Abstract
Background: Until recently, Canadian Blood Services (CBS) was performing quality control sterility testing of blood components using three different processes. This study was conducted in order to standardize sterility testing at all CBS centers in a cost-effective manner using the BacT/ALERT® 3D system.
Methods: Blood components including fresh frozen plasma, platelet concentrates, and red blood cells were inoculated with eight bacterial species at target concentrations of 1 and 10 CFU/mL. Pre- and post-spiked samples were inoculated into BacT/ALERT® aerobic and anaerobic culture bottles and incubated for a maximum of 10 days. Specificity of the positive culture bottles was verified by Gram staining. Positive results obtained pre- and post-implementation of the in-house sterility testing program at CBS were collected and analyzed.
Results: The BacT/ALERT®3D system detected all bacteria in all blood components tested in this validation. Positive cultures were obtained within 28 h of incubation with the exception of Propionibacterium acnes which was detected within 134 h. The percentage of positive cultures ranged from 0.01% to 0.2%. All contaminants isolated were either normal skin flora or environmental microorganisms.
Conclusions: This study demonstrates the capability of the BacT/ALERT®3D system to detect aerobic and anaerobic bacterial contamination in all tested blood components, thereby supporting its use for quality control sterility testing and not only bacterial screening. A standardized process will allow CBS to evaluate and compare blood collection and manufacturing practices across the country.
Clin Chem Lab Med 2010;48:1179–87.
©2010 by Walter de Gruyter Berlin New York
