Literature DB >> 25469957

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

B Müller1, G Walther-Wenke, M Kalus, T Alt, J Bux, T Zeiler, V Schottstedt.   

Abstract

BACKGROUND AND OBJECTIVES: Bacterial contamination represents the major infectious hazard associated with transfusion of platelet concentrates (PCs). As bacterial screening of PCs is not mandatory in Germany, the BactiFlow flow cytometry test has been introduced as a rapid detection method to increase product safety.
MATERIALS AND METHODS: During a period of 25 months, a total of 34 631 PCs (26 411 pooled and 8220 apheresis-derived PCs) were tested at the end of day 3 of their shelf life using the BactiFlow system. PCs initially reactive in BactiFlow testing and expired PCs not reactive in BactiFlow on day 3 were also investigated by the BacT/ALERT system and by microbiological cultivation in order to identify the contaminating bacterial species and to confirm reactive BactiFlow results.
RESULTS: Two hundred and twenty-eight PCs (0.7%) had an initially reactive result, 24 of them remained reactive in a second test run. Out of these reproducible reactive BactiFlow results, 12 could not be verified by parallel BacT/ALERT culturing, resulting in a confirmed false-positive rate of 0.03%. The bacterial species were identified as S. aureus, S. epidermidis, S. dysgalactiae ssp. equisimilis and B. cereus. In 10 out of 9017 expired PCs (0.11%), a confirmed-positive result was obtained in the BacT/ALERT system which had a negative result in the BactiFlow system.
CONCLUSION: Testing of PCs by BactiFlow was successfully implemented in our blood donation service and proved sufficient as a rapid and reliable screening method. False reactive results are in an acceptable range since the transfusion of 12 bacterially contaminated PCs was prevented.
© 2014 International Society of Blood Transfusion.

Entities:  

Keywords:  bacterial contamination; blood donation testing; platelet concentrates

Mesh:

Year:  2014        PMID: 25469957     DOI: 10.1111/vox.12214

Source DB:  PubMed          Journal:  Vox Sang        ISSN: 0042-9007            Impact factor:   2.144


  4 in total

1.  Extension of the Storage Period of Platelet Concentrates in Germany to 5 Days by Bacterial Testing: Is it Worth the Effort?

Authors:  Tanja Vollmer; Dennis Hinse; Jürgen Diekmann; Cornelius Knabbe; Jens Dreier
Journal:  Transfus Med Hemother       Date:  2019-03-14       Impact factor: 3.747

2.  Bench Test for the Detection of Bacterial Contamination in Platelet Concentrates Using Rapid and Cultural Detection Methods with a Standardized Proficiency Panel.

Authors:  Tanja Vollmer; Cornelius Knabbe; Wolf-Jochen Geilenkeuser; Michael Schmidt; Jens Dreier
Journal:  Transfus Med Hemother       Date:  2015-07-16       Impact factor: 3.747

3.  Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions.

Authors:  Bruce S Sachais; Sarai Paradiso; Donna Strauss; Beth H Shaz
Journal:  Blood Adv       Date:  2017-06-23

Review 4.  Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients?

Authors:  Giovanni Di Minno; David Navarro; Carlo Federico Perno; Mariana Canaro; Lutz Gürtler; James W Ironside; Hermann Eichler; Andreas Tiede
Journal:  Ann Hematol       Date:  2017-06-18       Impact factor: 3.673

  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.