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Routine bacterial screening of platelet concentrates by flow cytometry and its impact on product safety and supply
Author(s) -
Müller B.,
WaltherWenke G.,
Kalus M.,
Alt T.,
Bux J.,
Zeiler T.,
Schottstedt V.
Publication year - 2015
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/vox.12214
Subject(s) - flow cytometry , medicine , plateletpheresis , chemistry , platelet , apheresis , immunology
Background and Objectives Bacterial contamination represents the major infectious hazard associated with transfusion of platelet concentrates ( PC s). As bacterial screening of PC s is not mandatory in G ermany, the B acti F low 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 PC s (26 411 pooled and 8220 apheresis‐derived PC s) were tested at the end of day 3 of their shelf life using the B acti F low system. PC s initially reactive in B acti F low testing and expired PC s not reactive in B acti F low on day 3 were also investigated by the B ac T / ALERT system and by microbiological cultivation in order to identify the contaminating bacterial species and to confirm reactive B acti F low results. Results Two hundred and twenty‐eight PC s (0·7%) had an initially reactive result, 24 of them remained reactive in a second test run. Out of these reproducible reactive B acti F low results, 12 could not be verified by parallel B ac T / 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 PC s (0·11%), a confirmed‐positive result was obtained in the B ac T / ALERT system which had a negative result in the B acti F low system. Conclusion Testing of PC s by B acti F low 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 PC s was prevented.