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
Abstract
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.
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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