Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data
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DOI:
10.1111/vox.12378
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发表时间:
2016-07-01
期刊:
影响因子:
2.7
通讯作者:
Acker, J. P.
Acker, J. P.
中科院分区:
医学4区
文献类型:
--
作者:
Jordan, A.;Chen, D.;Acker, J. P.

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背景和目的血液服务机构收集的质量控制(QC)数据用于监测生产并确保符合法规标准。我们演示了如何使用质量控制数据的分析来突出红细胞浓缩物(RCC)中的变异性来源。材料和方法我们将加拿大血液服务机构的QC数据与2011年6月至2014年10月期间28 227个RCC的制造和捐赠者记录进行了合并。根据加工方法、袋子制造商、供者年龄和供者性别对单位进行分类,然后根据产品特征进行评估:溶血和血红蛋白水平、单位体积、白细胞计数和血细胞比容。结果黄涂法(顶部/底部)加工的单位溶血率低于全血过滤(顶部/顶部)加工的单位。女性捐献者的单位表现出比男性捐赠者更低的溶血率。结论保存红细胞的性质受保存前处理和供体因素的影响。了解加工、献血者和RCC质量之间的关系,将有助于血液服务确保输血产品的安全。
Background and Objectives Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs).Materials and Methods We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit.Results Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma.Conclusions Stored red blood cell characteristics are influenced by pre-storage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products.