Implementation of a blood proficiency testing scheme for bacterial screening of platelet components

被引：0

作者：

Prax, Marcel ^{[1
]}

Debes, Lea ^{[1
]}

Chudy, Michael ^{[1
]}

Filomena, Angela ^{[1
]}

Pisani, Giulio ^{[2
]}

Pupella, Simonetta ^{[3
]}

Riley, Marie ^{[4
]}

Sondag-Thull, Daniele ^{[5
]}

Hecquet, Marie-Laure ^{[6
]}

Emery, Marie Pierre ^{[6
]}

Pflieger, Marie ^{[6
]}

Arnould, Perrine ^{[6
]}

机构：

[1] Paul Ehrlich Inst PEI, Infectiol Serol, Langen, Germany

[2] Italian Natl Inst Hlth ISS, Italian Natl Blood Ctr, Rome, Italy

[3] Italian Natl Inst Hlth ISS, Natl Ctr Control & Evaluat Med, Rome, Italy

[4] Natl Blood Transfus Serv, Qual Assurance, Pieta, Malta

[5] Serv Sang, Croix Rouge Belg, Suarlee, Belgium

[6] European Directorate Qual Med & HealthCare EDQM, Intergovt Comm & Networks Dept ICND, Strasbourg, France

来源：

VOX SANGUINIS | 2025年 / 120卷 / 04期

关键词：

bacteria; blood safety; contamination; platelets; proficiency testing; quality control; CONTAMINATION; PROGRAM;

D O I：

10.1111/vox.13803

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background and ObjectivesThe 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 MethodsSterile 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.ResultsHumidity 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.ConclusionThe 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.

引用

页码：401 / 410

页数：10

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