实施血小板成分细菌筛选血液能力测试方案。

IF 1.8 4区 医学 Q3 HEMATOLOGY
Vox Sanguinis Pub Date : 2025-04-01 Epub Date: 2025-02-17 DOI:10.1111/vox.13803
Marcel Prax, Lea Debes, Michael Chudy, Angela Filomena, Giulio Pisani, Simonetta Pupella, Marie Riley, Daniele Sondag-Thull, Marie-Laure Hecquet, Marie Pierre Emery, Marie Pflieger, Perrine Arnould
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引用次数: 0

摘要

背景和目标:自2010年以来,欧洲药品和保健质量理事会一直在协调血液机构(BE)实验室的外部质量评估方案。为了进一步扩大研究组合,已经开发并在一项试点研究中验证了一种新的血小板成分细菌血液熟练度测试方案(B-PTS)。材料和方法:无菌样品和含有少量细菌的样品在注射装置中制备。在不同的环境条件下,评价了样品的储存和运输条件的适宜性。参与者收到了刺激装置,在现场准备了可能被污染的个人电脑,并根据他们的常规筛选程序对它们进行了测试。结果:湿度影响样品的质量。通过添加干燥剂对样品进行优化保存,保证了令人满意的质量。在初步研究中,11名参与者中有9人正确识别出阳性样本被细菌污染。结论:新开发的细菌B-PTS在中试试验中成功实施。它使实验室间的比较,以确定性能的BEs测试细菌污染的个人电脑。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Implementation of a blood proficiency testing scheme for bacterial screening of platelet components.

Background and objectives: The European Directorate for the Quality of Medicines & HealthCare has been co-ordinating an external quality assessment programme for blood establishment (BE) laboratories since 2010. To further expand the study portfolio, a new bacterial blood proficiency testing scheme (B-PTS) for platelet components (PCs) has been developed and validated in a pilot study.

Materials and methods: Sterile samples and those containing a low-count quantity of bacteria were prepared in spiking devices. Suitability of storage and shipping conditions for the samples was evaluated under different environmental conditions. Participants received the spiking devices, prepared the potentially contaminated PCs on site and tested them according to their routine screening procedures.

Results: Humidity compromised the quality of the samples. Optimized storage of the samples by adding a desiccant ensured satisfactory quality. In the pilot study, 9 of the 11 participants correctly identified the positive samples as being bacterially contaminated.

Conclusion: The newly developed bacterial B-PTS was successfully implemented in a pilot study. It enables an inter-laboratory comparison to determine the performance of BEs for the testing of bacterial contaminations in PCs.

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来源期刊
Vox Sanguinis
Vox Sanguinis 医学-血液学
CiteScore
4.40
自引率
11.10%
发文量
156
审稿时长
6-12 weeks
期刊介绍: Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.
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