage (4.7 %).

Conclusion

It has been demonstrated that rhTPO promotes platelet engraftment in ASCT for hematological malignancies, exhibiting a favorable safety profile. Pre-transplant platelet counts ≥180 × 10⁹/L and CD34+ cell doses >4.46 × 10⁶/kg predict faster platelet engraftment.
背景自体移植是治疗恶性血液病的有效方法。然而,移植后血小板减少是一种常见的并发症。本研究评估了重组人血小板生成素(rhTPO)促进自体造血干细胞移植(ASCT)后血小板植入的有效性和安全性。方法一项前瞻性、多中心、单臂研究在三个中心筛选ASCT患者。从asct后第3天至第7天给予rhTPO,直至血小板植入。通过血小板和中性粒细胞植入时间以及血小板输注需求来评估疗效。通过不良事件、肝肾功能和电解质平衡来评估安全性。结果63例患者中位血小板植入时间为11天(范围8 ~ 22天),白细胞植入时间为9天(范围7 ~ 15天)。移植前血小板计数(HR=1.01, P = 0.003)和CD34+细胞剂量(HR=1.42, P = 0.008)是血小板植入的独立预测因子。此外,基线血小板计数≥ 180 × 10⁹/L和CD34+细胞剂量>;4.46 × 10⁶/kg减少了植入时间(P <; 0.05)。淋巴瘤患者需要更多的血小板输注(P = 0.002)。非chi - cgb组红细胞和血小板输注量较高(P = 0.042,P = 0.002)。不良事件包括转氨酶升高(11.1 %)、胆红素升高(14.3 %)和血栓形成(1.6 %)。主要的不良出血事件包括皮肤淤斑(25.4% %)和胃肠道出血(4.7% %)。结论rhTPO促进恶性血液病ASCT中血小板植入,具有良好的安全性。移植前血小板计数≥180 × 10⁹/L和CD34+细胞剂量>;4.46 × 10⁶/kg预示血小板植入更快。
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引用次数: 0
Letter to the Editor "Immune hemolytic anemia attributed to Tacrolimus: Diagnostic labeling and transfusion risk in post-transplant settings". 致编辑的信“他克莫司引起的免疫性溶血性贫血:移植后诊断标签和输血风险”。
IF 1.2 4区 医学 Q4 HEMATOLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.transci.2026.104377
Ying Du, Hongjia Fan
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引用次数: 0
期刊
Transfusion and Apheresis Science
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