Routine bacterial screening of platelet concentrates by flow cytometry and its impact on product safety and supply

B Müller1, G Walther-Wenke, M Kalus

  • 1GRC-West Blood Donation Service, Central Laboratory Hagen, Hagen, Germany.

Vox Sanguinis
|December 4, 2014
PubMed
Abstract

Insights

The BactiFlow flow cytometry test effectively screens platelet concentrates (PCs) for bacterial contamination, preventing unsafe transfusions. This rapid method proved reliable in a German blood donation service, with a low false-positive rate.

Area of Science:

  • Transfusion Medicine
  • Microbiology
  • Medical Technology

Background:

  • Bacterial contamination is a significant risk in platelet concentrate (PC) transfusions.
  • Bacterial screening of PCs is not mandatory in Germany.
  • The BactiFlow flow cytometry test was introduced to enhance PC safety.

Purpose of the Study:

  • To evaluate the implementation and effectiveness of the BactiFlow system for bacterial screening of PCs.
  • To determine the reliability and false-positive rate of the BactiFlow test.
  • To identify bacterial species contaminating PCs.

Main Methods:

  • A total of 34,631 PCs were tested using the BactiFlow system over 25 months.
  • Reactive and non-reactive expired PCs were further analyzed using BacT/ALERT and microbiological cultivation.
  • Bacterial species were identified for confirmed positive results.

Main Results:

  • 228 PCs (0.7%) showed initially reactive BactiFlow results; 24 were reproducible.
  • A confirmed false-positive rate of 0.03% was determined for BactiFlow.
  • Identified contaminants included S. aureus, S. epidermidis, S. dysgalactiae, and B. cereus.
  • 10 expired PCs showed contamination missed by BactiFlow but detected by BacT/ALERT.

Conclusions:

  • BactiFlow testing was successfully implemented as a rapid and reliable screening method for PCs.
  • The test demonstrated sufficient accuracy, with false reactive results within an acceptable range.
  • The BactiFlow system prevented the transfusion of 12 bacterially contaminated PC units.

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