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Real-world performance of a clinical droplet digital polymerase chain reaction assay for non-invasive foetal blood group and platelet antigen genotyping of alloimmunized pregnant women with antibodies directed against RhD, RhE, Rhc, RhC, K1, HPA-1a or HPA-5b: A 1-year experience. 使用针对RhD、RhE、Rhc、Rhc、K1、HPA-1a或HPA-5b的抗体进行同种异体免疫孕妇的无创胎儿血型和血小板抗原基因分型的临床液滴数字聚合酶链反应试验的实际表现:1年的经验。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-12-08 DOI: 10.1111/vox.13777
Camilla Calandrini, Onno J H M Verhagen, Ahmed Tissoudali, Christa H E Homburg, Jessica Vessies, Mark Brussee, Erik H van Beers, C Ellen van der Schoot, Masja de Haas

Background and objectives: To test the performance of a new droplet digital polymerase chain reaction (ddPCR) non-invasive foetal blood group and platelet antigen genotyping assay in the setting of a Dutch reference laboratory for foetal blood group and platelet antigen genotyping. Our population comprised 229 consecutive alloimmunized pregnant women who presented between April 2022 and March 2023 with 250 requests for non-invasive foetal RHD, RHE, RHc, RHC, K1, HPA-1a or HPA-5b blood group and platelet antigen genotyping.

Materials and methods: Samples were genotyped for blood group and platelet antigen alleles along with methylated RASSF1a (mRASSF1a) and sex-determining region of Y (SRY) and DYS14 as positive foetal controls. Negative blood group and platelet antigen results were issued only when foetal controls were positive; otherwise, such samples were classified as inconclusive.

Results: The assay achieved a success rate of 98.4% (246 of 250) because one case was lost to follow-up, one case was solved with quantitative polymerase chain reaction (qPCR) and one case precluded foetal typing due to RHD variant mothers. Only 10 cases needed a second sample and one case a third for a valid final result. We identified 116 maternal-foetal blood group and platelet antigen incompatibilities.

Conclusion: Clinical non-invasive foetal blood group and platelet antigen typing of alloimmunized pregnant women via ddPCR is successful and represents an improvement over qPCR because of the addition of a foetal control and because ddPCR circumvents potential interference from maternal cell-free DNA (cfDNA) background for foetal HPA-1 and K1.

背景与目的:在荷兰某胎儿血型与血小板抗原基因分型参比实验室中,检测新型液滴数字聚合酶链反应(ddPCR)无创胎儿血型与血小板抗原基因分型检测方法的性能。我们的人群包括229名在2022年4月至2023年3月期间连续接受同种免疫的孕妇,其中250名要求进行非侵入性胎儿RHD、RHE、RHc、RHc、K1、HPA-1a或HPA-5b血型和血小板抗原基因分型。材料和方法:对样本进行血型和血小板抗原等位基因的基因分型,并将甲基化的RASSF1a (mRASSF1a)和Y基因性别决定区(SRY)和DYS14作为阳性胎儿对照。阴性血型和血小板抗原结果只有在胎儿对照阳性时才会公布;否则,这些样本被归类为不确定。结果:1例失访,1例用定量聚合酶链反应(qPCR)解决,1例因RHD变异母亲而排除胎儿分型,检测成功率为98.4%(246 / 250)。只有10例需要第二次采样,1例需要第三次采样才能获得有效的最终结果。我们鉴定了116例母胎血型和血小板抗原不相容。结论:通过ddPCR进行同种异体免疫孕妇的临床无创胎儿血型和血小板抗原分型是成功的,并且由于ddPCR增加了胎儿对照,并且由于ddPCR规避了母体游离DNA (cfDNA)背景对胎儿HPA-1和K1的潜在干扰,因此比qPCR有改进。
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引用次数: 0
Has the switch to sexual risk behaviour screening impacted deferrals for pre- and post-exposure prophylaxis therapy for human immunodeficiency virus? 改用性风险行为筛查是否影响了人类免疫缺陷病毒暴露前和暴露后预防治疗的推迟?
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-11-21 DOI: 10.1111/vox.13773
Mindy Goldman, Samra Uzicanin, Sheila F O'Brien

Background and objectives: Canadian Blood Services defers donors during and for 4 months after oral pre-exposure or post-exposure prophylaxis (PrEP/PEP) for human immunodeficiency virus (HIV) because of concerns about altered viral kinetics. We assessed the impact of the switch from a time-based deferral for men who have sex with men (MSM) to sexual risk behaviour criteria on PrEP/PEP deferrals.

Materials and methods: Data on PrEP/PEP deferral codes were extracted from our National Epidemiology Database for the 22 months before (Period 1) and after (Period 2) the criteria change.

Results: PEP deferrals remained stable (2.3 vs. 1.7 per 100,000 donations in Periods 1 and 2, p = 0.2892), about 45% and 33%, respectively, of these donors who reported a recent needle stick injury. PrEP deferrals increased from 5.9 to 12.4 per 100,000 (p = 0.0001); approximately 30% of donors in both periods had other HIV risk factor deferrals. Donors deferred for PrEP use alone were more likely to be male, first-time users and younger than other donors.

Conclusion: The switch to sexual risk behaviour led to a small increase in deferrals for PrEP. We may not be measuring the full impact of deferral criteria because potential donors may self-defer and PrEP use is increasing.

背景和目的:由于担心病毒动力学的改变,加拿大血液服务机构在口服暴露前或暴露后预防(PrEP/PEP)治疗人类免疫缺陷病毒(HIV)期间和之后的 4 个月内推迟捐献者。我们评估了男男性行为者(MSM)从基于时间的推迟标准转变为性危险行为标准对 PrEP/PEP 推迟的影响:我们从全国流行病学数据库中提取了标准变更前(第一阶段)和标准变更后(第二阶段)22 个月的 PrEP/PEP 延期代码数据:PEP推迟率保持稳定(第 1 和第 2 阶段,每 100,000 例捐献中,PEP 推迟率分别为 2.3 和 1.7,p = 0.2892),其中约 45% 和 33% 的捐献者报告最近曾被针刺伤。每 10 万人中因 PrEP 而推迟捐献的人数从 5.9 人增加到 12.4 人(p = 0.0001);在这两个时期中,约有 30% 的捐献者因其他 HIV 危险因素而推迟捐献。与其他捐献者相比,仅因使用 PrEP 而被推迟的捐献者更有可能是男性、首次使用者和年轻人:结论:性风险行为的转变导致因 PrEP 而推迟捐献的人数略有增加。我们可能无法衡量推迟标准的全部影响,因为潜在捐献者可能会自我推迟,而且 PrEP 的使用也在增加。
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引用次数: 0
Securing commitment and control for the supply of plasma derivatives for public health systems. I: A short review of the global landscape. 确保对公共卫生系统血浆衍生物供应的承诺和控制。I:全球形势简评。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-10-30 DOI: 10.1111/vox.13758
Leni von Bonsdorff, Albert Farrugia, Fabio Candura, Peter O'Leary, Miguel A Vesga, Vincenzo De Angelis

The social market economies of the Western world considered the provision of plasma derivatives produced from publicly owned blood services as a legitimate state commitment and, until the last decades of the 20th century, many of the relevant jurisdictions maintained state-supported fractionation plants to convert publicly collected plasma into products for the public health system. This situation started to change in the 1990s, because of several converging factors, and currently, publicly owned/subsidized, not-for-profit fractionation activity has shrunk to a handful of players. However, the collection of plasma from publicly owned blood services has continued and recent developments have increased the interest of state authorities globally to increase the volume of plasma collected to increase the level of strategic independence in the supply of crucial plasma-derived medicines from commercial market pressures, particularly the global for-profit fractionation sector with its dominance of source plasma from paid donors in the United States. This paper reviews the development of the plasma industry and the evolution of the pressures on the supply of plasma, which has led to a situation of scarcity of key plasma-derived medicinal products (PDMPs).

西方世界的社会市场经济将提供由公有血液服务生产的血浆衍生物视为合法的国家承诺,直到 20 世纪最后几十年,许多相关司法管辖区一直维持着由国家支持的分馏工厂,将公共采集的血浆转化为产品提供给公共卫生系统。这种情况在 20 世纪 90 年代开始发生变化,原因有几个方面,目前,公有/补贴的非营利分馏活动已缩减到少数几家。然而,从公有血液服务机构采集血浆的活动仍在继续,最近的发展使全球各国政府当局更有兴趣增加血浆采集量,以提高重要血浆衍生药物供应的战略独立水平,使其免受商业市场压力的影响,特别是在美国,全球营利性分馏部门在有偿捐献者来源血浆方面占据主导地位。本文回顾了血浆行业的发展和血浆供应压力的演变,这种压力已导致关键血浆衍生药物(PDMP)的稀缺。
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引用次数: 0
Agreement of point-of-care and laboratory lactate levels among trauma patients and association with transfusion. 创伤患者护理点和实验室乳酸水平的一致性以及与输血的关系。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-11-20 DOI: 10.1111/vox.13770
Biswadev Mitra, Madison Essery, Abha Somesh, Carly Talarico, Alexander Olaussen, David Anderson, Benjamin Meadley

Background and objectives: In the setting of trauma and suspected critical bleeding, indications to commence blood transfusions remain unclear, with high rates of potentially avoidable transfusions. Prehospital blood lactate measurements could help predict the need for blood transfusions. The aim of this study was to compare measurements detected by a point-of-care (POC) lactate device with laboratory measured lactate levels.

Materials and methods: This was a cross-sectional study conducted in the emergency department. Eligible patients were those with suspected major trauma and critical bleeding. Venous or arterial blood samples were collected. POC measurements of lactate levels were conducted using a StatStrip Xpress® lactate meter and compared with laboratory values.

Results: Among 70 patients, the mean difference between the POC and laboratory lactate results was -0.19 mmol/L, with limits of agreement at -1.9 and 1.5. Most measurements (n = 66; 94.3%) were within the limits of agreement. A POC lactate level of >3.3 mmol/L had >90% specificity for transfusion, whereas a level <1.4 mmol/L had 90% sensitivity to rule out a transfusion.

Conclusion: The level of agreement of POC lactate with the laboratory lactate was high. Research on clinical decision rules for pre-hospital transfusion that incorporate POC lactate measures is therefore feasible.

背景和目的:在创伤和疑似危重出血的情况下,开始输血的指征仍不明确,潜在可避免的输血率很高。院前血乳酸测量有助于预测输血需求。本研究的目的是将护理点(POC)乳酸装置检测到的乳酸水平与实验室测量到的乳酸水平进行比较:这是一项在急诊科进行的横断面研究。符合条件的患者为疑似重大创伤和危重出血患者。采集静脉或动脉血样本。使用 StatStrip Xpress® 乳酸测量仪进行乳酸水平的 POC 测量,并与实验室值进行比较:结果:在 70 名患者中,POC 和实验室乳酸结果之间的平均差异为-0.19 mmol/L,差异范围为-1.9 和 1.5。大多数测量结果(n = 66;94.3%)都在一致范围内。POC 乳酸水平 >3.3 mmol/L 对输血的特异性大于 90%,而 POC 乳酸水平 >3.3 mmol/L 对输血的特异性小于 90%:POC 乳酸水平与实验室乳酸水平的一致性很高。因此,研究结合 POC 乳酸测量结果的院前输血临床决策规则是可行的。
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引用次数: 0
Effects of blood donor characteristics and storage on red blood cell haemoglobin β S-nitrosylation. 献血者特征和储存对红细胞血红蛋白 β S-亚硝基化的影响
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-11-21 DOI: 10.1111/vox.13768
Cuiping Zhang, Peng Huang, Ravinder J Singh, Abba C Zubair

Background and objectives: In the setting of tissue hypoxia, S-nitrosylated haemoglobin (SNO-Hb) plays crucial roles in the control of blood flow. This is associated with decreased oxygen affinity to haemoglobin and increase in tissue oxygenation. Red blood cell (RBC) transfusion is primarily performed to improve tissue oxygenation in anaemic patients. RBCs after storage undergo a variety of biochemical and functional alterations, including deficiency of nitric oxide (NO) bioactivity. However, how donor characteristics affect NO levels during RBC storage is unclear. We sought to investigate the association of blood donor age, gender and storage duration with NO and SNO-Hb levels in blood units.

Materials and methods: Blood samples from 42 healthy younger (≤30 years) and older (≥45 years) donors were collected and stored for up to 42 days. Total NO kits were used to detect total nitrite and nitrate levels in blood storage solution. SNO-Hb levels in RBCs were detected and analysed by quantitative mass spectrometry.

Results: Total NO levels in the blood storage solution significantly increased with donor age and storage duration. Proteomic analysis revealed that RBCs from older donors, particularly older females, significantly lost SNO-Hb during storage. Our findings indicate that RBCs from older donors are associated with reduced SNO-Hb levels and increased NO metabolites in storage solution after ≥35 days storage.

Conclusion: The findings suggest stored RBCs from older donors may have reduced capacity to deliver oxygen to tissues under hypoxia. A shorter shelf life may be required for storing RBCs from older donors, particularly older females.

背景和目的:在组织缺氧的情况下,S-亚硝基化血红蛋白(SNO-Hb)在控制血流量方面发挥着至关重要的作用。这与血红蛋白的氧亲和力下降和组织氧合增加有关。输注红细胞主要是为了改善贫血患者的组织氧合。储存后的红细胞会发生各种生化和功能变化,包括一氧化氮(NO)生物活性的缺乏。然而,目前还不清楚供体特征如何影响 RBC 储存过程中的一氧化氮水平。我们试图研究献血者年龄、性别和储存时间与血单位中一氧化氮和 SNO-Hb 水平的关系:收集了 42 名年轻(≤30 岁)和年长(≥45 岁)的健康献血者的血样,并将其储存长达 42 天。使用总 NO 试剂盒检测血液储存液中的总亚硝酸盐和硝酸盐水平。用定量质谱法检测和分析红细胞中的 SNO-Hb 含量:结果:血液储存液中的总氮氧化物水平随供体年龄和储存时间的延长而显著增加。蛋白质组分析表明,年龄较大的献血者,尤其是老年女性的红细胞在储存过程中明显丢失 SNO-Hb。我们的研究结果表明,年龄较大的献血者的红细胞在储存≥35 天后,储存液中的 SNO-Hb 水平降低,NO 代谢物增加:结论:研究结果表明,来自年长供体的储存红细胞在缺氧情况下向组织输送氧气的能力可能会降低。结论:研究结果表明,年龄较大的供体储存的红细胞在缺氧情况下向组织输送氧气的能力可能会降低,因此需要缩短年龄较大供体的红细胞(尤其是老年女性)的储存期限。
{"title":"Effects of blood donor characteristics and storage on red blood cell haemoglobin β S-nitrosylation.","authors":"Cuiping Zhang, Peng Huang, Ravinder J Singh, Abba C Zubair","doi":"10.1111/vox.13768","DOIUrl":"10.1111/vox.13768","url":null,"abstract":"<p><strong>Background and objectives: </strong>In the setting of tissue hypoxia, S-nitrosylated haemoglobin (SNO-Hb) plays crucial roles in the control of blood flow. This is associated with decreased oxygen affinity to haemoglobin and increase in tissue oxygenation. Red blood cell (RBC) transfusion is primarily performed to improve tissue oxygenation in anaemic patients. RBCs after storage undergo a variety of biochemical and functional alterations, including deficiency of nitric oxide (NO) bioactivity. However, how donor characteristics affect NO levels during RBC storage is unclear. We sought to investigate the association of blood donor age, gender and storage duration with NO and SNO-Hb levels in blood units.</p><p><strong>Materials and methods: </strong>Blood samples from 42 healthy younger (≤30 years) and older (≥45 years) donors were collected and stored for up to 42 days. Total NO kits were used to detect total nitrite and nitrate levels in blood storage solution. SNO-Hb levels in RBCs were detected and analysed by quantitative mass spectrometry.</p><p><strong>Results: </strong>Total NO levels in the blood storage solution significantly increased with donor age and storage duration. Proteomic analysis revealed that RBCs from older donors, particularly older females, significantly lost SNO-Hb during storage. Our findings indicate that RBCs from older donors are associated with reduced SNO-Hb levels and increased NO metabolites in storage solution after ≥35 days storage.</p><p><strong>Conclusion: </strong>The findings suggest stored RBCs from older donors may have reduced capacity to deliver oxygen to tissues under hypoxia. A shorter shelf life may be required for storing RBCs from older donors, particularly older females.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"132-139"},"PeriodicalIF":1.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Viability of Plasmodium falciparum parasites in human plasma under different storage conditions. 不同贮存条件下恶性疟原虫在人血浆中的生存能力。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-12-11 DOI: 10.1111/vox.13781
Anna Lavrentieva, Miranda S Oakley, Clifford T H Hayashi, Victoria F Majam, Anne F Eder, Carlos H Villa, Sanjai Kumar

Background and objectives: Malaria risk deferral policies are important for mitigating the risk of transfusion-transmitted malaria and apply to all transfusable components, including plasma. While donors of plasma components are deferred for malaria risk in the United States, the viability of intraerythrocytic Plasmodium falciparum parasites present in human plasma components stored under different temperatures and durations has not been previously reported.

Materials and methods: We spiked human plasma with a low level of ring-stage P. falciparum-infected red blood cells and then determined their viability in cultures after storage at room temperature (22°C), refrigeration (4°C) and frozen conditions at -20 and -80°C.

Results: P. falciparum parasites spiked in human plasma remained viable after storage at 22°C for a maximum of 7 days. When stored at 4°C, parasites were viable after 1 and 3 days of storage and only for 1 day after storage at -20°C. Storage at -80°C had a cryopreserving effect and parasites remained viable for up to 176 days, the longest period tested.

Conclusion: P. falciparum parasites can survive for short durations in human plasma when stored at room temperature, or in refrigerated or frozen conditions at -20°C. However, when stored at -80°C, viable parasites were detected for up to 176 days, the maximum duration for which viability was assessed. In summary, Plasmodium parasites can survive in human plasma under different storage conditions and pose a risk of transfusion-transmitted infection.

背景和目标:疟疾风险延迟政策对于减轻输血传播疟疾的风险非常重要,并适用于包括血浆在内的所有可输注成分。虽然在美国,血浆组分的供体因疟疾风险而被推迟,但在不同温度和持续时间下储存的人血浆组分中存在的红细胞内恶性疟原虫寄生虫的生存能力以前没有报道。材料和方法:我们在人血浆中加入低水平的环期恶性疟原虫感染的红细胞,然后在室温(22°C)、冷藏(4°C)和-20和-80°C冷冻条件下测定其在培养物中的生存能力。结果:人血浆中的恶性疟原虫在22℃下保存最多7天后仍能存活。在4°C条件下,寄生物在1天和3天后都有活力,在-20°C条件下寄生物在1天后才有活力。在-80°C的低温保存条件下,寄生虫可以存活176天,这是实验中最长的时间。结论:恶性疟原虫在室温、-20℃冷藏或冷冻条件下可在人血浆中存活较短时间。然而,当储存在-80°C时,可检测到活寄生虫长达176天,这是评估活力的最长持续时间。总之,疟原虫可以在不同的储存条件下在人血浆中存活,并具有输血传播感染的风险。
{"title":"Viability of Plasmodium falciparum parasites in human plasma under different storage conditions.","authors":"Anna Lavrentieva, Miranda S Oakley, Clifford T H Hayashi, Victoria F Majam, Anne F Eder, Carlos H Villa, Sanjai Kumar","doi":"10.1111/vox.13781","DOIUrl":"10.1111/vox.13781","url":null,"abstract":"<p><strong>Background and objectives: </strong>Malaria risk deferral policies are important for mitigating the risk of transfusion-transmitted malaria and apply to all transfusable components, including plasma. While donors of plasma components are deferred for malaria risk in the United States, the viability of intraerythrocytic Plasmodium falciparum parasites present in human plasma components stored under different temperatures and durations has not been previously reported.</p><p><strong>Materials and methods: </strong>We spiked human plasma with a low level of ring-stage P. falciparum-infected red blood cells and then determined their viability in cultures after storage at room temperature (22°C), refrigeration (4°C) and frozen conditions at -20 and -80°C.</p><p><strong>Results: </strong>P. falciparum parasites spiked in human plasma remained viable after storage at 22°C for a maximum of 7 days. When stored at 4°C, parasites were viable after 1 and 3 days of storage and only for 1 day after storage at -20°C. Storage at -80°C had a cryopreserving effect and parasites remained viable for up to 176 days, the longest period tested.</p><p><strong>Conclusion: </strong>P. falciparum parasites can survive for short durations in human plasma when stored at room temperature, or in refrigerated or frozen conditions at -20°C. However, when stored at -80°C, viable parasites were detected for up to 176 days, the maximum duration for which viability was assessed. In summary, Plasmodium parasites can survive in human plasma under different storage conditions and pose a risk of transfusion-transmitted infection.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"149-154"},"PeriodicalIF":1.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Securing commitment and control for the supply of plasma derivatives for public health systems. II: A survey of national pathways. 确保对公共卫生系统血浆衍生物供应的承诺和控制。二:国家途径调查。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-10-30 DOI: 10.1111/vox.13759
Leni von Bonsdorff, Albert Farrugia, Fabio Candura, Peter O'Leary, Miguel A Vesga, Vincenzo De Angelis

Background and objectives: Pressures on the supply of plasma-derived medicinal products (PDMPs) have led to the efforts to increase the level of plasma collected by public health authorities.

Materials and methods: Public blood collectors were assessed regarding their routes towards domestically sourced plasma and PDMPs.

Results: The collectors' operations were specified and analysed. Models were classified according to the type of plasma collection system and contract fractionation arrangements.

Conclusion: Commitment and control to a public plasma collection system are the key features that need to underpin plasma collection.

背景和目标:血浆衍生医药产品(PDMP)的供应压力促使公共卫生部门努力提高血浆采集水平:对公共采血者采集国产血浆和 PDMP 的途径进行了评估:结果:对采血者的业务进行了具体分析。根据血浆采集系统的类型和合同分馏安排对模式进行了分类:结论:对公共血浆采集系统的承诺和控制是支持血浆采集的关键因素。
{"title":"Securing commitment and control for the supply of plasma derivatives for public health systems. II: A survey of national pathways.","authors":"Leni von Bonsdorff, Albert Farrugia, Fabio Candura, Peter O'Leary, Miguel A Vesga, Vincenzo De Angelis","doi":"10.1111/vox.13759","DOIUrl":"10.1111/vox.13759","url":null,"abstract":"<p><strong>Background and objectives: </strong>Pressures on the supply of plasma-derived medicinal products (PDMPs) have led to the efforts to increase the level of plasma collected by public health authorities.</p><p><strong>Materials and methods: </strong>Public blood collectors were assessed regarding their routes towards domestically sourced plasma and PDMPs.</p><p><strong>Results: </strong>The collectors' operations were specified and analysed. Models were classified according to the type of plasma collection system and contract fractionation arrangements.</p><p><strong>Conclusion: </strong>Commitment and control to a public plasma collection system are the key features that need to underpin plasma collection.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"124-131"},"PeriodicalIF":1.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11839248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Missed opportunities: Lack of a diagnostic workup of anaemia results in a high prevalence of unidentified anaemia. 错失良机:由于缺乏对贫血症的诊断工作,导致未发现贫血症的发生率很高。
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-02-01 Epub Date: 2024-11-21 DOI: 10.1111/vox.13774
Christian Carrier, David Meltzer, Micah T Prochaska

Background and objectives: Anaemia is a treatable common condition with various aetiologies and is prevalent in hospitalized patients. However, anaemia is inconsistently worked up and treated in the inpatient setting, in part because there is no standardized inpatient diagnostic and treatment approach to anaemia. Therefore, the objective of this study was to examine the diagnostic approach and prevalence of common aetiologies of anaemia in hospitalized patients and test for an association between aetiologies of anaemia and patient characteristics.

Materials and methods: This study is a prospective observational study of hospitalized adult patients with anaemia. Patient laboratory data were used to assess the frequency of anaemia diagnostic workup and common aetiologies of anaemia.

Results: In a sample of 945 patients (mean age 58 years, 57% female and 72% Black), 30% patients had chronic anaemia, 11% had multifactorial anaemia, 5% had iron deficiency and 37% had insufficient laboratory data to determine their anaemia aetiology (unidentified aetiology). Patients with an unidentified aetiology received fewer transfusions and were more likely to be White, have longer hospital stays and have higher nadir haemoglobin levels.

Conclusion: A significant portion of hospitalized patients with anaemia did not have an identified aetiology. A standardized diagnostic algorithm could decrease this number and help patients receive appropriate treatment.

背景和目的:贫血是一种可治疗的常见病,病因多种多样,在住院病人中很普遍。然而,在住院环境中,贫血的诊断和治疗并不一致,部分原因是没有针对贫血的标准化住院诊断和治疗方法。因此,本研究的目的是检查住院患者贫血的诊断方法和常见病因的发病率,并检验贫血病因与患者特征之间的关联:本研究是一项前瞻性观察研究,对象是住院的成人贫血患者。患者的实验室数据用于评估贫血诊断工作的频率和贫血的常见病因:在 945 名患者(平均年龄 58 岁,57% 为女性,72% 为黑人)样本中,30% 的患者患有慢性贫血,11% 的患者患有多因素贫血,5% 的患者患有缺铁性贫血,37% 的患者没有足够的实验室数据来确定其贫血病因(病因不明)。病因不明的患者接受的输血次数较少,更有可能是白人,住院时间更长,最低血红蛋白水平更高:结论:相当一部分住院贫血患者的病因不明。标准化的诊断算法可以减少这一数字,帮助患者获得适当的治疗。
{"title":"Missed opportunities: Lack of a diagnostic workup of anaemia results in a high prevalence of unidentified anaemia.","authors":"Christian Carrier, David Meltzer, Micah T Prochaska","doi":"10.1111/vox.13774","DOIUrl":"10.1111/vox.13774","url":null,"abstract":"<p><strong>Background and objectives: </strong>Anaemia is a treatable common condition with various aetiologies and is prevalent in hospitalized patients. However, anaemia is inconsistently worked up and treated in the inpatient setting, in part because there is no standardized inpatient diagnostic and treatment approach to anaemia. Therefore, the objective of this study was to examine the diagnostic approach and prevalence of common aetiologies of anaemia in hospitalized patients and test for an association between aetiologies of anaemia and patient characteristics.</p><p><strong>Materials and methods: </strong>This study is a prospective observational study of hospitalized adult patients with anaemia. Patient laboratory data were used to assess the frequency of anaemia diagnostic workup and common aetiologies of anaemia.</p><p><strong>Results: </strong>In a sample of 945 patients (mean age 58 years, 57% female and 72% Black), 30% patients had chronic anaemia, 11% had multifactorial anaemia, 5% had iron deficiency and 37% had insufficient laboratory data to determine their anaemia aetiology (unidentified aetiology). Patients with an unidentified aetiology received fewer transfusions and were more likely to be White, have longer hospital stays and have higher nadir haemoglobin levels.</p><p><strong>Conclusion: </strong>A significant portion of hospitalized patients with anaemia did not have an identified aetiology. A standardized diagnostic algorithm could decrease this number and help patients receive appropriate treatment.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":"163-169"},"PeriodicalIF":1.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11839249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of immunoglobulin G homeostatic set point and recovery time in plasmapheresis donor safety monitoring: A retrospective observational cohort study.
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-01-29 DOI: 10.1111/vox.13800
Janet V Warner, Michael J Drinkwater, Gerard J Chu, Shane Kelly, Jeremy S McComish

Background and objectives: Serum immunoglobulin G (IgG) and total protein are used to monitor plasmapheresis donor safety. However, there is a lack of information from large donor cohorts to determine the best use of these measurements.

Materials and methods: We identified 230,144 plasmapheresis donors making their first donation between 1 July 2020 and 31 March 2024. IgG and total protein were measured prior to the first donation and then annually, following our donor safety monitoring protocol. We considered individuals who had not donated for 12 months to estimate intra-individual biological variability of IgG. We compared four models to predict which donors would develop IgG < 6 g/L.

Results: The IgG reference interval for the cohort was 7.67-15.6 g/L. IgG declines 5%-11% after the age of 45 years. The intra-individual biological variability of IgG (5.2%) is small, indicating that there is homeostatic set point for individual IgG. IgG is reduced by plasmapheresis but recovers to recruitment level after 12 weeks. When plasma is donated every 2-3 weeks, mean IgG plateaus 1 g/L below recruitment concentration. IgG at recruitment is the best predictor of which donors will have IgG < 6 g/L after a year of donations. Total protein is a low-value test in this context.

Conclusion: Plasmapheresis is safe and sustainable for almost every donor, at the 2-weekly frequency allowed in Australia. The donors most likely to experience unacceptably low IgG are those with very low recruitment IgG levels. These donors could be recommended 12-week intervals between donations or other donation types.

{"title":"Use of immunoglobulin G homeostatic set point and recovery time in plasmapheresis donor safety monitoring: A retrospective observational cohort study.","authors":"Janet V Warner, Michael J Drinkwater, Gerard J Chu, Shane Kelly, Jeremy S McComish","doi":"10.1111/vox.13800","DOIUrl":"https://doi.org/10.1111/vox.13800","url":null,"abstract":"<p><strong>Background and objectives: </strong>Serum immunoglobulin G (IgG) and total protein are used to monitor plasmapheresis donor safety. However, there is a lack of information from large donor cohorts to determine the best use of these measurements.</p><p><strong>Materials and methods: </strong>We identified 230,144 plasmapheresis donors making their first donation between 1 July 2020 and 31 March 2024. IgG and total protein were measured prior to the first donation and then annually, following our donor safety monitoring protocol. We considered individuals who had not donated for 12 months to estimate intra-individual biological variability of IgG. We compared four models to predict which donors would develop IgG < 6 g/L.</p><p><strong>Results: </strong>The IgG reference interval for the cohort was 7.67-15.6 g/L. IgG declines 5%-11% after the age of 45 years. The intra-individual biological variability of IgG (5.2%) is small, indicating that there is homeostatic set point for individual IgG. IgG is reduced by plasmapheresis but recovers to recruitment level after 12 weeks. When plasma is donated every 2-3 weeks, mean IgG plateaus 1 g/L below recruitment concentration. IgG at recruitment is the best predictor of which donors will have IgG < 6 g/L after a year of donations. Total protein is a low-value test in this context.</p><p><strong>Conclusion: </strong>Plasmapheresis is safe and sustainable for almost every donor, at the 2-weekly frequency allowed in Australia. The donors most likely to experience unacceptably low IgG are those with very low recruitment IgG levels. These donors could be recommended 12-week intervals between donations or other donation types.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An experimental comparison and user evaluation of three different dried plasma products.
IF 1.8 4区 医学 Q3 HEMATOLOGY Pub Date : 2025-01-27 DOI: 10.1111/vox.13798
Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman

Background and objectives: Access to blood components in pre-hospital bleeding resuscitation is challenging. Dried plasma is a logistically superior alternative, and new products are emerging. Therefore, we aimed to evaluate laboratory and practical differences in three differently produced dried plasma products.

Materials and methods: Single-donor lyophilized LyoPlas®, pooled-donor, lyophilized and pathogen-reduced OctaplasLG Powder®, and single-donor sprayed-dried FrontlineODP™ along with fresh plasma (in-house, pre-FrontlineODP and OctaplasLG) as controls were analysed (n = 8). Laboratory tests included measurements of various coagulation factors and thromboelastography. The practical evaluation of the dried plasma products included preparation time, time to dissolve the dried plasma and total time, together with subjective opinions from eight clinical users.

Results: The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%-20% loss compared with fresh plasma. More variations were observed in the single-donor products compared with the pooled products. Clot formation analysed by thromboelastography showed normal graphs. Reconstitution time was similar, ranging from on average 7-9 min. In the user evaluation, the reconstitution time and the possibility of using a plastic bag for the transfusion were emphasized as important, the latter fulfilled by two of the products.

Conclusion: The study supports that dried plasma may be produced with lyophilization or spray-drying technique, as well as with the addition of pathogen reduction, with preserved coagulation capability. The products were reconstituted in acceptable time and deemed feasible for pre-hospital use by eighth test users.

背景和目的:在院前出血抢救中获取血液成分具有挑战性。干血浆在后勤方面是一种优越的替代品,而且新产品不断涌现。因此,我们旨在评估三种不同生产方式的干血浆产品在实验室和实用性方面的差异:分析了单供体冻干 LyoPlas®、集合供体冻干和病原体还原 OctaplasLG Powder®、单供体喷雾干燥 FrontlineODP™ 以及作为对照的新鲜血浆(内部、前 FrontlineODP 和 OctaplasLG)(n = 8)。实验室检测包括各种凝血因子和血栓弹性成像的测量。对干血浆产品的实际评估包括制备时间、干血浆溶解时间和总时间,以及八位临床用户的主观意见:结果:所有干血浆的凝血因子含量都在人体参考范围内,与新鲜血浆相比,大约损失 10%-20%。与集合产品相比,单供体产品的差异更大。血栓弹力图分析显示血栓形成情况正常。重组时间相似,平均为 7-9 分钟。在用户评估中,重组时间和使用塑料袋输血的可能性被强调为非常重要,其中有两种产品满足了后者的要求:这项研究证明,干血浆可通过冻干或喷雾干燥技术以及病原体减毒技术生产,并能保持凝血能力。这些产品可在可接受的时间内重组,并被第八位测试用户认为可在院前使用。
{"title":"An experimental comparison and user evaluation of three different dried plasma products.","authors":"Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman","doi":"10.1111/vox.13798","DOIUrl":"https://doi.org/10.1111/vox.13798","url":null,"abstract":"<p><strong>Background and objectives: </strong>Access to blood components in pre-hospital bleeding resuscitation is challenging. Dried plasma is a logistically superior alternative, and new products are emerging. Therefore, we aimed to evaluate laboratory and practical differences in three differently produced dried plasma products.</p><p><strong>Materials and methods: </strong>Single-donor lyophilized LyoPlas®, pooled-donor, lyophilized and pathogen-reduced OctaplasLG Powder®, and single-donor sprayed-dried FrontlineODP™ along with fresh plasma (in-house, pre-FrontlineODP and OctaplasLG) as controls were analysed (n = 8). Laboratory tests included measurements of various coagulation factors and thromboelastography. The practical evaluation of the dried plasma products included preparation time, time to dissolve the dried plasma and total time, together with subjective opinions from eight clinical users.</p><p><strong>Results: </strong>The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%-20% loss compared with fresh plasma. More variations were observed in the single-donor products compared with the pooled products. Clot formation analysed by thromboelastography showed normal graphs. Reconstitution time was similar, ranging from on average 7-9 min. In the user evaluation, the reconstitution time and the possibility of using a plastic bag for the transfusion were emphasized as important, the latter fulfilled by two of the products.</p><p><strong>Conclusion: </strong>The study supports that dried plasma may be produced with lyophilization or spray-drying technique, as well as with the addition of pathogen reduction, with preserved coagulation capability. The products were reconstituted in acceptable time and deemed feasible for pre-hospital use by eighth test users.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Vox Sanguinis
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