Evaluation of the BacT/ALERT 3D system for the implementation of in-house quality control sterility testing at Canadian Blood Services.

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/ALERT3D 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/ALERT3D 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.