Detection of bacterial contamination in platelet concentrates by a sensitive flow cytometric assay (BactiFlow): a multicentre validation study.
BACKGROUND
Bacterial contamination of platelet concentrates (PCs) still represents an ongoing risk. As a result of septic complications, particularly observed with older PCs, the shelf life of PCs has been reduced in Germany to 4 days. In this study, bacterial screening of PCs by BactiFlow (BF) flow cytometry was introduced in three German blood services to evaluate the robustness and applicability of the assay. Results were used to discuss the potential for the extension of PC shelf life to 5 days.


METHODS
A total of 1956 PCs were tested on days 4 or 5+ after PC production using the BF, whereas the BacT/Alert culture system served as reference method.


RESULTS
Two PCs were confirmed positive by culture only and were identified as Propionibacterium acnes and Staphylococcus species. Two PCs were confirmed positive for Streptococcus mitis by BF and culture. Additionally, two PCs were culture-positive only in one culture bottle (aerobic: S. mitis and anaerobic: S. hominis). Retrospective analysis of bacterial growth kinetics provide the indication that corresponding bacterial titres were most likely below the BF analytical detection limit (<150 CFU mL(-1) ) and had probably no transfusion relevance. All remaining specimens were tested negative.


CONCLUSIONS
Testing of PCs by BF was successfully implemented. The BF proved sufficient as a rapid screening method to improve PC safety. This study further provides data supporting the extension of PC shelf life to 5 days after negative BF testing on day 4.
Institut für Laboratoriums- und Transfusionsmedizin, Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
T
T
Vollmer
J
J
Dreier
V
V
Schottstedt
J
J
Bux
K
K
Tapernon
W
W
Sibrowski
K
K
Kleesiek
C
C
Knabbe
D001419:Bacteria / Q000166:cytology* / Q000254:growth & development / Q000302:isolation & purification; D001424:Bacterial Infections / Q000517:prevention & control / Q000635:transmission; D001792:Blood Platelets / Q000382:microbiology*; D001793:Blood Preservation; D017848:Blood-Borne Pathogens; D005260:Female; D005434:Flow Cytometry / Q000379:methods*; D005858:Germany; D006801:Humans; D008297:Male; D013997:Time Factors