Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Apr;120(4):401-410.
doi: 10.1111/vox.13803. Epub 2025 Feb 17.

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

Marcel Prax  1 , Lea Debes  1 , Michael Chudy  1 , Angela Filomena  1 , Giulio Pisani  2 , Simonetta Pupella  3 , Marie Riley  4 , Daniele Sondag-Thull  5 , Marie-Laure Hecquet  6 , Marie Pierre Emery  6 , Marie Pflieger  6 , Perrine Arnould  6
Affiliations

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

Marcel Prax et al. Vox Sang. 2025 Apr.

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.

Keywords: bacteria; blood safety; contamination; platelets; proficiency testing; quality control.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Inoculum provided in a spiking device. The device consists of a 15‐mL tube closed with a cap containing two hoses. One is sealed and can be welded to a platelet component (PC) to allow spiking in a closed system, while the other contains a breath filter and is closed via a clamp.
FIGURE 2
FIGURE 2
Schematic overview of the experimental work. In the first step, the baseline sterility of the platelet component (PC) is determined 18–24 h after production. In the second step, the blood proficiency testing scheme (B‐PTS) samples are checked visually. This is followed by artificial contamination (step three), defined as t 0h, which corresponds to the official production time. Bacterial testing is performed according to routine procedures. BE, blood establishment.
FIGURE 3
FIGURE 3
Visual quality control (QC) of test samples. Left: Normal samples with a white/creamy colour and a loose appearance. Right: Compromised sample with a brownish colour and a sticky appearance.
See this image and copyright information in PMC

References

    1. The European Commission . Summary of the 2023 Annual Reporting of Serious Adverse Reactions and Events for Blood and Blood Components; 2024. Available from: https://health.ec.europa.eu/document/download/ff51e2d1‐796b‐426f‐a941‐db.... Last accessed 5 Sep 2024.
    1. Candotti D. Viruses special issue transfusion‐transmitted viral infections. Viruses. 2022;15:86. - PMC - PubMed
    1. Faddy HM, Osiowy C, Custer B, Busch M, Stramer SL, Adesina O, et al. International review of blood donation nucleic acid amplification testing. Vox Sang. 2024;119:315–325. - PubMed
    1. Kamel H, Ramirez‐Arcos S, McDonald C. The international experience of bacterial screen testing of platelet components with automated microbial detection systems: an update. Vox Sang. 2022;117:647–655. - PubMed
    1. O'Flaherty N, Bryce L, Nolan J, Lambert M. Changing strategies for the detection of bacteria in platelet components in Ireland: from primary and secondary culture (2010–2020) to large volume delayed sampling (2020–2023). Microorganisms. 2023;11:2765. - PMC - PubMed

MeSH terms

LinkOut - more resources